| Open Pivot Mechanical Valve (OPHV), Open Pivot Aortic Valved Graft (AVG) (P990046/S062) | Medtronic Ats Medical, Inc. | 2022-03-10 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S117) | Boston Scientific Corp | 2022-03-09 |
| Floseal Hemostatic Matrix (P990009/S067) | Baxter Healthcare Corp | 2022-03-09 |
| Zephyr Valve Registry (ZEVR) (P180002/S020) | Pulmonx Corporation | 2022-03-09 |
| VNS Therapy PerenniaDURA Model 303 Lead (P970003/S235) | LivaNova USA, Inc. | 2022-03-09 |
| Dual Sensor (DS) Catheters (P010068/S067) | Biosense Webster, Inc. | 2022-03-08 |
| CELSIUS THERMOCOOL, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, THERMOCOOL SF, THERMOCOOL SMARTTOUCH, THERMOCOOL SMARTTOU (P030031/S122) | Biosense Webster, Inc. | 2022-03-08 |
| NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (P040036/S084) | Biosense Webster, Inc. | 2022-03-08 |
| INGEVITY MRI pace/sense lead (P150012/S123) | Boston Scientific | 2022-03-08 |
| LCS Total Knee System (P830055/S282) | Depuy, Inc. | 2022-03-08 |
| MENTOR MemoryGel Breast Implants (P030053/S065) | Mentor Corp. | 2022-03-08 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S707) | Medtronic, Inc. | 2022-03-08 |
| nGEN Pump (P990071/S051) | Biosense Webster, Inc. | 2022-03-08 |
| MENTOR MemoryShape Breast Implants (P060028/S044) | Mentor Worldwide, LLC | 2022-03-08 |
| FINELINE II pace/sense lead (P960004/S099) | Boston Scientific | 2022-03-08 |
| Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico (P070008/S134) | Biotronik, Inc. | 2022-03-08 |
| Impella RP, Impella RP with SmartAssist (P170011/S037) | Abiomed, Inc. | 2022-03-08 |
| NAVISTAR (P990025/S067) | Biosense Webster, Inc. | 2022-03-08 |
| Cordis® PALMAZ® Balloon-Expandable Stent (P890017/S022) | Cordis US Corporation | 2022-03-08 |
| RELIANCE 4-FRONT defibrillation pace/sense lead, ENDOTAK RELIANCE defibrillation pace/sense lead (P910073/S168) | Boston Scientific | 2022-03-08 |
| ACUITY Spiral Coronary Venous Pace/Sense Lead, ACUITY X4 Coronary Venous Pace/Sense Lead (P010012/S551) | Boston Scientific Corp | 2022-03-08 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos (P950037/S232) | Biotronik, Inc. | 2022-03-08 |
| Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX, (P050023/S165) | Biotronik, Inc. | 2022-03-08 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S095) | Abiomed, Inc. | 2022-03-08 |
| CELSIUS (P950005/S082) | Biosense Webster, Inc. | 2022-03-08 |
| Solo Smart Stentless Heart Valve (P130011/S010) | Corcym Canada Corp | 2022-03-07 |
| Portico (P190023/S005) | ABBOTT MEDICAL | 2022-03-07 |
| Perceval S Sutureless Heart Valve, Perceval Plus Sutureless Heart Valve (P150011/S023) | Corcym S.r.l. | 2022-03-07 |
| Axonics Sacral Neuromodulation System (P180046/S038) | Boston Scientific Corporation | 2022-03-07 |
| Carbomedics® Prosthetic Heart Valve, Carbomedics® Supra-annular Prosthetic Heart Valve (Top Hat), Carbo-Seal® Ascending (P900060/S064) | Corcym S.r.l. | 2022-03-07 |
| AMS 800 Artificial Urinary Sphincter with InhibiZone (P000053/S123) | Boston Scientific Corp | 2022-03-07 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S047) | ETHICON, Inc. | 2022-03-07 |
| Freezor Max Cardiac Cryoablation Catheter (P100010/S123) | Medtronic Cryocath, LP | 2022-03-07 |
| Axonics Sacral Neuromodulation System (P190006/S038) | Boston Scientific Corporation | 2022-03-07 |
| CERAMAX Ceramic Total Hip System (P070026/S079) | DePuy Orthopaedics, Inc. | 2022-03-05 |
| DiamondTemp Ablation Catheters (P200028/S010) | Medtronic, Inc. | 2022-03-04 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S024) | Berlin Heart, Inc. | 2022-03-04 |
| R3TM delta Ceramic Acetabular System (P150030/S016) | Smith & Nephew, Inc. | 2022-03-04 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S018) | Medtronic Vascular, Inc. | 2022-03-04 |
| Portico Transcatheter Aortic Heart Valve (P190023/S006) | ABBOTT MEDICAL | 2022-03-04 |
| Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill (P010012/S550) | Boston Scientific Corp | 2022-03-04 |
| CardioMEMS HF System (P100045/S060) | ABBOTT MEDICAL | 2022-03-04 |
| Ventak AV Acid VENTAK Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioveter Defibrillator System (P960040/S475) | Boston Scientific | 2022-03-04 |
| Siello S 45/Solia S 45, Siello S 53/Solia S 53, Siello S 60/Solia S 60 (P950037/S233) | Biotronik, Inc. | 2022-03-04 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S072) | St Jude Medical | 2022-03-04 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S058) | Beckman Coulter, Inc. | 2022-03-03 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S153) | W. L. Gore & Associates, Inc. | 2022-03-03 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S092) | W. L. Gore & Associates, Inc. | 2022-03-03 |
| Axonics Sacral Neuromodulation System (P180046/S051) | Boston Scientific Corporation | 2022-03-03 |
| Axonics Sacral Neuromodulation System (P190006/S046) | Boston Scientific Corporation | 2022-03-03 |
| Durolane (P170007/S013) | Bioventus, LLC | 2022-03-03 |
| Axonics Sacral Neuromodulation System (P180046/S046) | Boston Scientific Corporation | 2022-03-03 |
| Axonics Sacral Neuromodulation System (P190006/S051) | Boston Scientific Corporation | 2022-03-03 |
| Nucleus® 24 Cochlear Implant System (P970051/S209) | Cochlear Americas | 2022-03-03 |
| Nucleus® Hybrid L24 Cochlear Implant System (P130016/S047) | Cochlear Americas | 2022-03-03 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, (P980035/S703) | Medtronic, Inc. | 2022-03-02 |
| PHOTOFRIN 630 PDT Laser (P990021/S005) | Pinnacle Biologics, Inc. | 2022-03-02 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S055) | Abbott Diabetes Care, Inc. | 2022-03-02 |
| Freestyle Libre 14-Day Flash Glucose Monitoring System (P160030/S049) | Abbott Diabetes Care, Inc. | 2022-03-02 |
| Sorint Quattro Lead (P920015/S265) | Medtronic, Inc. | 2022-03-02 |
| Vertiflex Instrument Platform (VIP) Kit (P140004/S028) | Boston Scientific Neuromodulation | 2022-03-02 |
| DUROLANE (P170007/S012) | Bioventus, LLC | 2022-03-02 |
| Sientra OPUS Silicone Gel Breast Implants (P070004/S034) | Tiger Aesthetics Medical, LLC | 2022-03-02 |
| Cordis® Exoseal® Vascular Closure Device (P100013/S024) | Cordis US Corporation | 2022-03-01 |
| BioMimics 3D Vascular Stent System (P180003/S005) | Veryan Medical, Ltd. | 2022-03-01 |
| Melody Transcatheter Pulmonary Valve System (P140017/S021) | Medtronic, Inc. | 2022-03-01 |
| HeartWare Ventricular Assist System (P100047/S192) | Medtronic | 2022-03-01 |
| Avalus Bioprosthesis (P170006/S020) | Medtronic, Inc. | 2022-03-01 |
| Harmony Transcatheter Pulmonary Valve System (P200046/S007) | Medtronic, Inc. | 2022-03-01 |
| Evolut R Transcatheter Aortic Valve System, Evolut PRO Transcatheter Aortic Valve System, Evolut PRO+ Transcatheter Aort (P130021/S110) | Medtronic, Inc. | 2022-03-01 |
| Flow Re-Direction Endoluminal Device (FRED®) System, FREDX System (P180027/S007) | MicroVention, Inc. | 2022-03-01 |
| Trident(R) Acetabular System (P000013/S019) | Howmedica Osteonics Corp. | 2022-03-01 |
| AED Plus (P160015/S013) | ZOLL Medical Corporation | 2022-03-01 |
| eCoin Peripheral Neurostimulator (P200036) | Boston Scientific Corporation | 2022-03-01 |
| Rapid fFN for the TLiIQ System (P920048/S021) | Hologic, Inc. | 2022-02-28 |
| Sprint Quattro Lead (P920015/S266) | Medtronic, Inc. | 2022-02-28 |
| Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR (P070008/S135) | Biotronik, Inc. | 2022-02-28 |
| Guardant360® CDx (P200010/S007) | Guardant Health, Inc. | 2022-02-28 |
| Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR M (P980035/S704) | Medtronic, Inc. | 2022-02-28 |
| PreVue Pre-Loaded System (P080004/S042) | Hoya Surgical Optics, Inc. | 2022-02-28 |
| Saluda Medical Evoke SCS System (P190002) | Saluda Medical Pty, Ltd. | 2022-02-28 |
| CapSureFix Novus Lead (P930039/S239) | Medtronic, Inc. | 2022-02-28 |
| CapSure Sense Lead (P830061/S204) | Medtronic Cardiac Rhythm Disease Management | 2022-02-28 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S249) | Medtronic Neuromodulation | 2022-02-26 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S354) | Medtronic Neuromodulation | 2022-02-26 |
| Master Restore, Itrel®, Synergy®, IntellisTM and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectri (P840001/S511) | Medtronic Neuromodulation | 2022-02-26 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S420) | Medtronic, Inc. | 2022-02-26 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S386) | Medtronic, Inc. | 2022-02-26 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S237) | Medtronic, Inc. | 2022-02-25 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S807) | Medtronic Cardiac Rhythm Disease Management | 2022-02-25 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S421) | Medtronic, Inc. | 2022-02-25 |
| S.M.A.R.T. RADIANZ Vascular Stent System (P120002/S020) | Cordis US Corporation | 2022-02-25 |
| Blazer II XP Catheter, Blazer Prime XP Catheter, IntellaTip MiFi XP Catheter, IntellaNav XP Catheter and IntellaNav MiFi (P020025/S135) | Boston Scientific | 2022-02-25 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S492) | Medtronic, Inc. | 2022-02-25 |
| Aptima HBV Quant Assay (P170025/S017) | Hologic, Inc. | 2022-02-25 |
| Blazer II Catheter, Blazer II HTD Catheter, Blazer Prime HTD Catheter, and IntellaNav ST Catheter, Sterile Cables (P920047/S127) | Boston Scientific Corp | 2022-02-25 |
| REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P130030/S073) | Boston Scientific Corp | 2022-02-25 |
| Express SD Monorail Premounted Stent System (P060006/S103) | Boston Scientific Corp | 2022-02-25 |
| Micra AV TPS, Micra TPS (P150033/S135) | Medtronic, Inc. | 2022-02-25 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S013) | Boston Scientific Corporation | 2022-02-25 |