| NextGen DRG Lead Kit and Accessories (P150004/S044) | ABBOTT MEDICAL | 2021-06-22 |
| Intera Hepatic Artery Infusion Pump (P890055/S074) | Intera Oncology | 2021-06-22 |
| Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes (P950037/S224) | Biotronik, Inc. | 2021-06-22 |
| AngelMed Guardian System (P150009/S002) | Avertix Medical, Inc. | 2021-06-21 |
| HeartWare Ventricular Assist System (P100047/S181) | Medtronic | 2021-06-21 |
| Multi-Link RX Ultra Coronary Stent System (P970020/S085) | Abbott Vascular, Inc. | 2021-06-21 |
| Micra AV TPS and Micra TPS (P150033/S102) | Medtronic, Inc. | 2021-06-21 |
| RX Herculink Elite Renal and Biliary Stent System (P110001/S014) | Abbott Vascular | 2021-06-21 |
| Micra AV TPS (P150033/S110) | Medtronic, Inc. | 2021-06-21 |
| SURGIFLO Hemostatic Matrix Kit with Thrombin (P990004/S044) | Ferrosan Meidcal Devices A/S | 2021-06-18 |
| Arctic Front Advance and Arctic Front Advance Pro Cryoablation Catheter (P100010/S110) | Medtronic Cryocath, LP | 2021-06-18 |
| Minerva Genesys HTA Endometrial Ablation System (P000040/S041) | Axora Medical, Inc. | 2021-06-17 |
| Micra AV TPS, Micra TPS (P150033/S104) | Medtronic, Inc. | 2021-06-17 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, (P130021/S096) | Medtronic, Inc. | 2021-06-17 |
| AFX2 Endovascular AAA System (P040002/S068) | Endologix, LLC | 2021-06-17 |
| 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/S784) | Medtronic Cardiac Rhythm Disease Management | 2021-06-16 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S036) | Medinol, Ltd. | 2021-06-16 |
| 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/S683) | Medtronic, Inc. | 2021-06-16 |
| Micra AV TPS, Micra TPS (P150033/S108) | Medtronic, Inc. | 2021-06-16 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S474) | Medtronic, Inc. | 2021-06-16 |
| GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S129) | W. L. Gore & Associates, Inc. | 2021-06-16 |
| 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/S746) | Medtronic Cardiac Rhythm Disease Management | 2021-06-16 |
| Acculink Carotid Stent System (P040012/S061) | Abbott Vascular | 2021-06-16 |
| TECNIS Symfony Toric Extended Range of Vision IOLs (P980040/S136) | Johnson & Johnson Surgical Vision, Inc. | 2021-06-16 |
| HeartStart FR3 Defibrillator (P160028/S004) | Philips Medical Systems, Inc. | 2021-06-15 |
| HeartStart OnSite Defibrillator and HeartStart Home Defibrillator (P160029/S012) | Philips Medical Systems, Inc. | 2021-06-15 |
| Alere NMP22 BladderChek Test (P940035/S016) | Abbott Diagnostics Scarborough, Inc. | 2021-06-15 |
| StarClose SE Vascular Closure System (P050007/S041) | Abbott Vascular Devices | 2021-06-15 |
| HeartStart FRx Defibrillator (P180028/S008) | Philips Medical Systems | 2021-06-15 |
| C-flex lntraocular Lens, C-flex Aspheric Intraocular Lens, 6.0 mm Aspheric lntraocular Lens, RayOne Aspheric, RayOne Sph (P060011/S027) | Rayner Intraocular Lenses , Ltd. | 2021-06-15 |
| Impella RP System (P170011/S029) | Abiomed, Inc. | 2021-06-15 |
| HeartStart FRx Defibrillator (P180028/S009) | Philips Medical Systems | 2021-06-15 |
| VenaSeal Closure System (P140018/S024) | Medtronic Vascular, Inc. | 2021-06-15 |
| LCS Total Knee System (P830055/S267) | Depuy, Inc. | 2021-06-14 |
| Powerheart G5 AED (P160033/S008) | ZOLL Medical Corporation | 2021-06-14 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S071) | Zimmer, Inc. | 2021-06-14 |
| Axonics Sacral Neuromodulation System (P180046/S025) | Boston Scientific Corporation | 2021-06-11 |
| Oncomine Dx Target Test (P160045/S030) | Life Technologies Corporation | 2021-06-11 |
| Restylane Refyne, Restylane Defyne, Restylane Kysse Injectable Gels (P140029/S035) | Q-Med AB | 2021-06-11 |
| Inspire Upper Airway Stimulation (UAS) (P130008/S066) | Inspire Medical Systems | 2021-06-11 |
| Axonics Sacral Neuromodulation System (P190006/S025) | Boston Scientific Corporation | 2021-06-11 |
| PreVue Pre-loaded System, IPURE Pre-loaded System (P080004/S041) | Hoya Surgical Optics, Inc. | 2021-06-10 |
| EMBLEM S-ICD Lead (P110042/S154) | Boston Scientific Corporation | 2021-06-10 |
| Defibtech's Automated External Defibrillator (AED) System (P160032/S005) | Defibtech, LLC | 2021-06-10 |
| Arctic Front Advance and Arctic Front Advance Pro (P100010/S114) | Medtronic Cryocath, LP | 2021-06-10 |
| HeartMate 3 Left Ventricular Assist System (P160054/S037) | ABBOTT MEDICAL | 2021-06-10 |
| ProACT Adjustable Continence Therapy for Men (P130018/S002) | Uromedica, Inc. | 2021-06-10 |
| Mara Water Vapor Ablation System (P160047/S021) | CooperSurgical, Inc. | 2021-06-09 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (P200030/S003) | W. L. Gore and Associates, Inc. | 2021-06-09 |
| Nucleus ABI541 Auditory Brainstem Implant System (P000015/S040) | Cochlear Americas | 2021-06-09 |
| HeartWare HVAD System (P100047/S180) | Medtronic | 2021-06-09 |
| Nucleus Hybrid Implant System (P130016/S040) | Cochlear Americas | 2021-06-09 |
| Nucleus 24 Cochlear Implant System (P970051/S190) | Cochlear Americas | 2021-06-09 |
| HeartWare Left Ventricular Assist System (P100047/S177) | Medtronic | 2021-06-09 |
| Nucleus 22 Cochlear Implant System (P840024/S091) | Cochlear Americas | 2021-06-09 |
| MISAGO RX Self-expanding Peripheral Stent System (P140002/S021) | Terumo Medical Corporation | 2021-06-09 |
| Percept and Activa Deep Brain Stimulation Therapy Systems (P960009/S385) | Medtronic, Inc. | 2021-06-09 |
| IMMULITE 2000 HBs Ag Confirmatory (P010050/S019) | Siemens Healthcare Diagnostics Products, Ltd. | 2021-06-09 |
| Seprafilm Adhesion Barrier (P950034/S053) | Baxter Healthcare Corporation | 2021-06-09 |
| Nevro Corp Senza Spinal Cord Stimulation (SCS) System (P130022/S029) | Nevro Corporation | 2021-06-09 |
| Pain PC (Vanta with AdaptiveStim , and Sequentia LT) Implantable Neurostimulation Systems and Pisces, Specify, and Ve (P840001/S471) | Medtronic Neuromodulation | 2021-06-09 |
| Nucleus 22 Cochlear Implant System (P890027/S060) | Cochlear Americas | 2021-06-09 |
| Surpass Streamline Flow Diverter System, Surpass Evolve Flow Diverter System (P170024/S008) | Stryker Neurovascular | 2021-06-09 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S175) | ABBOTT MEDICAL | 2021-06-08 |
| Radiesse Injectable Implant and Radiesse Hands (P050052/S130) | Merz North America, Inc. | 2021-06-08 |
| RELIANCE 4-FRONT Steroid-eluting Pace/Sense and Defibrillation Lead (P910073/S162) | Boston Scientific | 2021-06-08 |
| Radiesse Injectable Implant (P050037/S111) | Merz North America, Inc. | 2021-06-08 |
| LIFEPAK® CR2 Defibrillator (P170018/S013) | Physio-Control, Inc. | 2021-06-08 |
| Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S069) | ABBOTT MEDICAL | 2021-06-08 |
| samaritan Public Access Automated External Defibrillators and Accessories (P160008/S016) | Heartsine Technologies, Ltd. | 2021-06-08 |
| Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S047) | ABBOTT MEDICAL | 2021-06-08 |
| Bellafill Dermal Filler (P020012/S037) | Tiger Aesthetics Medical, LLC | 2021-06-08 |
| TECNIS Synergy IOL with TECNIS Simplicity® Delivery System, TECNIS Synergy Toric II IOL with TECNIS Simplicity® Delive (P980040/S135) | Johnson & Johnson Surgical Vision, Inc. | 2021-06-07 |
| Restore, Itrel®, Synergy® and Intellis Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® Spinal Cord S (P840001/S486) | Medtronic Neuromodulation | 2021-06-07 |
| Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S129) | CooperVision, Inc. | 2021-06-04 |
| Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039/S002) | Shockwave Medical, Inc. | 2021-06-04 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bip (P010015/S476) | Medtronic, Inc. | 2021-06-04 |
| Mentor Saline-Filled and Spectrum Breast Implants (P990075/S050) | Mentor Worldwide, LLC | 2021-06-04 |
| Mentor MemoryGel Silicone Gel-Filled Breast Implants (P030053/S060) | Mentor Corp. | 2021-06-04 |
| 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/S785) | Medtronic Cardiac Rhythm Disease Management | 2021-06-04 |
| Hydrus Microsent (P170034/S005) | Alcon Research, LLC | 2021-06-04 |
| Mentor MemoryGel Silicone Gel-Filled Breast Implants (P030053/S061) | Mentor Corp. | 2021-06-04 |
| Mentor MemoryShape Breast Implants (P060028/S040) | Mentor Worldwide, LLC | 2021-06-04 |
| Micra AV TPS, Micra TPS (P150033/S109) | Medtronic, Inc. | 2021-06-04 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra (P980035/S685) | Medtronic, Inc. | 2021-06-04 |
| Mentor MemoryShape Breast Implants (P060028/S039) | Mentor Worldwide, LLC | 2021-06-04 |
| 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/S748) | Medtronic Cardiac Rhythm Disease Management | 2021-06-04 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S121) | Vistakon, Division of Johnson & Johnson Vision Car | 2021-06-04 |
| Lutonix 018 and 035 Drug Coated Balloon PTA Catheter (P170003/S021) | Lutonix | 2021-06-03 |
| Lutonix 018 and 035 Drug Coated Balloon (P130024/S040) | Lutonix | 2021-06-03 |
| Covera Vascular Covered Stent (P170042/S009) | C.R. Bard, Inc. | 2021-06-03 |
| Ethos AquaTech Monthly, Ethos AquaTech Monthly for Astigmatism, Ethos AquaTech Monthly Multifocal (P080011/S120) | CooperVision, Inc. | 2021-06-03 |
| Venovo Venous Stent System (P180037/S005) | Bard Peripheral Vascular, Inc. | 2021-06-03 |
| LifeStent 5F Vascular Stent Systems (P070014/S062) | Bard Peripheral Vascular, Inc. | 2021-06-03 |
| MitraClip NTR/XTR Delivery System (P100009/S042) | ABBOTT MEDICAL | 2021-06-03 |
| Ophthalmic (P000046/S028) | Anika Therapeutics, Inc. | 2021-06-02 |
| DiamondTemp Ablation System (P200028/S005) | Medtronic, Inc. | 2021-06-02 |
| Pulse Generator, Permanent, Implantable (P950037/S223) | Biotronik, Inc. | 2021-06-02 |
| SURGIFOAM Absorbable Gelation Sponge, U.S.P. (P990004/S048) | Ferrosan Meidcal Devices A/S | 2021-06-02 |
| Precision Spinal Cord Stimulator Systems (P030017/S346) | Boston Scientific Corp | 2021-06-02 |