Medical device registration holder
Ferozsons Laboratories Limited
290 DRAP registrations and enlistments (8 Class A, 88 Class B, 78 Class C, 116 Class D) · Screen a DRAP number · Device types · Companies
DRAP lists
All devices of Ferozsons Laboratories Limited
| DRAP no. | Device | Class | Status |
|---|---|---|---|
| MDIR-0003115 | ACUITY Pro Guide Catheter | D | Valid to Jan 2027 |
| MDIR-0002967 | ACUITY Whisper View Guidewire [4640, 4641, 4642, 4643, 4647, 4648] | D | Valid to Nov 2026 |
| MDIR-0002042 | Acuity X4 (Lead, defibrillator/pacemaker , implantable) | D | Renewal passed |
| MDIR-0007928 | Acurate neo 2 Transfemoral Delivery System [SYM-DS-010] [Cardiac Valves Transcatheter Implant] | D | Valid to Feb 2030 |
| MDIR-0001691 | ACURATE neo Aortic Bioprosthesis | D | Renewal passed |
| MDIR-0004730 | Acurate neo2 Aortic Valve System [Cardiac valves, biological with support for percutaneous implantation] | D | Valid to Feb 2028 |
| MDIR-0001692 | ACURATE TF Transfemoral Delivery System | D | Renewal passed |
| MDIR-0001582 | Agent MONORAIL Paclitaxel-Coated PTCA Balloon Catheter | D | Renewal passed |
| MDIR-0000138 | Amplatz Super Stiff TM Guidewires | D | Renewal passed |
| MDIR-0001460 | AngioJet Spiroflex Monorail Thrombectomy Set | D | Renewal passed |
| MDIR-0000123 | AngioJet TM Spiroflex TM VG Monorail TM Thrombectomy Set | D | Renewal passed |
| MDIR-0001463 | Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter | D | Renewal passed |
| MDIR-0001469 | Blazer II HTD Temperature Ablation Catheter | D | Renewal passed |
| MDIR-0001471 | Blazer II Temperature Ablation Catheter | D | Renewal passed |
| MDIR-0001467 | Blazer II XP Temperature Ablation Catheter | D | Renewal passed |
| MDIR-0001472 | Blazer Open-Irrigated Ablation Catheter | D | Renewal passed |
| MDIR-0001470 | Blazer Prime HTD Temperature Ablation Cathether | D | Renewal passed |
| MDIR-0001468 | Blazer Prime XP Temperature Ablation Cathether | D | Renewal passed |
| MDIR-0004528 | Butterfly iQ+ Diagnostic Ultrasound System | D | Valid to Jan 2028 |
| MDIR-0000093 | Carotid Wallstent TM Monorail TM Closed Cell Self-Expanding Stent | D | Renewal passed |
| MDIR-0002644 | ChoICE Guidewire with ICE Hydrophilic Coating | D | Renewal passed |
| MDIR-0001465 | ChoICE Magnet Guidewire with ICE Hydrophilic Coating | D | Renewal passed |
| MDIR-0000131 | ChoICE TM PT Guidewire with ICE TM Hydrophilic Coating | D | Renewal passed |
| MDIR-0000132 | Choice TM PT Magnet Guidewire with ICE TM Hydrophilic Coating | D | Renewal passed |
| MDIR-0007369 | COMET II Pressure Guidewire (Intravascular Haemodynamic monitoring system guidewire) | D | Valid to Nov 2029 |
| MDIR-0000122 | Comet Pressure Guidewire | D | Renewal passed |
| MDIR-0003117 | CRE Pro Wireguided Esophageal/Pyloric/Co lonic/Biliary Balloon Dilatation Catheter | D | Valid to Jan 2027 |
| MDIR-0000128 | CrossBoss TM Catheter | D | Renewal passed |
| MDIR-0001476 | Dynamic Tip Unidirectional Steerable Diagnostic Catheter | D | Renewal passed |
| MDIR-0001475 | Dynamic XT Unidirectional Steerable Diagnostic Catheter | D | Renewal passed |
| MDIR-0003118 | EASYTRAK 2 IS-1 Lead (Implantable cardiac pacing lead) [4542, 4543, 4544] | D | Valid to Jan 2027 |
| MDIR-0001458 | ELUVIA Over-The-Wire Drug-Eluting Vascular Stent System | D | Renewal passed |
| MDIR-0007641 | Emblem S-ICD System [Subcutaneous Implantable Cardioverter Defibrillator [S-ICD]] [Emblem S-ICD Subcutaneous Electrode Model:3501] | D | Valid to Jan 2030 |
| MDIR-0006935 | Emerge Monorail PTCA Dilatation Catheter | D | Valid to Sep 2029 |
| MDIR-0006535 | Emerge Over-TheWire PTCA Dilatation Catheter | D | Valid to Apr 2029 |
| MDIR-0006901 | ENDOTAK RELIANCE 4-SITE Defibrillator lead, implantable | D | Valid to May 2029 |
| MDIR-0003119 | ENDOTAK RELIANCE 4-SITE implantable Defibrillator Lead [0265, 0266, 0275, 0276] | D | Valid to Jan 2027 |
| MDIR-0001477 | EP XT Unidirectional Steerable Diagnostic Catheter | D | Renewal passed |
| MDIR-0000119 | Equalizer Occlusion Balloon Catheter | D | Renewal passed |
| MDIR-0002036 | ESSENTIO MRI Model: L110 [Single Chamber Pacemakers (rate responsive)] | D | Renewal passed |
| MDIR-0002037 | ESSENTIO MRI Model: L111 Dual chamber Pacemakers (rate responsive) | D | Renewal passed |
| MDIR-0006932 | Expo Angiographic Catheter (Catheter, Angiographic) | D | Valid to Jun 2029 |
| MDIR-0001456 | Fighter Guidewire | D | Renewal passed |
| MDIR-0000277 | FilterWire EZ TM Embolic Protection System [3.5mm-5.5mm] | D | Renewal passed |
| MDIR-0001455 | Hornet Guidewire | D | Renewal passed |
| MDIR-0000047 | Imager II Angiographic Catheters | D | Renewal passed |
| MDIR-0006934 | Impulse Angiographic Catheter (Catheter, Angiographic) | D | Valid to Jun 2029 |
| MDIR-0001966 | INGEVITY MRI Implantable Lead (Defibrillator/pacemak er Lead) | D | Renewal passed |
| MDIR-0006899 | INGEVITY+ Lead Endocardial pacing and sensing leads | D | Valid to May 2029 |
| MDIR-0009289 | IntellaMap Orion High Resolution Mapping Catheter [M004RC64S0] | D | Valid to May 2030 |
| MDIR-0007643 | IntellaNav MiFi OI Ablation Catheters (Catheter, Cardiac Ablation) | D | Valid to Jan 2030 |
| MDIR-0001462 | IntellaNAV Open-Irrigated Ablation Catheter | D | Renewal passed |
| MDIR-0007642 | IntellaNav ST Ablation Catheters (Catheter, Cardiac Ablation) | D | Valid to Jan 2030 |
| MDIR-0007644 | IntellaTip MiFi Open-Irrigated Ablation Catheters (Catheter, Cardiac Ablation) | D | Valid to Jan 2030 |
| MDIR-0001464 | IntellaTip MiFi XP Temperature Ablation Catheter | D | Renewal passed |
| MDIR-0005294 | JUDO 1 Guidewire (Catheter Guidewire) [H749394151902 H749394153002] | D | Valid to Jul 2028 |
| MDIR-0005293 | JUDO 3 Guidewire (Catheter Guidewire) [H749393771902 H749393773002] | D | Valid to Jul 2028 |
| MDIR-0005292 | JUDO 6 Guidewire (Ballon Dilation Catheter Guidewire) [H749393781902 H749393783002] | D | Valid to Jul 2028 |
| MDIR-0003111 | LATITUDE Programming System, [Model 3300] | D | Valid to Jan 2027 |
| MDIR-0006933 | Mach 1 Guide Catheters (Intravascular guiding catheter, single-use) | D | Valid to Jun 2029 |
| MDIR-0001481 | MAMBA Microcatheter | D | Renewal passed |
| MDIR-0001454 | Marvel Guidewire | D | Renewal passed |
| MDIR-0007638 | Momentum CRT-D (Cardiac Resynchronization Therapy Defibrillator) | D | Valid to Jan 2030 |
| MDIR-0007637 | Momentum EL-ICD (Implantable cardioverter Defibrillator) | D | Valid to Jan 2030 |
| MDIR-0000127 | NC Emerge TM MONORAIL TM PTCA Dilatation Catheter | D | Renewal passed |
| MDIR-0006534 | NC Quantum Apex Monorail PTCA Dilatation Catheter [Catheter, Angioplasty, Balloon Dilatation, basic] | D | Valid to Apr 2029 |
| MDIR-0007370 | OptiCross 6HD60MHz Coronary Imaging Catheter (Intravascular Ultrasound Imaging Catheter, Single- Use | D | Valid to Nov 2029 |
| MDIR-0000089 | OptiCross TM 40 MHz Coronary Imaging Catheter | D | Renewal passed |
| MDIR-0001474 | Orbiter ST Bidirectional Steerable Diagnostic Catheter | D | Renewal passed |
| MDIR-0001578 | PeriVac (Pericardial Fluid Aspiration Procedure Kit) | D | Renewal passed |
| MDIR-0001466 | Polaris X Unidirectional Steerable Diagnostic Catheter | D | Renewal passed |
| MDIR-0005162 | POLARx Cryoablation Catheter System [Polarx: Cardiac Cryosurgical System Catheter Polarmap: Cardiac Mapping Catheter, Percutaneous,… | D | Valid to May 2028 |
| MDIR-0002030 | PROMUS Element Plus MONORAIL Everolimus-Eluting Coronary Stent System [Drug-eluting coronary artery stent, non-bioabsorbable-pol ymer-coated] | D | Renewal passed |
| MDIR-0001809 | PROMUS ELITE Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System | D | Renewal passed |
| MDIR-0003417 | Promus PREMIER Select MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System | D | Valid to Jun 2027 |
| MDIR-0000130 | PT Graphix TM Guidewire with ICE TM Hydrophilic Coating | D | Renewal passed |
| MDIR-0000133 | PT2 TM Guidewire | D | Renewal passed |
| MDIR-0001473 | Radia Bidirectional Steerable Diagnostic Catheter | D | Renewal passed |
| MDIR-0000098 | Ranger TM Over-the-Wire Paclitaxel-Coated PTA Balloon Catheter | D | Renewal passed |
| MDIR-0000097 | Ranger TM SL Over-The-Wire Paclitaxel-Coated PTA Balloon Catheter | D | Renewal passed |
| MDIR-0006890 | Reliance 4- Front Pace/Sense and Defibrillation Leads (Defibrillation and Pace/Sense Leads) | D | Valid to Apr 2029 |
| MDIR-0000112 | Rotalink TM Advancer Catheter Advancing Device | D | Renewal passed |
| MDIR-0000111 | Rotalink TM Burr Exchangeable Burr Catheter | D | Renewal passed |
| MDIR-0000053 | RotalinkTM Plus Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device | D | Renewal passed |
| MDIR-0007368 | ROTAPRO PreConnected Exchangeable Burr Catheter and Burr Advancing Device (Mechanical atherectomy system, coronary, line-powered) | D | Valid to Nov 2029 |
| MDIR-0004529 | Rotapro Rotational Atherectomy System [Mechanical atherectomy system, coronary, line-powered] | D | Valid to Jan 2028 |
| MDIR-0000135 | RotaWire TM and wireClip TorquerTM Guidewire and Guidewire Manipulation Device | D | Renewal passed |
| MDIR-0000095 | RunWay TM Guide Catheter | D | Renewal passed |
| MDIR-0007646 | Safari 2 Guidewires (Cardiac catheter guidewire, single- use) | D | Valid to Jan 2030 |
| MDIR-0001457 | SAMAURAI Guidewire | D | Renewal passed |
| MDIR-0007367 | SENTINEL Cerebral Protection System [Embolic capture guidewires] | D | Valid to Nov 2029 |
| MDIR-0006536 | Sterling Monorail PTA Balloon Dilatation Catheter Catheter, Balloon | D | Valid to Apr 2029 |
| MDIR-0003121 | Stingray Guidewire with hydrophilic coating | D | Valid to Jan 2027 |
| MDIR-0000094 | Stingray TM Catheter | D | Renewal passed |
| MDIR-0003120 | SUPPORTRAK Finishing Wire IS-1 [6667, 6668, 6669] | D | Valid to Jan 2027 |
| MDIR-0006892 | TheraSphere Y-90 Glass Microsphere system. [OTT-SPE-FP-700] (Permanent implant Administration Accessory Kit) | D | Valid to Apr 2029 |
| MDIR-0000129 | Threader TM Monorail TM Micro-Dilatation Catheter | D | Renewal passed |
| MDIR-0000090 | Ultra ICE Plus 9 MHz Intracardiac Echo Catheter | D | Renewal passed |
| MDIR-0000806 | VALITUDE Cardiac Re-Synchronization Therapy Pacemaker (CRT-P) | D | Renewal passed |
| MDIR-0007645 | Victory 14 Polymer Tip Guidewire with Hydrophilic Coating (Guidewire for intravascular Interventional procedures) | D | Valid to Jan 2030 |
| MDIR-0000807 | VIGILANT CRT-D Cardiac Re-Synchronization Therapy Device (CRT-D) | D | Renewal passed |
| MDIR-0001695 | VIGILANT EL ICD (Model: D232) | D | Renewal passed |
| MDIR-0001694 | VIGILANT EL ICD (Model: D233) | D | Renewal passed |
| MDIR-0000809 | VIGILANT EL ICD Implantable Cardioverter Defibrillator (ICD) | D | Renewal passed |
| MDIR-0001693 | VIGILANT X4 CRT-D (Model: G237 and G247) | D | Renewal passed |
| MDIR-0000808 | VIGILANT X4 CRT-D Cardiac Re-Synchronization Therapy Device (CRT-D) | D | Renewal passed |
| MDIR-0002010 | Viking Quadpolar Fixed Curve Diagnostic Catheter | D | Renewal passed |
| MDIR-0006538 | Visionist CRT-P (Cardiac ReSynchronization Therapy Pacemakers) | D | Valid to Apr 2029 |
| MDIR-0006900 | VISIONIST CRT-P Cardiac Resynchronization Therapy Pacemakers | D | Valid to May 2029 |
| MDIR-0002971 | VISIONIST X4 CRT-P (Model U228) [Cardiac re-synchronization therapy pacemaker] | D | Valid to Nov 2026 |
| MDIR-0001450 | Wallstent RP Endoprothesis Self-Expanding Stent | D | Renewal passed |
| MDIR-0001451 | WATCHMAN Access System [Cardiac Occluder Delivery Kit: Access System] | D | Renewal passed |
| MDIR-0004729 | Watchman Flx Left Atrial Appendage Closure Device with Delivery System | D | Valid to Feb 2028 |
| MDIR-0001452 | WATCHMANT Left Artial Appendage Closure Device with Delivery System | D | Renewal passed |
| MDIR-0001453 | Wolverine Coronary Cutting Balloon MONORAIL Microsurgical Dilatation Device | D | Renewal passed |
| MDIR-0003109 | Zoom Latitude Programming system: Programmer/Recorder /Monitor [3120] | D | Valid to Jan 2027 |
| MDIR-0000103 | 2D Helical-35 Fibered Platinum Coil | C | Renewal passed |
| MDIR-0006885 | Advanix Biliary Stent with NaviFlex RX Delivery SystemPreloaded Duodenal Bend (Polymeric Biliary Stent, non… | C | Valid to Apr 2029 |
| MDIR-0006886 | Advanix Double Pigtail Biliary Stent Polymeric Biliary Stent, non-bio absorbable | C | Valid to Apr 2029 |
| MDIR-0006888 | Advanix Pancreatic Stent Kit-Single Pigtail Stent No Leading Barb (Polymeric Biliary Stent, non-bio absorbable) | C | Valid to Apr 2029 |
| MDIR-0006221 | Advanix Pancreatic Stent Kit-Single Pigtail Stent with leading Barb | C | Valid to Jan 2029 |
| MDIR-0006887 | Advanix Pancreatic Stent Kit-Straight Stent No Leading Barb Polymeric Biliary Stent, non-bio absorbable | C | Valid to Apr 2029 |
| MDIR-0006220 | Advanix Pancreatic Stent Kit-Straight Stent No. Leading Barb (Polymeric Biliary Stent, non-bioabsorbable) | C | Valid to Jan 2029 |
| MDIR-0006222 | Advanix Pancreatic Stent Kit-Straight Stent with leading Barb (Polymeric Biliary Stent, non-bioabsorbable) | C | Valid to Jan 2029 |
| MDIR-0006889 | Advanix Pancreatic Stent-Straight No Leading Bar Polymeric Biliary Stent, non-bio absorbable | C | Valid to Apr 2029 |
| MDIR-0007366 | ALAIR Bronchial Thermoplasty System [Radio-frequency ablation system] | C | Valid to Nov 2029 |
| MDIR-0003116 | AngioJet Solent Omni OVER-THE-WIRE Thrombectomy Set | C | Valid to Jan 2027 |
| MDIR-0001459 | AngioJet Zelante DVT Over the wire Thrombectomy Set | C | Renewal passed |
| MDIR-0009290 | Autolith Touch Bipolar Electrohydraulic Lithotripter [M005466800] | C | Valid to May 2030 |
| MDIR-0006218 | BioEnterics Intragastric Balloon (BIB) System [B-40800] | C | Valid to Jan 2029 |
| MDIR-0007551 | Cardiolife Defibrillator TEC-5600 Series (Defibrillator) | C | Valid to Nov 2029 |
| MDIR-0000113 | Complex Helical-18 Fibered Platinum Coil | C | Renewal passed |
| MDIR-0007356 | Contour VL Variable Length Ureteral Stent | C | Valid to Oct 2029 |
| MDIR-0000052 | ContourTM Embolization Particles | C | Renewal passed |
| MDIR-0000117 | Direxion TM FathomTM -16 System Pre-Loaded Torqueable Microcatheter | C | Renewal passed |
| MDIR-0000118 | Direxion TM Hi-Flow TM Torqueable Microcathete | C | Renewal passed |
| MDIR-0001482 | Direxion Torqueable Microcatheter | C | Renewal passed |
| MDIR-0000115 | DirexionTM Hi-FloTM FathomTM-16 System Pre-Loaded Torqueable Microcatheter | C | Renewal passed |
| MDIR-0007647 | ENDOVIVE Gastrostomy Tube, Straight, with Enfit Connector (Gastrostomy Feeding Tubes) | C | Valid to Jan 2030 |
| MDIR-0007708 | EndoVive Standard PEG Kit (Enteral Feeding Kit) | C | Valid to Jan 2030 |
| MDIR-0000051 | Epic TM Over The Wire Self-Expanding Nitinol Stent with Delivery System | C | Renewal passed |
| MDIR-0001579 | Expel Ureteral Stent System Ureteral Stent System | C | Renewal passed |
| MDIR-0000049 | Express LD Vascular Over The Wire Premounted Stent System | C | Renewal passed |
| MDIR-0000120 | ExpressTM Vascular SD Premounted Stent System | C | Renewal passed |
| MDIR-0000293 | ExpressTM Vascular SD Premounted Stent System | C | Renewal passed |
| MDIR-0000108 | Figure 8-18 Fibered Platinum Coil | C | Renewal passed |
| MDIR-0001577 | Flexima Ureteral Stent System Kit | C | Renewal passed |
| MDIR-0008489 | Habib EndoHPB Bipolar Radiofrequency Catheter | C | Valid to Mar 2030 |
| MDIR-0007709 | HOT AXIOS Stent and Electrocautery Enhanced Delivery System | C | Valid to Jan 2030 |
| MDIR-0006907 | Hydra Irrigation System | C | Valid to May 2029 |
| MDIR-0000101 | IDC TM Interlocking Detachable Coil | C | Renewal passed |
| MDIR-0001461 | Innova Over The Wire Self Expanding Stent System | C | Renewal passed |
| MDIR-0000110 | Interlock TM 35 Fibered IDC TM Occlusion System | C | Renewal passed |
| MDIR-0000100 | Interlock TM Fibered IDC TM Occlusion System | C | Renewal passed |
| MDIR-0000102 | Jetstream TM SC Over the wire Atherectomy Catheter | C | Renewal passed |
| MDIR-0000105 | Jetstream TM XC Over the wire Atherectomy Catheter | C | Renewal passed |
| MDIR-0001484 | LeVeen CoAccess Needle Electrode System | C | Renewal passed |
| MDIR-0001483 | LeVeen SuperSlim Needle Electrode System | C | Renewal passed |
| MDIR-0000044 | LeVeen TM Standard Needle Electrode System | C | Renewal passed |
| MDIR-0007636 | MetriQ Pump,RF Cardiac Ablation System [irrigation pump, roller] | C | Valid to Jan 2030 |
| MDIR-0007639 | Momentum X4 CRT-D (cardiac Resynchronization therapy defibrillator) | C | Valid to Jan 2030 |
| MDIR-0000099 | Multi-Loop 18 Fibered Platinum Coil | C | Renewal passed |
| MDIR-0007365 | NAVIFLEX RX Delivery System [Polymeric Biliary Stent, Nonbioabsorbable] | C | Valid to Nov 2029 |
| MDIR-0001478 | Occlusion Balloon Catheter | C | Renewal passed |
| MDIR-0006219 | ORBERA365 Intragastric Balloon System [B-50012 ] | C | Valid to Jan 2029 |
| MDIR-0003112 | Percuflex Plus Ureteral Stent | C | Valid to Jan 2027 |
| MDIR-0001480 | Placehit Biliary Wallstent (Endoprosthesis for transhepatic use) | C | Renewal passed |
| MDIR-0001690 | Renegade Hi-Flo Microcatheter Kit | C | Renewal passed |
| MDIR-0000109 | Renegade TM Hi-FloTM Microcatheter Kit | C | Renewal passed |
| MDIR-0007355 | Resolution 360 Clip | C | Valid to Oct 2029 |
| MDIR-0005287 | Resolution 360 ULTRA Clip Ligation Clip, Metallic | C | Valid to Jul 2028 |
| MDIR-0007349 | Resolution Clip Device (Ligation clip, Metallic) | C | Valid to Oct 2029 |
| MDIR-0007352 | Rezum Delivery Device Kit (for BPH) | C | Valid to Oct 2029 |
| MDIR-0006898 | Rezum Generator (Electrosurgical system generator) | C | Valid to May 2029 |
| MDIR-0007353 | Rezum Generator (Electrosurgical system generator) | C | Valid to Oct 2029 |
| MDIR-0005160 | SMARTFREEZE Cryo-Console and accessories [Cardiac Cryosurgical System] | C | Valid to May 2028 |
| MDIR-0000271 | Soloist TM Single Needle Electrode M001262500 08714729122487 | C | Renewal passed |
| MDIR-0001479 | Straight-18 Fibered Platinum Coil | C | Renewal passed |
| MDIR-0007632 | Tactra Malleable Penile Prosthesis [720080-01, 720081-01, 720082-01] | C | Valid to Jan 2030 |
| MDIR-0006906 | Ultraflex Esophageal NG Stent System Polymer-metal oesophageal stent, non-sterile Bare-metal oesophageal stent, non-sterile | C | Valid to May 2029 |
| MDIR-0006539 | Ultraflex Tracheobronchial Stent System partially Covered Distal Release (Polymer-metal tracheal/bronchial stent, sterile) | C | Valid to Apr 2029 |
| MDIR-0006540 | Ultraflex Tracheobronchial Stent SystemUncovered Distal Release (Bare-metal tracheal/bronchial stent, sterile | C | Valid to Apr 2029 |
| MDIR-0006541 | Ultraflex Tracheobronchial Stent SystemUncovered Proximal Release (Bare-metal tracheal/bronchial stent, sterile | C | Valid to Apr 2029 |
| MDIR-0002125 | Umbulizer UMV-001 [Emergency Resuscitator] [Subject to Conditions at Annex-A] | C | Renewal passed |
| MDIR-0000114 | VortX TM 18 Fibered Platinum Coil | C | Renewal passed |
| MDIR-0000106 | VortX TM 35 Fibered Platinum Coil | C | Renewal passed |
| MDIR-0000104 | VortX TM Diamond-18 Fibered Platinum Coil | C | Renewal passed |
| MDIR-0006904 | WallFlex Biliary Stent System [RX Fully Covered] Polymer-metal Biliary Stent | C | Valid to May 2029 |
| MDIR-0002009 | WallFlex Enteral Duodenal Stent with Anchor Lock Delivery System | C | Renewal passed |
| MDIR-0006905 | WallFlex Esophageal Fully Covered Stent System Polymer-metal esophageal stent, nonsterile | C | Valid to May 2029 |
| MDIR-0000048 | Wallgraft TM Over the Wire Endoprosthesis with Unistep Plus Delivery System | C | Renewal passed |
| MDIR-0002014 | Wallstent Colonic and Duodenal Endoprosthesis with Unistep Plus Delivery System | C | Renewal passed |
| MDIR-0006903 | Wallstent RX Biliary Endoprosthesis Bare-metal biliary stent | C | Valid to May 2029 |
| MDIR-0000050 | Wallstent-Uni TM Endoprosthesis Self-Expanding Stent | C | Renewal passed |
| MDIR-0000092 | 2cm Peripheral Cutting Balloon TM Over The Wire Microsurgical Dilatation Device | B | Renewal passed |
| MDIR-0001580 | Accustick Needle Introducer Needle | B | Renewal passed |
| MDIR-0000043 | Accustick TM II Introducer System | B | Renewal passed |
| MDIR-0007371 | ACQUIRE (Pulmonary Endobronchial Ultrasound Fine Needle Biopsy Device) (Body Aspiration Needle-Single Use) | B | Valid to Nov 2029 |
| MDIR-0007372 | ACQUIRE [Flexible Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device- Single Use] | B | Valid to Nov 2029 |
| MDIR-0002972 | Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) device [M00555540, M00555541, M00555560, M00555561] | B | Valid to Nov 2026 |
| MDIR-0006921 | Alliance II, Single- Use Syringe/Gauge Assembly Catheter-balloon inflator, single-use | B | Valid to May 2029 |
| MDIR-0007358 | Amplatz type renal sheath | B | Valid to Oct 2029 |
| MDIR-0009808 | AVVIGO+ Multi-Modality Guidance System [Ultrasound System, Imaging, Cardiovascular] [H7492493320C0, H7492493320CR0] | B | Valid to Jul 2030 |
| MDIR-0002966 | Captivator Cold Single- Use Snare (Mechanical-cutting endoscopic polypectomy snare) [M00561101, M00561102, M00561103] | B | Valid to Nov 2026 |
| MDIR-0005281 | Captivator II SingleUse Polypectomy Snare Endoscopic electrosurgical handpiece/electrode, monopolar, single- use | B | Valid to Jul 2028 |
| MDIR-0007354 | Captivator Single-USE Polypectomy Snares (Endoscopic electrosurgical hand piece/electrode, monopolar, single use) | B | Valid to Oct 2029 |
| MDIR-0001581 | Charger PTA Balloon Dilatation Catheter (OTW) | B | Renewal passed |
| MDIR-0001584 | Coil Pusher-16 | B | Renewal passed |
| MDIR-0005289 | CoreDx Pulmonary Mini-Forceps Flexible Endoscopic Biopsy Forceps. Single Use | B | Valid to Jul 2028 |
| MDIR-0006537 | Coyote ES Monorail PTA Balloon Dilatation Catheter Peripheral angioplasty balloon catheter | B | Valid to Apr 2029 |
| MDIR-0006894 | CRE RX Biliary Balloon Dilatation Catheter Gastrointestinal Dilation Balloon Catheter | B | Valid to Apr 2029 |
| MDIR-0007363 | Dreamwire High Performance Guidewire (High Performance Guidewire) | B | Valid to Nov 2029 |
| MDIR-0008278 | Electrophysiology Cables (Connection Cables) | B | Valid to Mar 2030 |
| MDIR-0001585 | Encore 26 Inflation Device | B | Renewal passed |
| MDIR-0000116 | EncoreTM 26 Advantage Kit Inflation Device Kit | B | Renewal passed |
| MDIR-0006923 | EXALT Model D Single-Use Duodenoscope Flexible video duodenoscope, single-use | B | Valid to May 2029 |
| MDIR-0006953 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | B | Valid to Oct 2029 |
| MDIR-0002973 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle [M00555500, M00555510, M00555520, M00555501, M00555511, M00555521] | B | Valid to Nov 2026 |
| MDIR-0000136 | Fathom TM 14 Steerable Guidewire | B | Renewal passed |
| MDIR-0000137 | Fathom TM 16 Steerable Guidewire | B | Renewal passed |
| MDIR-0007362 | FFR Link FFR Signal Processing Module (Cardiovascular Ultrasound Imaging System) | B | Valid to Nov 2029 |
| MDIR-0001583 | FloSwitch HP High Pressure Flow Control Device | B | Renewal passed |
| MDIR-0000107 | Gateway TM Plus Y Adapter | B | Renewal passed |
| MDIR-0007350 | Gold Probe Single-Use Bipolar Electro Hemostasis Catheter (Endoscopic Needle, General purpose, single use) | B | Valid to Oct 2029 |
| MDIR-0002038 | Guidezilla II Guide Extension Catheter | B | Renewal passed |
| MDIR-0000126 | Guidezilla TM Guide Extension Catheter | B | Renewal passed |
| MDIR-0006893 | HURRICANE RX (Gastrointestinal Balloon Catheter) | B | Valid to Apr 2029 |
| MDIR-0003113 | Hydra Jagwire Single-Use High Performance Guidewire | B | Valid to Jan 2027 |
| MDIR-0007361 | iLab Polaris Multi-Modality Guidance System. | B | Valid to Oct 2029 |
| MDIR-0006955 | Interject Contrast Injection Therapy Needle Catheter | B | Valid to Oct 2029 |
| MDIR-0006237 | Irrigation Tubing Set (Tubing Set) [M0041160] | B | Valid to Feb 2029 |
| MDIR-0001576 | iSLEEVE INTRODUCER SET | B | Renewal passed |
| MDIR-0003114 | Jagwire High Performance Guidewire | B | Valid to Jan 2027 |
| MDIR-0001575 | Journey Guidewire | B | Renewal passed |
| MDIR-0009809 | MDU5 PLUS Motordrive Unit [Ultrasound System, Imaging, Cardiovascular] [H749MDU5PLUSF0 H749MDU5PLUSFR0] | B | Valid to Jul 2030 |
| MDIR-0005159 | MetriQ Irrigation Tubing Set [M0041170 08714729862208 MetriQ OpenIrrigation Tubing Set] | B | Valid to May 2028 |
| MDIR-0007357 | MicroKnife XL Triple Lumen Needle Knife (cannulating sphincterotome) | B | Valid to Oct 2029 |
| MDIR-0005282 | Multibite Single-Use Multiple Sample Biopsy Forceps (Flexible endoscopic biopsy forceps, single-use) | B | Valid to Jul 2028 |
| MDIR-0006897 | NaviGuide Percutaneous Access Needle (Nephrostomy catheter introduction needle) | B | Valid to May 2029 |
| MDIR-0006542 | Occluder Occlusion Balloon Catheter (Ureteropelvic Balloon Catheter) | B | Valid to Mar 2029 |
| MDIR-0006895 | Orise Gel Syringe Submucosal lift solution | B | Valid to Apr 2029 |
| MDIR-0006217 | OverTube Endoscopic Access System [OVT-027-160] | B | Valid to Jan 2029 |
| MDIR-0006896 | Percutaneous Access Set Catheter, Nephrostomy | B | Valid to May 2029 |
| MDIR-0001449 | Plantinum Plus Guidewires | B | Renewal passed |
| MDIR-0008275 | Plasti-Med Suprapubic Catheter Sets And Accessories | B | Valid to Mar 2030 |
| MDIR-0002031 | PTFE Peelable Introducer Kit | B | Renewal passed |
| MDIR-0005291 | PTFE Urological Guidewires Non-Vascular Guidewire | B | Valid to Jul 2028 |
| MDIR-0005284 | Radial Jaw 4 Single-Use Jumbo Biopsy Forceps Flexible endoscopic biopsy forceps, single-use | B | Valid to Jul 2028 |
| MDIR-0005285 | Radial Jaw 4 Single-Use Pediatric Biopsy Forceps Flexible endoscopic biopsy forceps, single-use | B | Valid to Jul 2028 |
| MDIR-0005283 | Radial Jaw 4 Single-Use Pulmonary Biopsy Forceps Flexible endoscopic biopsy forceps, single-use | B | Valid to Jul 2028 |
| MDIR-0005286 | RescueNet Retrieval Device Gastrointestinal/airway foreign body retrieval basket | B | Valid to Jul 2028 |
| MDIR-0005290 | Rotatable Snare Single-Use Polypectomy Snare Mechanical-cutting polypectomy snare Endoscopic electrosurgical handpiece/electrode, monopolar, single- use | B | Valid to Jul 2028 |
| MDIR-0000124 | Rubicon TM 14 Support Catheter | B | Renewal passed |
| MDIR-0000125 | Rubicon TM 18 Support Catheter | B | Renewal passed |
| MDIR-0000045 | Rubicon TM 35 Support Catheter | B | Renewal passed |
| MDIR-0006951 | Sensor Nitinol Wire with Hydrophilic Tip (Gastro0urological guidewire, single-use) | B | Valid to Oct 2029 |
| MDIR-0002974 | Speedband Superview Super 7 Multiple Band Ligator [M00542250, M00542251, M00542253] | B | Valid to Nov 2026 |
| MDIR-0003110 | SpyBite Biopsy Forceps [M00546270] | B | Valid to Jan 2027 |
| MDIR-0005288 | SpyBite Max Biopsy Forceps Flexible endoscopic biopsy forceps, single use | B | Valid to Jul 2028 |
| MDIR-0006922 | SpyGlass Discover Digital Catheter Flexible video choledochoscope, single-use | B | Valid to May 2029 |
| MDIR-0006952 | SpyGlass Retrieval Basket [M00546550] | B | Valid to Jun 2029 |
| MDIR-0002965 | Spyglass Retrieval Snare [M00546560] | B | Valid to Nov 2026 |
| MDIR-0007360 | SpyScope DS Access and Delivery Catheter | B | Valid to Oct 2029 |
| MDIR-0007359 | SpyScope DS II Access and Delivery Cathete | B | Valid to Oct 2029 |
| MDIR-0007364 | Starter Guidewires | B | Valid to Nov 2029 |
| MDIR-0000046 | Sterling TM Over-The-Wire PTA Balloon Dilatation Catheter | B | Renewal passed |
| MDIR-0002968 | Stone Cone Nitinol Urological Retrieval Coil (Urinary Stone Retrieval basket) | B | Valid to Nov 2026 |
| MDIR-0006238 | Super Sheath (Catheter Introducer and Interventional devices) | B | Valid to Feb 2029 |
| MDIR-0006239 | Super Sheath XL (Catheter Introducer and Interventional devices) | B | Valid to Feb 2029 |
| MDIR-0002975 | Trapezoid RX Wireguided Retrieval Basket [M00510860, M00510870, M00510880 M00510890] | B | Valid to Nov 2026 |
| MDIR-0005161 | Trapper Exchange Device Coronary angioplasty balloon catheter, basic | B | Valid to May 2028 |
| MDIR-0000288 | TruePath TM CTO Device | B | Renewal passed |
| MDIR-0007351 | TRUEtome 39 Cannulating Sphincterotome | B | Valid to Oct 2029 |
| MDIR-0006954 | Ultratome XL Triple Lumen Sphincterotome (cannulating sphincterotome) | B | Valid to Oct 2029 |
| MDIR-0008343 | Ureteral Catheter Open End Ureteral Catheter Set (Ureteral Catheter, General Purpose) | B | Valid to Mar 2030 |
| MDIR-0002969 | UroMax Ultra Balloon Dilatation Catheter (Ureteral Dilatation Catheter) | B | Valid to Nov 2026 |
| MDIR-0000278 | V-14 TM Control Wire TM Guidewire with ICE TM Hydrophilic Coating | B | Renewal passed |
| MDIR-0000134 | V-18 TM Control Wire TM Guidewire with ICE TM Hydrophilic Coating | B | Renewal passed |
| MDIR-0002970 | WATCHDOG Hemostasis Valve Kit [H74939343A020 H74939343A021] | B | Valid to Nov 2026 |
| MDIR-0000091 | XXL TM Vascular Balloon Dilatation Catheter | B | Renewal passed |
| MDIR-0006950 | Zebra Guidewire (Gastro-urological guidewire) | B | Valid to Oct 2029 |
| MDIR-0006956 | ZeroTip Nitinol Stone Retrieval Basket Urinary Stone Retrieval Basket, Single Use | B | Valid to Jun 2029 |
| MDIE-0000841 | ALLIANCE inflation syringe (Balloon Inflator) single use [M00550601 08714729129332] | A | Valid to Apr 2029 |
| MDIE-0000842 | Blox Endoscopic Bite Blocks with Elastic Cloth Strap, Endoscopic Bite Block, Basic, Single Use | A | Valid to May 2029 |
| MDIE-0000880 | Extractor Pro XL Retrieval Balloon Catheter | A | Valid to Nov 2029 |
| MDIE-0000356 | Extractor Pro XL Retrieval Balloon Catheter [M00547100 M00547110 M00547120 M00547130 M00547140 M00547150] | A | Valid to Jan 2027 |
| MDIE-0002092 | Permanent Sled Ultrasound Imaging Accessory H749393160100 | A | Valid to Jul 2030 |
| MDIE-0000879 | RX Cytology Brush (Flexible Endotherapy Cytology Brush, Single-USE) | A | Valid to Nov 2029 |
| MDIE-0000327 | SpyGlass DS Digital Controller [M00546650] | A | Valid to Nov 2026 |
| MDIE-0000843 | Tandem XL Triple Lumen ERCP Cannula | A | Valid to Oct 2029 |
Source: DRAP's published provisional lists of registered and enlisted medical devices. A screening aid, not an official DRAP verification.
