| NexGen® LPS-Flex / LPS-Mobile Bearing Knee (P060037/S077) | Zimmer, Inc. | 2022-02-10 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S038) | Medinol, Ltd. | 2022-02-10 |
| Axonics Sacral Neuromodulation System (P190006/S050) | Boston Scientific Corporation | 2022-02-10 |
| Promus Premier and Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S200) | Boston Scientific Corp | 2022-02-10 |
| Axonics Sacral Neuromodulation System (P180046/S050) | Boston Scientific Corporation | 2022-02-10 |
| myChoice CDx (P190014/S006) | Myriad Genetic Laboratories, Inc. | 2022-02-10 |
| Eversense® E3 Continuous Glucose Monitoring System (P160048/S016) | Senseonics, Incorporated | 2022-02-10 |
| Simplify® Cervical Artificial Disc (P200022/S008) | Nuvasive, Inc. | 2022-02-09 |
| AngioJet Thrombectomy System (P980037/S087) | Boston Scientific Corp | 2022-02-09 |
| CoreValve Evolut R Delivery Catheter System, CoreValve Evolut Pro Delivery Catheter System, Evolut Pro+ Delivery Ca (P130021/S108) | Medtronic, Inc. | 2022-02-09 |
| PROGEL Pleural Air Leak Sealant (P010047/S065) | Neomend, Inc. | 2022-02-09 |
| Superion Indirect Decompression System (P140004/S027) | Boston Scientific Neuromodulation | 2022-02-08 |
| Pipeline Flex, Pipeline Flex with Shield Technology (P100018/S035) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2022-02-08 |
| Revanesse Versa, Revanesse Versa + (with lidocaine), Revanesse Lips+ (with lidocaine) (P160042/S013) | Prollenium Medical Technologies, Inc. | 2022-02-08 |
| Plasmaflo OP-05W (A) (P820033/S015) | Asahi Kasei Medical Co., Ltd. | 2022-02-08 |
| PD-L1 IHC 22C3 pharmDx (P150013/S024) | Agilent Technologies, Inc. | 2022-02-08 |
| Endurant II Stent Graft System, Endurant II Aort-Uni-Illac (AUI) Stent Graft System, Endurant IIs Stent Graft System, En (P100021/S100) | Medtronic Vascular | 2022-02-07 |
| Neuroform Atlas® Stent System (P180031/S004) | Stryker Neurovascular | 2022-02-07 |
| Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spina Cord Stimulati (P840001/S508) | Medtronic Neuromodulation | 2022-02-04 |
| KARL STORZ D-Light C PDD System (P050027/S028) | KARL STORZ Endoscopy-America, Inc. | 2022-02-04 |
| FoundationOne Liquid CDx (P200006/S001) | Foundation Medicine, Inc. | 2022-02-03 |
| Optilume Urethral Drug Coated Balloon (P210020/S003) | Urotronic, Inc. | 2022-02-03 |
| RADIESSE Injectable Implant (P050037/S113) | Merz North America, Inc. | 2022-02-02 |
| Inspire Implantable Pulse Generator (IPG) (P130008/S077) | Inspire Medical Systems | 2022-02-02 |
| RADIESSE Injectable Implant, including RADIESSE Hands, RADIESSE (+) Lidocaine, and RADIESSE (+) Jawline (P050052/S134) | Merz North America, Inc. | 2022-02-02 |
| Melody Transcatheter Pulmonary Valve (P140017/S020) | Medtronic, Inc. | 2022-02-02 |
| ISPAN Perfluoropropane C3F8 Gas (P900066/S015) | Airgas Therapeutics, LLC | 2022-02-02 |
| Zilver® PTX® Drug-Eluting Peripheral Stent (P100022/S040) | Cook Ireland, Ltd. | 2022-02-02 |
| Voyant Monthly, Voyant Monthly Premium, Voyant Monthly Toric, Voyant Monthly Multifocal (P080011/S131) | CooperVision, Inc. | 2022-02-01 |
| Axonics Sacral Neuromodulation System (P180046/S044) | Boston Scientific Corporation | 2022-02-01 |
| ThermoCool SmartTouch (P030031/S125) | Biosense Webster, Inc. | 2022-02-01 |
| Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® (P840001/S505) | Medtronic Neuromodulation | 2022-02-01 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S415) | Medtronic, Inc. | 2022-02-01 |
| Micra AV TPS, Micra TPS (P150033/S133) | Medtronic, Inc. | 2022-02-01 |
| Axonics Sacral Neuromodulation System (P190006/S044) | Boston Scientific Corporation | 2022-02-01 |
| ThermoCool SmartTouch SF (P040036/S087) | Biosense Webster, Inc. | 2022-02-01 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt (P010031/S768) | Medtronic Cardiac Rhythm Disease Management | 2022-01-31 |
| PD-L1 IHC 22C3 pharmDx (P150013/S022) | Agilent Technologies, Inc. | 2022-01-31 |
| 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/S802) | Medtronic Cardiac Rhythm Disease Management | 2022-01-31 |
| Micra AV TPS, Micra TPS (P150033/S132) | Medtronic, Inc. | 2022-01-28 |
| CapSure Epicardial Pacing Lead (P950024/S102) | Medtronic, Inc. | 2022-01-28 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S702) | Medtronic, Inc. | 2022-01-28 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead (P010015/S490) | Medtronic, Inc. | 2022-01-28 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S236) | Medtronic, Inc. | 2022-01-28 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S202) | Medtronic Cardiac Rhythm Disease Management | 2022-01-28 |
| GORE® EXCLUDER® AAA Endoprosthesis (P020004/S185) | W. L. Gore & Associates, Inc. | 2022-01-28 |
| GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S148) | W. L. Gore & Associates, Inc. | 2022-01-28 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S168) | Medtronic, Inc. | 2022-01-28 |
| 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/S804) | Medtronic Cardiac Rhythm Disease Management | 2022-01-28 |
| HeartMate II Left Ventricular Assist System (P060040/S083) | ABBOTT MEDICAL | 2022-01-28 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S491) | Medtronic, Inc. | 2022-01-28 |
| Sprint Quattro Lead (P920015/S264) | Medtronic, Inc. | 2022-01-28 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S451) | Medtronic, Inc. | 2022-01-28 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S087) | W. L. Gore & Associates, Inc. | 2022-01-28 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S160) | Medtronic Cardiac Rhythm Disease Management | 2022-01-28 |
| HeartMate 3 Left Ventricular Assist System (P160054/S045) | ABBOTT MEDICAL | 2022-01-28 |
| CapSureFix MRI Lead (P090013/S319) | Medtronic, Inc. | 2022-01-28 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt (P010031/S770) | Medtronic Cardiac Rhythm Disease Management | 2022-01-28 |
| Aptima HPV Assay (P100042/S033) | Gen-Probe Incorporated | 2022-01-28 |
| lntera 3000 Hepatic Artery Infusion Pump (P890055/S079) | Intera Oncology | 2022-01-27 |
| Venaseal Closure System (P140018/S026) | Medtronic Vascular, Inc. | 2022-01-27 |
| Talent Occluder With Occluder Delivery System (P100021/S093) | Medtronic Vascular | 2022-01-27 |
| Harmony Delivery Catheter System (DCS) and Loading System (P200046/S003) | Medtronic, Inc. | 2022-01-27 |
| Micra Transcatheter Pacemaker System (P150033/S107) | Medtronic, Inc. | 2022-01-27 |
| EnVeo PRO Delivery Catheter System (DCS) and Loading System, EnVeo R Delivery Catheter System & Loading System, Evolut P (P130021/S095) | Medtronic, Inc. | 2022-01-27 |
| Optilume Urethral Drug Coated Balloon (P210020/S002) | Urotronic, Inc. | 2022-01-27 |
| Resolute Integrity Coronary Stent System (P110013/S112) | Medtronic Vascular | 2022-01-27 |
| CardioMessenger Smart 4G (P050023/S164) | Biotronik, Inc. | 2022-01-27 |
| Gambro Prismaflex TPE 2000 Set (P830063/S020) | Vantive US Healthcare, LLC | 2022-01-27 |
| Integrity Coronary Stent System (P030009/S104) | Medtronic, Ireland | 2022-01-27 |
| Resolute Onyx Coronary Stent System (P160043/S048) | Medtronic Vascular | 2022-01-27 |
| GORE CARDIOFORM Septal Occluder (P050006/S097) | W. L. Gore & Associates, Inc. | 2022-01-27 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S061) | Medtronic, Inc. | 2022-01-27 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S015) | Medtronic Vascular, Inc. | 2022-01-27 |
| IDEAL IMPLANT Structured Breast Implant (P120011/S024) | Bimini Health Tech | 2022-01-26 |
| MiSight 1 Day (omafilcon A) (P180035/S009) | CooperVision, Inc. | 2022-01-26 |
| LifeVest® Wearable Defibrillator (P010030/S155) | Zoll Manufacturing Corporation | 2022-01-26 |
| Clareon Vivity Extended Vision Hydrophobic Intraocular Lens (IOL), Clareon Vivity Toric Extended Vision Hydrophobic IO (P190018/S013) | Alcon Laboratories, LLC | 2022-01-26 |
| DUROLANE (P170007/S011) | Bioventus, LLC | 2022-01-25 |
| Axonics Sacral Neuromodulation System (P180046/S049) | Boston Scientific Corporation | 2022-01-25 |
| LifeVest® Wearable Defibrillator (P010030/S157) | Zoll Manufacturing Corporation | 2022-01-25 |
| Mara Water Vapor System (P160047/S026) | CooperSurgical, Inc. | 2022-01-25 |
| Rotablator/ROTAPRO Rotational Atherectomy System (P900056/S196) | Boston Scientific Corp | 2022-01-25 |
| Axonics Sacral Neuromodulation System (P190006/S049) | Boston Scientific Corporation | 2022-01-25 |
| CareLink SmartSync Cobalt Crome Application (P010031/S762) | Medtronic Cardiac Rhythm Disease Management | 2022-01-24 |
| Eureka! Monthly (samfilcon A) Contact Lenses (P170035/S014) | Bausch and Lomb, Inc., | 2022-01-24 |
| BD Onclarity HPV Assay (P160037/S010) | Becton, Dickinson and Company | 2022-01-24 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S139) | Edwards Lifesciences, LLC | 2022-01-23 |
| Edwards SAPIEN 3 Transcatheter Heart Valves (P200015/S017) | Edwards Lifesciences, LLC | 2022-01-23 |
| Oncomine Dx Target Test (P160045/S034) | Life Technologies Corporation | 2022-01-21 |
| LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers (P180039/S005) | DiaSorin, Inc. | 2022-01-21 |
| LIAISON® XL MUREX HBsAg Qual, LIAISON® XL MUREX Control HBsAg Qual (P190017/S003) | DiaSorin, Inc. | 2022-01-21 |
| SURGIFLO® Hemostatic Matrix Kit with Thrombin (P990004/S053) | Ferrosan Meidcal Devices A/S | 2022-01-21 |
| 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/S701) | Medtronic, Inc. | 2022-01-21 |
| SCULPTRA (P030050/S038) | Q-Med AB | 2022-01-21 |
| LIAISON® XL MUREX Anti-HBe, LIAISON® XL MUREX Control Anti-HBe (P180049/S003) | DiaSorin, Inc. | 2022-01-21 |
| LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM (P180045/S003) | DiaSorin, Inc. | 2022-01-21 |
| Micra AV TPS, Micra TPS (P150033/S131) | Medtronic, Inc. | 2022-01-21 |
| SURGICEL® Absorbable Hemostats (SURGICEL® ORIGINAL, SURGICEL® NU-KNIT , SURGICEL® FIBRILLAR, SURGICEL® SNOW) (N12159/S085) | ETHICON, Inc. | 2022-01-21 |
| LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg (P180048/S003) | DiaSorin, Inc. | 2022-01-21 |