| Aveir VR Leadless Pacemaker (P150035/S004) | ABBOTT MEDICAL | 2023-04-14 |
| RHA® Redensity, RHA®2, RHA®3 and RHA®4 dermal fillers (P170002/S029) | Teoxane S.A. | 2023-04-14 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S077) | ABBOTT MEDICAL | 2023-04-14 |
| Microny family of Pacemakers (P970013/S092) | ABBOTT MEDICAL | 2023-04-14 |
| PSW 2301.U, NEO 2301.U (P000009/S102) | Biotronik, Inc. | 2023-04-13 |
| PSW 2301.U, NEO 2301.U (P070008/S146) | Biotronik, Inc. | 2023-04-13 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, (P130021/S135) | Medtronic, Inc. | 2023-04-13 |
| MISAGO RX SELF-EXPANDING PERIPHERAL STENT SYSTEM, R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P140002/S024) | Terumo Medical Corporation | 2023-04-13 |
| PSW 2301.U, NEO 2301.U (P950037/S246) | Biotronik, Inc. | 2023-04-13 |
| PSW 2301.U, NEO 2301.U (P050023/S173) | Biotronik, Inc. | 2023-04-13 |
| Impella CP with SmartAssist (P140003/S109) | Abiomed, Inc. | 2023-04-13 |
| LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX HBsAg Confirmatory Test (P190017/S009) | DiaSorin, Inc. | 2023-04-13 |
| VisuMax Femtosecond Laser (P150040/S013) | Carl Zeiss Meditec, Inc. | 2023-04-13 |
| 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/S817) | Medtronic Cardiac Rhythm Disease Management | 2023-04-12 |
| 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/S743) | Medtronic, Inc. | 2023-04-12 |
| InterStim Therapy System, Verify Evaluation System (P970004/S364) | Medtronic Neuromodulation | 2023-04-12 |
| 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/S819) | Medtronic Cardiac Rhythm Disease Management | 2023-04-12 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S517) | Medtronic, Inc. | 2023-04-12 |
| InterStim Therapy System, Verify Evaluation System (P080025/S259) | Medtronic Neuromodulation | 2023-04-12 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S084) | Syncardia Systems, LLC | 2023-04-12 |
| Restylane Kysse (P140029/S048) | Q-Med AB | 2023-04-12 |
| 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/S850) | Medtronic Cardiac Rhythm Disease Management | 2023-04-12 |
| Micra AV TPS, Micra TPS (P150033/S167) | Medtronic, Inc. | 2023-04-12 |
| 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/S853) | Medtronic Cardiac Rhythm Disease Management | 2023-04-12 |
| BD Onclarity HPV Assay (P160037/S014) | Becton, Dickinson and Company | 2023-04-12 |
| Zilver Vena Venous Self-Expanding Stent (P200023/S005) | Cook Ireland, Ltd. | 2023-04-10 |
| Synergy II Everolimus-Eluting Platinum Chromium Coronary Stent System MR, Synergy Megatron Everolimus-Eluting Platinum C (P150003/S094) | Boston Scientific Corporation | 2023-04-10 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S052) | Boston Scientific Corp | 2023-04-10 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter OTW, Ranger Paclitaxel-Coated PTA Balloon Catheter SL (P190019/S019) | Boston Scientific Corporation | 2023-04-10 |
| Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System MR, Promus Premier Everolimus-Eluting Platinum C (P110010/S210) | Boston Scientific Corp | 2023-04-10 |
| Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S082) | ABBOTT MEDICAL | 2023-04-07 |
| Consulta CRT-P, Syncra CRT-P (P010015/S516) | Medtronic, Inc. | 2023-04-07 |
| Oncomine Dx Target Test (P160045/S041) | Life Technologies Corporation | 2023-04-07 |
| Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S059) | ABBOTT MEDICAL | 2023-04-07 |
| Alto Abdominal Stent Graft System (P120006/S042) | Endologix, LLC | 2023-04-07 |
| MISAGO RX SELF-EXPANDING PERIPHERAL STENT SYSTEM, R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P140002/S025) | Terumo Medical Corporation | 2023-04-07 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S196) | ABBOTT MEDICAL | 2023-04-07 |
| Oxford Partial Knee (P010014/S104) | Biomet Manufacturing Corp | 2023-04-06 |
| NexGen® LPS-Flex / LPS-Mobile Bearing Knee (P060037/S083) | Zimmer, Inc. | 2023-04-06 |
| Svelte SLENDER® Sirolimus-Eluting Coronary Stent Integrated Delivery System (SLENDER IDS®), Svelte DIRECT Sirolimus-Elut (P210014/S002) | Advanced Bifurcation Systems, Inc. | 2023-04-06 |
| Adherus AutoSpray Dural Sealant, Adherus ET AutoSpray Dural Sealant (P130014/S017) | Stryker Leibinger GmbH & Co KG | 2023-04-05 |
| XIENCE PROS Everolimus Eluting Coronary Stent System (P110019/S123) | Abbott Vascular | 2023-04-05 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S274) | Medtronic Neuromodulation | 2023-04-04 |
| Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR (P070008/S148) | Biotronik, Inc. | 2023-04-04 |
| Axonics Sacral Neuromodulation System (P190006/S067) | Boston Scientific Corporation | 2023-04-04 |
| Axonics Sacral Neuromodulation System (P180046/S067) | Boston Scientific Corporation | 2023-04-04 |
| Siello T 53, Siello T 60, Siello JT 45, Siello JT 53, Solia T 53, Solia T 60, Solia JT 45, Solia JT 53, Siello S 45, Sie (P950037/S248) | Biotronik, Inc. | 2023-04-04 |
| Saluda Medical Evoke® SCS System (P190002/S016) | Saluda Medical Pty, Ltd. | 2023-04-04 |
| Edwards Commander Delivery System (P200015/S029) | Edwards Lifesciences, LLC | 2023-04-04 |
| Edwards Commander Delivery System (P140031/S146) | Edwards Lifesciences, LLC | 2023-04-04 |
| Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit (P220020) | Sirtex Medical, Inc. | 2023-04-04 |
| Plexa S 60, Plexa ProMRI S 60, Plexa ProMRI S 65, Plexa ProMRI S 75, Plexa SD 60/16, Plexa ProMRI SD 60/16, Plexa ProMRI (P980023/S120) | Biotronik, Inc. | 2023-04-04 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S379) | Medtronic Neuromodulation | 2023-04-04 |
| Straumann Emdogain (P930021/S028) | The Straumann Company | 2023-04-04 |
| SURGICEL® Absorbable Hemostats (SURGICEL® POWDER) (N12159/S101) | ETHICON, Inc. | 2023-04-04 |
| HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (P160029/S019) | Philips Medical Systems, Inc. | 2023-04-03 |
| VenaSeal Closure System (P140018/S033) | Medtronic Vascular, Inc. | 2023-04-03 |
| HeartStart FRx Defibrillator (P180028/S013) | Philips Medical Systems | 2023-04-03 |
| Alinity m CMV (P210022/S004) | Abbott Molecular, Inc. | 2023-03-31 |
| Impella RP Flex with SmartAssist (P170011/S048) | Abiomed, Inc. | 2023-03-31 |
| Alinity m HBV (P200013/S013) | Abbott Molecular, Inc. | 2023-03-31 |
| Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management (P210037) | Biotronik Nro, Inc. | 2023-03-31 |
| Masters HP Valved Graft with Gelweave Valsalva Technology (VAVGJ) (P810002/S118) | ABBOTT MEDICAL | 2023-03-31 |
| Belotero Balance Dermal Filler (P090016/S052) | Merz North America, Inc. | 2023-03-31 |
| NeuRX Diaphragm Pacing System (DPS) (P200018) | Synapse Biomedical, Inc. | 2023-03-31 |
| Light Adjustable Lens (LAL), Light Delivery Device (LDD) System (P160055/S024) | Rxsight, Inc. | 2023-03-31 |
| Edwards Commander Delivery System (P140031/S154) | Edwards Lifesciences, LLC | 2023-03-30 |
| Edwards Commander Delivery System (P200015/S036) | Edwards Lifesciences, LLC | 2023-03-30 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S032) | Smith & Nephew, Inc. | 2023-03-30 |
| MitraClip G4 Clip Delivery System, MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System (P100009/S053) | ABBOTT MEDICAL | 2023-03-30 |
| Eversense® E3 Continuous Glucose Monitoring (CGM) System (P160048/S022) | Senseonics, Incorporated | 2023-03-30 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S060) | Alcon Research, Ltd. | 2023-03-29 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S058) | Boston Scientific Corp | 2023-03-29 |
| Eversense® E3 Continuous Glucose Monitoring (CGM) System (P160048/S021) | Senseonics, Incorporated | 2023-03-29 |
| Impella Ventricular Support Systems (P140003/S107) | Abiomed, Inc. | 2023-03-29 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System (P840064/S079) | Alcon Laboratories | 2023-03-29 |
| Prismaflex TPE2000 (P830063/S025) | Vantive US Healthcare, LLC | 2023-03-29 |
| remede® System (P160039/S008) | Respicardia | 2023-03-28 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S214) | Medtronic Cardiac Rhythm Disease Management | 2023-03-28 |
| CapSure SP Novus Lead, Vitatron Impulse II Lead (P850089/S164) | Medtronic Cardiac Rhythm Disease Management | 2023-03-28 |
| SelectSecure Lead (P030036/S142) | Medtronic Cardiac Rhythm Disease Management | 2023-03-28 |
| Epic Max Tissue Heart Valves (P040021/S052) | ABBOTT MEDICAL | 2023-03-28 |
| BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S117) | ABBOTT MEDICAL | 2023-03-28 |
| Amplatzer Piccolo Occluder (P020024/S067) | ABBOTT MEDICAL | 2023-03-27 |
| T-SPOT ®.TB (P070006/S019) | Oxford Immunotec, Ltd. | 2023-03-27 |
| Zephyr Valve Reigstry (ZEVR) (P180002/S022) | Pulmonx Corporation | 2023-03-25 |
| Pedi-padz Multifunction Electrodes, Pro-padz Cardiology W/LVP Gel Electrodes, Pro-padz Radiolucent Liquid Gel Electrodes (P160022/S033) | ZOLL Medical Corporation | 2023-03-24 |
| 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/S816) | Medtronic Cardiac Rhythm Disease Management | 2023-03-24 |
| RangerOver-The-Wire Paclitaxel-Coated PTA Balloon Catheter (P190019/S011) | Boston Scientific Corporation | 2023-03-24 |
| NexGen® LPS-Flex / LPS-Mobile Bearing Knee (P060037/S084) | Zimmer, Inc. | 2023-03-24 |
| 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/S851) | Medtronic Cardiac Rhythm Disease Management | 2023-03-24 |
| AtriCure Isolator Clamp, AtriCure Long Clamp, AtriCure Synergy Clamp (P100046/S015) | AtriCure, Inc. | 2023-03-23 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems, Onyx Frontier Zotarolimus-Eluting Coronary Stent Systems (P160043/S065) | Medtronic Vascular | 2023-03-23 |
| Calcivis Imaging System (P170029/S001) | Calcivis Limited | 2023-03-23 |
| ActaStim-S Non Invasive Spine Fusion Stimulator (P190030/S002) | Theragen, Inc. | 2023-03-23 |
| Elecsys total PSA, total PSA CalSet II (P990056/S039) | Roche Diagnostics Corp. | 2023-03-23 |
| Elecsys free PSA, free PSA CalSet (P000027/S037) | Roche Diagnostics Corp. | 2023-03-23 |
| Powerheart G5 AED (P160033/S009) | ZOLL Medical Corporation | 2023-03-23 |
| Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert (P160048/S023) | Senseonics, Incorporated | 2023-03-22 |
| MiSight 1 Day (omafilcon A) (P180035/S016) | CooperVision, Inc. | 2023-03-22 |