| Cordis S.M.A.R.T. CONTROL Nitinol Stent System (P020036/S044) | Cordis US Corporation | 2021-04-01 |
| SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE (P950034/S052) | Baxter Healthcare Corporation | 2021-04-01 |
| Cordis PRECISE Nitinol Stent System (P030047/S042) | Cordis US Corporation | 2021-04-01 |
| Implantable System for Remodulin (P140032/S068) | Medtronic, Inc. | 2021-04-01 |
| GYNECARE INTECEED Adhesion Barrier (P880047/S039) | ETHICON, Inc. | 2021-04-01 |
| Enticos 4 DR, Enticos 4 D, Enticos 4 SR, Enticos 4 S, Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 (P950037/S219) | Biotronik, Inc. | 2021-04-01 |
| SynchroMed Infusion System (P860004/S371) | Medtronic, Inc. | 2021-04-01 |
| Ranger Paclitaxel-Coated Balloon Catheter (P190019/S009) | Boston Scientific Corporation | 2021-04-01 |
| SURGICEL Family of Absorbable Hemostats (N12159/S079) | ETHICON, Inc. | 2021-04-01 |
| PRECISE Pro Rx Nitinol Stent System (P030047/S041) | Cordis US Corporation | 2021-04-01 |
| Percepta Quadripolar CRT-P, Serena Quadripolar CRT-P (P010015/S463) | Medtronic, Inc. | 2021-04-01 |
| Simplify Cervical Artificial Disc (P200022/S003) | Nuvasive, Inc. | 2021-04-01 |
| Cordis S.M.A.R.T. CONTROL / S.M.A.R.T. Vascular Stent System (P120002/S019) | Cordis US Corporation | 2021-04-01 |
| SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S370) | Medtronic, Inc. | 2021-03-31 |
| SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S128) | Edwards Lifesciences, LLC | 2021-03-31 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S033) | Medinol, Ltd. | 2021-03-31 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S225) | Medtronic Neuromodulation | 2021-03-31 |
| coflex Interlaminar Stabilization Device (P110008/S013) | Companion Spine France | 2021-03-31 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S330) | Medtronic Neuromodulation | 2021-03-31 |
| SURGICEL FIBRILLAR Absorbable Hemostat and SURGICEL NU-KNIT Absorbable Hemostat (N12159/S078) | ETHICON, Inc. | 2021-03-31 |
| Activa Deep Brain Stimulation Therapy System and Percept PC BrainSense (P960009/S398) | Medtronic, Inc. | 2021-03-31 |
| Zenith Dissection Endovascular System (P180001/S002) | William Cook Europe Aps | 2021-03-31 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S031) | W. L. Gore & Associates, Inc. | 2021-03-31 |
| NovaSure Impedance Controlled Endometrial Ablation System (P010013/S083) | Hologic, Inc. | 2021-03-30 |
| HeartWare HVAD System (P100047/S176) | Medtronic | 2021-03-30 |
| ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S017) | Boston Scientific Corporation | 2021-03-30 |
| LOTUS Edge Valve System (P180029/S030) | Boston Scientific Corporation | 2021-03-30 |
| Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear (P040029/S017) | Euclid Vision Corporation | 2021-03-30 |
| BD FocalPoint GS Imaging System (P950009/S024) | Bd Diagnostics | 2021-03-29 |
| CapSure Sense Lead (P830061/S194) | Medtronic Cardiac Rhythm Disease Management | 2021-03-29 |
| TherOx Downstream System (P170027/S004) | Zoll Circulation, Inc. | 2021-03-29 |
| Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S001) | MicroVention, Inc. | 2021-03-29 |
| CINtec PLUS Cytology (P190024/S004) | Ventana Medical Systems, Inc. | 2021-03-29 |
| Sprint Quattro Lead (P920015/S254) | Medtronic, Inc. | 2021-03-29 |
| 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/S680) | Medtronic, Inc. | 2021-03-29 |
| CapSureFix Novus Lead (P930039/S224) | Medtronic, Inc. | 2021-03-29 |
| Micra Transcatheter Pacing System and Micra AV TPS (P150033/S099) | Medtronic, Inc. | 2021-03-26 |
| Nucleus 24 Cochlear Implant System (P970051/S204) | Cochlear Americas | 2021-03-26 |
| THERMOCOOL SMARTTOUCH SF Catheter (P030031/S109) | Biosense Webster, Inc. | 2021-03-26 |
| TherOx Downstream System (P170027/S003) | Zoll Circulation, Inc. | 2021-03-26 |
| RayOne EMV (Model RAO200E) (P060011/S025) | Rayner Intraocular Lenses , Ltd. | 2021-03-26 |
| Harmony TPV System (P200046) | Medtronic, Inc. | 2021-03-26 |
| X Series, R Series, Propaq MD, and AED Pro (P160022/S027) | ZOLL Medical Corporation | 2021-03-26 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S007) | CooperVision, Inc. | 2021-03-26 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S008) | CooperVision, Inc. | 2021-03-26 |
| GORE TAG Thoracic Endoprosthesis and GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S124) | W. L. Gore & Associates, Inc. | 2021-03-25 |
| Cobaly MRI, XT MRI RT-D and Crome MRI CRT-D (P010031/S734) | Medtronic Cardiac Rhythm Disease Management | 2021-03-25 |
| Axonics Sacral Neuromodulation (SNM) System Bowel Control (P190006/S034) | Boston Scientific Corporation | 2021-03-25 |
| Implantable System for Remodulin (P140032/S067) | Medtronic, Inc. | 2021-03-25 |
| Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG, Azure XT SR MRI IPG (P980035/S674) | Medtronic, Inc. | 2021-03-25 |
| Axonics Sacral Neuromodulation (SNM) System Urinary Control (P180046/S034) | Boston Scientific Corporation | 2021-03-25 |
| GORE EXCLUDER Iliac Branch Endoprosthesis (P020004/S180) | W. L. Gore & Associates, Inc. | 2021-03-25 |
| Cobalt MRI ICD, Cobalt XT MRI ICD and Crombe MRI ICD (P980016/S772) | Medtronic Cardiac Rhythm Disease Management | 2021-03-25 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S030) | W. L. Gore & Associates, Inc. | 2021-03-25 |
| Cologuard (P130017/S048) | Exact Sciences Corporation | 2021-03-25 |
| Attain Performa Lead and Attain Stability Quad MRI Lead (P080006/S160) | Medtronic, Inc. | 2021-03-25 |
| Drug Delivery Infusion Pumps SynchroMed (P860004/S369) | Medtronic, Inc. | 2021-03-25 |
| BSC WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S038) | Boston Scientific Corp | 2021-03-24 |
| Evolut PRO+ System (P130021/S089) | Medtronic, Inc. | 2021-03-24 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Chro (P110010/S190) | Boston Scientific Corp | 2021-03-24 |
| Therapy Cool Path Duo and Therapy Cool Flex (P110016/S074) | ABBOTT MEDICAL | 2021-03-24 |
| Therapy Cool Path (P060019/S051) | Irvine Biomedical, Inc. | 2021-03-24 |
| Therapy and Therapy Dual-8 (P040014/S043) | Irvine Biomedical, Inc. | 2021-03-24 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S072) | Boston Scientific Corp | 2021-03-24 |
| XIENCE V Everolimus Eluting Coronary Stent System (P070015/S148) | Abbott Vascular, Inc. | 2021-03-24 |
| Therapy and Therapy Dual-8 and Safire TX Ablation Catheter (P040042/S049) | Irvine Biomedical,Inc.(Ibi) | 2021-03-24 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S072) | Boston Scientific Corporation | 2021-03-24 |
| MULTI-LINK VISION, MULTI-LINK MINI VISION and MULTI-LINK 8 Coronary Stent Systems (P020047/S074) | Abbott Vascular | 2021-03-24 |
| XIENCE PRIME SV Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE (P110019/S116) | Abbott Vascular | 2021-03-24 |
| TECNIS Symfony OptiBlue Extended Range of Vision (ERV) IOL (P980040/S132) | Johnson & Johnson Surgical Vision, Inc. | 2021-03-23 |
| HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) (P160054/S035) | ABBOTT MEDICAL | 2021-03-23 |
| KONECT RESILIA Aortic Valved Conduit (AVC) (P150048/S052) | Edwards Lifesciences, LLC | 2021-03-23 |
| Bard E-Luminexx Vascular Stent (P080007/S024) | Bard Peripheral Vascular, Inc. | 2021-03-23 |
| ClearVisc Ophthalmic Viscosurgical Device (OVD) (P200025) | Bausch Health | 2021-03-23 |
| Senographe Pristina 3D and SenoClaire (P130020/S004) | GE Healthcare | 2021-03-23 |
| Bard Fluency Plus Endovascular Stent Graft (P130029/S009) | Bard Peripheral Vascular, Inc. | 2021-03-23 |
| VenaSeal Closure System (P140018/S022) | Medtronic Vascular, Inc. | 2021-03-22 |
| T-SPOT.TB TEST (P070006/S016) | Oxford Immunotec, Ltd. | 2021-03-22 |
| HeartMate 3 Left Ventricular Assist System (P160054/S034) | ABBOTT MEDICAL | 2021-03-21 |
| HeartMate II Left Ventricular Assist System (P060040/S079) | ABBOTT MEDICAL | 2021-03-21 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S127) | Edwards Lifesciences, LLC | 2021-03-19 |
| RHA 2, RHA 3, RHA 4 (P170002/S013) | Teoxane S.A. | 2021-03-19 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015/S008) | Edwards Lifesciences, LLC | 2021-03-19 |
| RxSight Light Adjustable Lens and Light Delivery Device (P160055/S018) | Rxsight, Inc. | 2021-03-19 |
| SYNERGY MEGATRON Everolimus Eluting Platinum Chromium Coronary Stent System (P150003/S071) | Boston Scientific Corporation | 2021-03-19 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S113) | Edwards Lifesciences, LLC | 2021-03-19 |
| LIFEPAK 15 Monitor/Defibrillator and LIFEPAK 20e Defibrillator/Monitor (P160026/S024) | Physio-Control, Inc. | 2021-03-19 |
| QuickFlex µ and Quartet (P030054/S390) | ABBOTT MEDICAL | 2021-03-18 |
| IsoFlex (P960030/S073) | ABBOTT MEDICAL | 2021-03-18 |
| Apollo Onyx Delivery Micro Catheter (P030004/S026) | Ev3 Neurovascular | 2021-03-18 |
| ZOLL AED 3 and ZOLL AED 3 Automatic (P160015/S011) | ZOLL Medical Corporation | 2021-03-18 |
| ZOLL AED 3 BLS (P160022/S026) | ZOLL Medical Corporation | 2021-03-18 |
| Perceval Sutureless Heart Valve, Perceval PLUS (P150011/S022) | Corcym S.r.l. | 2021-03-17 |
| Cologuard (P130017/S047) | Exact Sciences Corporation | 2021-03-17 |
| Medical Mechanical Heart Valve (P810002/S110) | ABBOTT MEDICAL | 2021-03-17 |
| TheraSphere (P200029) | Boston Scientific Corporation | 2021-03-17 |
| RxSight Light Adjustable Lens and Light Delivery System (P160055/S014) | Rxsight, Inc. | 2021-03-17 |
| 7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter, 9F Freezor MAX Cardiac Cryoabla (P020045/S094) | Medtronic Cryocath, LP | 2021-03-17 |
| Axonics Sacral Neuromodulation (SNM) System for Urinary Control (P190006/S033) | Boston Scientific Corporation | 2021-03-16 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD (P980016/S777) | Medtronic Cardiac Rhythm Disease Management | 2021-03-16 |