| MagtraceTM and Sentimag(R) Magnetic Locatization System (P160053/S005) | Endomagnetics Ltd., | 2022-09-13 |
| Carpentier-Edwards® PERIMOUNT Family of Pericardial Bioprostheses (P860057/S208) | Edwards Lifesciences, LLC | 2022-09-12 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KON (P150048/S067) | Edwards Lifesciences, LLC | 2022-09-12 |
| Model 2580 Patient Remote (P130008/S085) | Inspire Medical Systems | 2022-09-12 |
| Edwards INTUITY Elite Valve System (P150036/S063) | Edwards Lifesciences, LLC | 2022-09-12 |
| CELSIUS THERMOCOOL, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, THERMOCOOL SF, THERMOCOOL SMARTTOUCH (ST), THERMOCOOL SMAR (P030031/S127) | Biosense Webster, Inc. | 2022-09-09 |
| Medtronic Evolut FX Delivery Catheter and Loading Systems (P130021/S121) | Medtronic, Inc. | 2022-09-09 |
| CELSIUS (P950005/S084) | Biosense Webster, Inc. | 2022-09-09 |
| R3TM delta Ceramic Acetabular System (P150030/S014) | Smith & Nephew, Inc. | 2022-09-09 |
| Spinal Cord Stimulation (SCS) (P010032/S190) | ABBOTT MEDICAL | 2022-09-09 |
| MitraClip Clip Delivery System (P100009/S047) | ABBOTT MEDICAL | 2022-09-09 |
| Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR (P910023/S448) | ABBOTT MEDICAL | 2022-09-09 |
| Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF (P030054/S402) | ABBOTT MEDICAL | 2022-09-09 |
| NAVISTAR (P990025/S069) | Biosense Webster, Inc. | 2022-09-09 |
| HiResolution Bionic Ear System (P960058/S156) | Advanced Bionics | 2022-09-09 |
| 8mm Dual Sensor (DS) Catheters (P010068/S069) | Biosense Webster, Inc. | 2022-09-09 |
| NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (ST) (P040036/S089) | Biosense Webster, Inc. | 2022-09-09 |
| Axonics Sacral Neuromodulation System (P190006/S059) | Boston Scientific Corporation | 2022-09-08 |
| Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesi (P150048/S065) | Edwards Lifesciences, LLC | 2022-09-08 |
| Axonics Sacral Neuromodulation System (P180046/S059) | Boston Scientific Corporation | 2022-09-08 |
| HeartWare HVAD System (P100047/S200) | Medtronic | 2022-09-08 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S396) | Medtronic, Inc. | 2022-09-08 |
| Belotero Balance(R) Dermal Filler (P090016/S034) | Merz North America, Inc. | 2022-09-07 |
| Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec (P840001/S526) | Medtronic Neuromodulation | 2022-09-07 |
| Omnilink Elite Vascular Balloon-Exoandable Stent System (P110043/S013) | Abbott Vascular-Cardiac Therapies | 2022-09-07 |
| Axonics Sacral Neuromodulation System (P180046/S060) | Boston Scientific Corporation | 2022-09-07 |
| MULTI-LINK VISION RX Coronary Stent System, MULTI-LINK VISION RX 2.75 mm Coronary Stent System, MULTI-LINK MINI VISION (P020047/S075) | Abbott Vascular | 2022-09-07 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S437) | Medtronic, Inc. | 2022-09-07 |
| Axonics Sacral Neuromodulation System (P190006/S060) | Boston Scientific Corporation | 2022-09-07 |
| TRIDYNE Vascular Sealant (P150016/S022) | Neomend, Inc. | 2022-09-07 |
| MULTI-LINK RX ULTRA Coronary Stent System (P970020/S086) | Abbott Vascular, Inc. | 2022-09-07 |
| PROGEL Pleural Air Leak Sealant (P010047/S067) | Neomend, Inc. | 2022-09-06 |
| OPTIMIZER Smart System (P180036/S014) | Impulse Dynamics (Usa), Inc. | 2022-09-06 |
| Micra AV TPS and Micra TPS (P150033/S150) | Medtronic, Inc. | 2022-09-06 |
| Impella CP with SmartAssist (P140003/S105) | Abiomed, Inc. | 2022-09-06 |
| IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S067) | Medtronic, Inc. | 2022-09-02 |
| Rotablatorand ROTAPRO Rotational Atherectomy System (P900056/S200) | Boston Scientific Corp | 2022-09-02 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S387) | Medtronic, Inc. | 2022-09-02 |
| RADIESSE® Injectable Implant (P050037/S115) | Merz North America, Inc. | 2022-09-02 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (P050052/S136) | Merz North America, Inc. | 2022-09-02 |
| WATCHMAN and WATCHMAN FLX Left Atrial Appendage Closure Devices with Delivery Systems (P130013/S043) | Boston Scientific Corp | 2022-09-02 |
| Zenith Dissection Endovascular System (P180001/S006) | William Cook Europe Aps | 2022-09-01 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus Elite Everolimus-Eluting Platinum Chro (P110010/S204) | Boston Scientific Corp | 2022-09-01 |
| Master Restore, Itrel®, Synergy®, IntellisTM Spinal Cord Stimulation Systems, PiscesTM, Specify®, Vectris® Spinal Cord S (P840001/S523) | Medtronic Neuromodulation | 2022-09-01 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S128) | Vistakon, Division of Johnson & Johnson Vision Car | 2022-09-01 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S093) | W. L. Gore & Associates, Inc. | 2022-09-01 |
| GORE VIABAHN Endoprosthesis (P040037/S154) | W. L. Gore & Associates, Inc. | 2022-09-01 |
| CardioGenesis TMR System (P970029/S040) | Cryolife, Inc. | 2022-09-01 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without lnhibiZone Treatment (N970012/S192) | Boston Scientific Corp | 2022-09-01 |
| LCS Total Knee System (P830055/S295) | Depuy, Inc. | 2022-09-01 |
| R3 Delta Ceramic Hip System (P150030/S024) | Smith & Nephew, Inc. | 2022-09-01 |
| AMS 800 Artificial Urinary Sphincter (AUS) with and without lnhibiZone Treatment (P000053/S127) | Boston Scientific Corp | 2022-09-01 |
| Shockwave Intravascular Lithotripsy (IVL) Generator, Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 (P200039/S007) | Shockwave Medical, Inc. | 2022-09-01 |
| Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S022) | Biotronik AG | 2022-08-31 |
| GORE(R) EXCLUDER(R) AAA Endoprosthesis, GORE(R) EXCLUDER(R) Iliac Branch Endoprosthesis (P020004/S190) | W. L. Gore & Associates, Inc. | 2022-08-31 |
| TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis (P980052/S011) | Stryker Leibinger, GmbH & Co KG | 2022-08-31 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S079) | St Jude Medical | 2022-08-31 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist (P140003/S103) | Abiomed, Inc. | 2022-08-31 |
| Impella RP, Impella RP with SmartAssist (P170011/S045) | Abiomed, Inc. | 2022-08-31 |
| Master InterStim® Therapy System, Verify® Evaluation System (P970004/S344) | Medtronic Neuromodulation | 2022-08-30 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S030) | Berlin Heart, Inc. | 2022-08-30 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S239) | Medtronic Neuromodulation | 2022-08-30 |
| Praxis Extended RAS Panel (P160038/S023) | Illumina, Inc. | 2022-08-30 |
| iStent Trabecular Micro-Bypass Stent System, iStent inject Trabecular Micro-Bypass System, iStent inject W Trabecular Mi (P170043/S014) | Glaukos Corporation | 2022-08-29 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, (P980016/S833) | Medtronic Cardiac Rhythm Disease Management | 2022-08-29 |
| INGEVITY+ Active Fixation Pace/Sense Lead (P150012/S125) | Boston Scientific | 2022-08-29 |
| 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, Compia (P010031/S799) | Medtronic Cardiac Rhythm Disease Management | 2022-08-29 |
| Innova Vascular Self-Expanding Stent System (P140028/S074) | Boston Scientific Corporation | 2022-08-29 |
| T-SPOT. TB Test (P070006/S015) | Oxford Immunotec, Ltd. | 2022-08-29 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S050) | Boston Scientific Corp | 2022-08-29 |
| iStent Trabecular Micro-Bypass Stent System, iStent inject Trabecular Micro-Bypass System, iStent inject W Trabecular Mi (P080030/S024) | Glaukos Corporation | 2022-08-29 |
| RESONATE HF, RESONATE, RESONATE X4, MOMENTUM, MOMENTUM X4, VIGILIANT, VIGILIANT X4 (P010012/S552) | Boston Scientific Corp | 2022-08-26 |
| Activa Deep Brain Stimulation Therapy System (P960009/S436) | Medtronic, Inc. | 2022-08-26 |
| 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/S727) | Medtronic, Inc. | 2022-08-26 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Solara Bipolar CRT-P, Solara Q (P010015/S505) | Medtronic, Inc. | 2022-08-26 |
| Sprint Quattro Secure MRI SureScan Model 6947M lead, Sprint Quattro Secure S MRI SureScan Model 6935M lead (P920015/S270) | Medtronic, Inc. | 2022-08-26 |
| CapSureFix Novus MRI SureScan Lead Models 4076 and 5076 (P930039/S244) | Medtronic, Inc. | 2022-08-26 |
| InterStim Therapy System (P970004/S372) | Medtronic Neuromodulation | 2022-08-26 |
| ANGIO-SEAL VIP Vascular Closure Device (P930038/S100) | Terumo Medical Corporation | 2022-08-26 |
| LINX Reflux Management System (P100049/S029) | Torax Medical | 2022-08-26 |
| RESONATE HF, RESONATE EL, MOMENTUM EL, VIGILIANT EL, PERCIVA HF, PERCIVA (P960040/S476) | Boston Scientific | 2022-08-26 |
| Restore, Itrel, and Synergy Spinal Cord Stimulation Systems, Pisces, Resume, Specify, and Vectris Spinal Cord Stimulatio (P840001/S524) | Medtronic Neuromodulation | 2022-08-26 |
| Advisa DR MRI SureScan Model A2DR01 IPG, Advisa SR MRI SureScan Model A3SR01 IPG (P980035/S721) | Medtronic, Inc. | 2022-08-26 |
| CERAMAX® Ceramic Total Hip System (P070026/S101) | DePuy Orthopaedics, Inc. | 2022-08-26 |
| InterStim Therapy System (P080025/S267) | Medtronic Neuromodulation | 2022-08-26 |
| Evera MRI XT DR SureScan Model DDMB1D4, Evera MRI XT VR SureScan Model DVMB1DA, Evera MRI S DR SureScan Model DDMC3D4, E (P980016/S825) | Medtronic Cardiac Rhythm Disease Management | 2022-08-26 |
| CapSureFix MRI SureScan Lead Model 5086MRI (P090013/S323) | Medtronic, Inc. | 2022-08-26 |
| Express® LD Iliac Premounted Stent System (P090003/S052) | Boston Scientific Corporation | 2022-08-25 |
| 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, Compia (P010031/S800) | Medtronic Cardiac Rhythm Disease Management | 2022-08-25 |
| SpF Implantable Spinal Fusion Stimulators (P850035/S057) | Ahp Eos Buyer, Inc. | 2022-08-25 |
| EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S068) | Ahp Eos Buyer, Inc. | 2022-08-25 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, (P980016/S834) | Medtronic Cardiac Rhythm Disease Management | 2022-08-25 |
| Esteem® Totally Implantable Hearing System (P090018/S041) | Envoy Medical Corporation | 2022-08-24 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S031) | Berlin Heart, Inc. | 2022-08-24 |
| GORE® VIATORR® TIPS Endoprosthesis, GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (P040027/S092) | W. L. Gore & Associates, Inc. | 2022-08-24 |
| Coloplast Saline-Filled Testicular Prosthesis (Torosa) (P020003/S010) | Coloplast Corp. | 2022-08-24 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S062) | Coloplast Corp. | 2022-08-24 |
| Freezor TM Cardiac Cryoablation Catheter (P020045/S101) | Medtronic Cryocath, LP | 2022-08-24 |
| Artic Front Advance Cardiac Cryoablation Catheter, Arctic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S129) | Medtronic Cryocath, LP | 2022-08-24 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S726) | Medtronic, Inc. | 2022-08-23 |