| Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System (P960043/S117) | Abbott Vascular, Inc. | 2022-08-23 |
| LifeStream® Balloon Expandable Vascular Covered Stent (P160024/S012) | Bard Peripheral Vascular, Inc. | 2022-08-23 |
| 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/S138) | Biotronik, Inc. | 2022-08-22 |
| 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/S237) | Biotronik, Inc. | 2022-08-22 |
| Proclaim DRG Systems (P150004/S057) | ABBOTT MEDICAL | 2022-08-19 |
| ENROUTE Transcarotid Stent System (P140026/S023) | Boston Scientific Corporation | 2022-08-19 |
| Proclaim SCS Systems (P010032/S187) | ABBOTT MEDICAL | 2022-08-19 |
| IsoMed Infusion System (P990034/S042) | Medtronic, Inc. | 2022-08-19 |
| Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist (P170011/S043) | Abiomed, Inc. | 2022-08-19 |
| Infinity DBS Systems (P140009/S077) | ABBOTT MEDICAL | 2022-08-19 |
| Master InterStim Therapy System, Verify Evaluation System (P970004/S367) | Medtronic Neuromodulation | 2022-08-19 |
| Inspire Implantable Pulse Generator (IPG) (P130008/S088) | Inspire Medical Systems | 2022-08-19 |
| InterStim Therapy System, Verify Evaluation System (P080025/S262) | Medtronic Neuromodulation | 2022-08-19 |
| ELCA Coronoary Laser Atherectomy Catheter (P910001/S116) | Spectranetics Corp. | 2022-08-19 |
| SynchroMed Infusion System (P860004/S395) | Medtronic, Inc. | 2022-08-19 |
| LifeVest® Wearable Defibrillator (P010030/S160) | Zoll Manufacturing Corporation | 2022-08-18 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD (P140003/S102) | Abiomed, Inc. | 2022-08-18 |
| OPTIMIZER Smart, OPTIMIZER Smart Mini (P180036/S015) | Impulse Dynamics (Usa), Inc. | 2022-08-18 |
| PROMUS PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, PROMUS ELITE Everolimus-Eluting Platinum Chro (P110010/S201) | Boston Scientific Corp | 2022-08-18 |
| Biofinity XR Toric, Biofinity Toric Multifocal (P080011/S148) | CooperVision, Inc. | 2022-08-18 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S077) | St Jude Medical | 2022-08-17 |
| eCoin Peripheral Neurostimulator (P200036/S001) | Boston Scientific Corporation | 2022-08-17 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S105) | Medtronic Vascular | 2022-08-16 |
| MitraClip G4 Clip Delivery System (P100009/S046) | ABBOTT MEDICAL | 2022-08-16 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S832) | Medtronic Cardiac Rhythm Disease Management | 2022-08-16 |
| Micra AV TPS, Micra TPS (P150033/S149) | Medtronic, Inc. | 2022-08-16 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (P200030/S009) | W. L. Gore and Associates, Inc. | 2022-08-16 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S798) | Medtronic Cardiac Rhythm Disease Management | 2022-08-16 |
| QUIK-COMBO® Therapy Cable (P160026/S033) | Physio-Control, Inc. | 2022-08-16 |
| EPi-Sense® ST Guided Coagulation System (P200002/S002) | AtriCure, Inc. | 2022-08-16 |
| LCS Total Knee System (P830055/S294) | Depuy, Inc. | 2022-08-15 |
| Sofmed breathables XW Extended Parameters, Sofmed breathables XW toric Extended Parameters (P080011/S144) | CooperVision, Inc. | 2022-08-15 |
| Natural Eyes HydraWear XW Extended Parameters, Natural Eyes HydraWear XW for Astigmatism Extended Parameters (P080011/S142) | CooperVision, Inc. | 2022-08-15 |
| C-Flex 570C, C-Flex Aspheric 970C, 600C Aspheric Intraocular Lenses (P060011/S030) | Rayner Intraocular Lenses , Ltd. | 2022-08-15 |
| NexGen® LPS-Flex / LPS-Mobile Bearing Knee (P060037/S080) | Zimmer, Inc. | 2022-08-15 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S028) | Berlin Heart, Inc. | 2022-08-12 |
| VNS Therapy System (P970003/S233) | LivaNova USA, Inc. | 2022-08-12 |
| Perfluoron (P950018/S021) | Alcon Laboratories | 2022-08-12 |
| Oncomine Dx Target Test (P160045/S036) | Life Technologies Corporation | 2022-08-11 |
| RelayPlus Thoracic Stent-Graft System (P110038/S026) | Bolton Medical, Inc. | 2022-08-11 |
| HiResolution Bionic Ear System (P960058/S155) | Advanced Bionics | 2022-08-11 |
| Oncomine Dx Target Test (P160045/S035) | Life Technologies Corporation | 2022-08-11 |
| RelayPro Thoracic Stent-Graft System (P200045/S003) | Bolton Medical, Inc. | 2022-08-11 |
| Guardant360 CDx (P200010/S008) | Guardant Health, Inc. | 2022-08-11 |
| LCS(R) Total Knee System (P830055/S293) | Depuy, Inc. | 2022-08-11 |
| LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus (P180047/S018) | DiaSorin, Inc. | 2022-08-11 |
| Master Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S434) | Medtronic, Inc. | 2022-08-10 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory, Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S037) | Abbott Laboratories | 2022-08-10 |
| ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit (P210003) | Abbott Laboratories | 2022-08-10 |
| CERAMAX® Ceramic Total Hip System (P070026/S086) | DePuy Orthopaedics, Inc. | 2022-08-10 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S725) | Medtronic, Inc. | 2022-08-09 |
| Nucleus® 24 Cochlear Implant System (P970051/S213) | Cochlear Americas | 2022-08-09 |
| Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S087) | Medtronic Sofamor Danek USA, Inc. | 2022-08-09 |
| Infuse Bone Graft (P050053/S059) | Medtronic, Inc. | 2022-08-09 |
| Consulta CRT-P, Syncra CRT-P (P010015/S504) | Medtronic, Inc. | 2022-08-09 |
| Infuse Bone Graft (P000054/S068) | Medtronic Sofamor Danek USA, Inc. | 2022-08-09 |
| PMMA Anterior Chamber Intraocular Lenses (P840039/S064) | Bausch & Lomb, Inc. | 2022-08-09 |
| Saluda Medical Evoke SCS System (P190002/S011) | Saluda Medical Pty, Ltd. | 2022-08-09 |
| Nucleus® Hybrid L24 Cochlear Implant System (P130016/S050) | Cochlear Americas | 2022-08-09 |
| HYMOVIS® (P150010/S002) | Fidia Farmaceutici | 2022-08-08 |
| R3TM Delta Ceramic Acetabular System (P150030/S023) | Smith & Nephew, Inc. | 2022-08-08 |
| TRILURON® (P180040/S002) | Fidia Farmaceutici S.P.A. | 2022-08-08 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S797) | Medtronic Cardiac Rhythm Disease Management | 2022-08-08 |
| MitraClip G4 Clip Delivery System (P100009/S045) | ABBOTT MEDICAL | 2022-08-08 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S831) | Medtronic Cardiac Rhythm Disease Management | 2022-08-08 |
| Biofinity Sphere, Biofinity Toric (P080011/S147) | CooperVision, Inc. | 2022-08-08 |
| Thoraflex Hybrid (P210006/S001) | Vascutek, Ltd. | 2022-08-08 |
| Reflection Ceramic Hip System (P030022/S049) | Smith & Nephew, Inc. | 2022-08-08 |
| Edwards Alterra Adaptive Prestent System (P200015/S020) | Edwards Lifesciences, LLC | 2022-08-08 |
| HYALGAN® (P950027/S016) | Fidia Farmaceutici S.P.A. | 2022-08-08 |
| Voluma XC, Vollure XC, Volbella XC (P110033/S067) | Allergan | 2022-08-05 |
| Juvéderm Ultra, Ultra XC, Juvéderm Ultra XC (P050047/S086) | Allergan | 2022-08-05 |
| Surpass Streamline Flow Diverter (P170024/S010) | Stryker Neurovascular | 2022-08-05 |
| Bulkamid Urethral Bulking System (P170023/S010) | Boston Scientific Corporation | 2022-08-05 |
| LIFEPAK 15 Monitor/Defibrillator (P160026/S030) | Physio-Control, Inc. | 2022-08-05 |
| Bellafill® Dermal Filler (P020012/S041) | Tiger Aesthetics Medical, LLC | 2022-08-05 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System, Orsiro Sirolimus Eluting Coronary Stent System (P170030/S026) | Biotronik AG | 2022-08-05 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S003) | W. L. Gore & Associates, Inc. | 2022-08-05 |
| Bulkamid Urethral Bulking System (P170023/S009) | Boston Scientific Corporation | 2022-08-05 |
| Bulkamid Urethral Bulking System (P170023/S011) | Boston Scientific Corporation | 2022-08-05 |
| NovaSure Impedance Controlled Endometrial Ablation System (P010013/S087) | Hologic, Inc. | 2022-08-04 |
| ISPAN Perfluoropropane C3F8 Gas (P900066/S014) | Airgas Therapeutics, LLC | 2022-08-04 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S265) | Medtronic Neuromodulation | 2022-08-04 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S370) | Medtronic Neuromodulation | 2022-08-04 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S027) | Berlin Heart, Inc. | 2022-08-04 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S433) | Medtronic, Inc. | 2022-08-03 |
| Cologuard® (P130017/S054) | Exact Sciences Corporation | 2022-08-03 |
| Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System (P130021/S119) | Medtronic, Inc. | 2022-08-03 |
| Saluda Medical Evoke SCS System (P190002/S010) | Saluda Medical Pty, Ltd. | 2022-08-03 |
| Avalus (P170006/S021) | Medtronic, Inc. | 2022-08-03 |
| Medtronic Harmony Transcatheter Pulmonary Valve System (P200046/S010) | Medtronic, Inc. | 2022-08-03 |
| Melody Transcatheter Pulmonary Valve (P140017/S022) | Medtronic, Inc. | 2022-08-03 |
| Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear; ACUVUE® Abiliti Overnight and ACUVUE® Abiliti Overni (P990018/S008) | Menicon Co, Ltd. | 2022-08-02 |
| OptiSense, Tendril STS, Tendril SDX, Tendril ST (P960013/S121) | ABBOTT MEDICAL | 2022-08-01 |
| Tendril MRI (P140033/S074) | ABBOTT MEDICAL | 2022-08-01 |
| Quickflex µ, Quartet (P030054/S400) | ABBOTT MEDICAL | 2022-08-01 |
| Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve (P150048/S066) | Edwards Lifesciences, LLC | 2022-08-01 |
| Portico Transcatheter Aortic Valve Implantation System (P190023/S009) | ABBOTT MEDICAL | 2022-08-01 |
| IsoFlex (P960030/S076) | ABBOTT MEDICAL | 2022-08-01 |
| Durata, Optisure (P950022/S143) | ABBOTT MEDICAL | 2022-08-01 |