| OneStep CPR Complete Electrode (P160022/S049) | ZOLL Medical Corporation | 2025-12-30 |
| TRUPULSE Generator (P240006/S012) | Biosense Webster, Inc. | 2025-12-23 |
| DETOUR System (P220021/S008) | Endologix, LLC | 2025-12-23 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S096) | St Jude Medical | 2025-12-23 |
| nGEN Pump (P990071/S068) | Biosense Webster, Inc. | 2025-12-23 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S014) | ABBOTT MEDICAL | 2025-12-23 |
| SAPIEN M3 Transcatheter Mitral Valve Replacement System (P250019) | Edwards Lifesciences, LLC | 2025-12-22 |
| samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories (P160008/S031) | Heartsine Technologies, Ltd. | 2025-12-22 |
| Perceval Sutureless Heart Valve (P150011/S035) | Corcym S.r.l. | 2025-12-22 |
| iCast Covered Stent System (P120003/S009) | Atrium Medical Corp. | 2025-12-22 |
| Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (P010015/S574) | Medtronic, Inc. | 2025-12-19 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S055) | Berlin Heart, Inc. | 2025-12-19 |
| GORE® VIABAHN® FORTEGRA Venous Stent (P250017) | W. L. Gore & Associates, Inc. | 2025-12-19 |
| Cool Point Tubing Set (P060019/S058) | Irvine Biomedical, Inc. | 2025-12-19 |
| Cobalt MRI CRT-D DTPB2D1, DTPB2D4 NIK Cobalt XT MRI CRT-D DTPA2D1, DTPA2D4 NIK Crome MRI CRT-D DTPC2D1, DTPC2D4 (P010031/S905) | Medtronic Cardiac Rhythm Disease Management | 2025-12-19 |
| GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder (P050006/S116) | W. L. Gore & Associates, Inc. | 2025-12-19 |
| Impella CP with SmartAssist; Impella 5.5 with SmartAssist (P140003/S136) | Abiomed, Inc. | 2025-12-19 |
| CorPASS System (P230040/S015) | Endotronix, Inc. | 2025-12-19 |
| Impella CP with SmartAssist; Impella 5.5 with SmartAssist (P170011/S062) | Abiomed, Inc. | 2025-12-19 |
| VALITUDE (Model U125) VALITUDE X4 (Model U128) VISIONIST (Models U225, U226) VISIONIST X4 (Model U228) Firmware Vers (P030005/S250) | Guidant Corp. | 2025-12-19 |
| HeartSync Multifunction Disposable Single-Use Defibrillator Pads (P200007/S002) | Graphic Controls D.B.A. Vermed | 2025-12-19 |
| ALTRUA 2 (Models S701, S702, S722) ESSENTIO (Models L100, L101, L121) PROPONENT (Models L200, L201, L221) ACCOLADE ( (N970003/S304) | Boston Scientific Corp | 2025-12-19 |
| ESSENTIO MRI (Models L110, L111, L131) PROPONENT MRI (Models L210, L211, L231) ACCOLADE MRI (Models L310, L311, L331) (P150012/S173) | Boston Scientific | 2025-12-19 |
| Volt PFA System (P250022) | ABBOTT MEDICAL | 2025-12-19 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S089) | Medtronic Vascular | 2025-12-19 |
| Minima Stent System (P240003/S005) | Renata Medical, Inc. | 2025-12-18 |
| GlideLight Laser Sheath (P960042/S073) | Spectranetics (Philips) | 2025-12-18 |
| Acticor Sky DR-T 481987, Rivacor Sky DR-T 481982, Rivacor Rise DR-T 482018, Rivacor Aura DR-T 482014 (P000009/S120) | Biotronik, Inc. | 2025-12-18 |
| Occlutech ASD Occluder; Occlutech Pistol Pusher (OPP); Occlutech ASD Occluder Procedure Pack (P200032/S004) | Occlutech Holding AG | 2025-12-18 |
| Acticor Sky VR-T 481989, Rivacor Sky VR-T 481984, Rivacor Rise VR-T 482020, Rivacor Aura VR-T 482015, Acticor Sky VR-T D (P980023/S136) | Biotronik, Inc. | 2025-12-18 |
| Solia S 53 377177; Solia S 60 377179 (P950037/S274) | Biotronik, Inc. | 2025-12-18 |
| AED 3 (P160015/S025) | ZOLL Medical Corporation | 2025-12-18 |
| TRIDYNE Vascular Sealant (P150016/S027) | Neomend, Inc. | 2025-12-18 |
| X Series®; Propaq MD®; AED 3 BLS; Zenix Professional Defibrillators (P160022/S046) | ZOLL Medical Corporation | 2025-12-18 |
| Acticor Sky HF-T 481986, Rivacor Sky HF-T 481991, Rivacor Rise HF-T 482017, Rivacor Aura HF-T 482013, Acticor Sky HF-T Q (P050023/S199) | Biotronik, Inc. | 2025-12-18 |
| ELCA Coronary Atherectomy Catheters (P910001/S125) | Spectranetics Corp. | 2025-12-18 |
| CELT ACD Vascular Closure Device (P150006/S007) | Vasorum, Ltd. | 2025-12-18 |
| Coseal Applicator Tips (P030039/S032) | Baxter Bio Science | 2025-12-18 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S082) | Boston Scientific Corp | 2025-12-18 |
| ESSENTIO MRI (Model L131); PROPONENT MRI (Model L231); ACCOLADE MRI (Model L331) (P150012/S175) | Boston Scientific | 2025-12-17 |
| Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, Models 9755RSL20, 9755RSL23, 9755RSL26, and 9755RSL29 (P140031/S197) | Edwards Lifesciences, LLC | 2025-12-17 |
| SynCardia Total Artificial Heart (STAH) system (P030011/S096) | Syncardia Systems, LLC | 2025-12-17 |
| ALTRUA 2 (Model S722); ESSENTIO (Model L121); PROPONENT (Model L221); ACCOLADE (Model L321) (N970003/S305) | Boston Scientific Corp | 2025-12-17 |
| Edwards INSPIRIS RESILIA Aortic Valve, Model 11500A, Sizes 19mm, 21mm, 23mm, 25mm, 27mm, and 29mm; Edwards KONECT RESILI (P150048/S095) | Edwards Lifesciences, LLC | 2025-12-17 |
| VALITUDE (Model U125); VALITUDE X4 (Model U128); VISIONIST (Models U225, U226); VISIONIST X4 (Model U228) (P030005/S251) | Guidant Corp. | 2025-12-17 |
| Embrace Hydrogel Embolic System (HES) (P250003/S002) | Instylla, Inc. | 2025-12-17 |
| HeartMate II Left Ventricular Assist System (P060040/S122) | ABBOTT MEDICAL | 2025-12-17 |
| Astron (P140030/S022) | Biotronik AG | 2025-12-17 |
| Astron Pulsar; Pulsar-18; Pulsar-18 T3 (P160025/S023) | Biotronik AG | 2025-12-17 |
| Carbomedics Prosthetic Heart Valve; Carbomedics® Supra-annular Prosthetic Heart Valve; Carbo-Seal® Ascending Aortic Pros (P900060/S069) | Corcym S.r.l. | 2025-12-17 |
| On-X Ascending Aortic Prosthesis (P000037/S067) | On-X Life Technologies, Inc. | 2025-12-17 |
| HeartMate 3 Left Ventricular Assist System (P160054/S116) | ABBOTT MEDICAL | 2025-12-17 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (sizes 20mm, 23mm, 26mm) 9750TFX; Edwards SAPIEN 3 Ultra RESILIA Transc (P140031/S196) | Edwards Lifesciences, LLC | 2025-12-17 |
| Organ Care System (OCS) Heart (P180051/S009) | TransMedics, Inc. | 2025-12-16 |
| Covera Vascular Covered Stent (P170042/S014) | C.R. Bard, Inc. | 2025-12-16 |
| Protégé GPS Self-expanding Peripheral Stent System (P060001/S053) | Medtronic Vascular, Inc. | 2025-12-16 |
| LifeStent® Vascular Stent Systems (P070014/S066) | Bard Peripheral Vascular, Inc. | 2025-12-16 |
| WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System (P240028/S004) | EBR Systems, Inc. | 2025-12-15 |
| Cobalt MRI ICD DDPB3D4, DVPB3D4; Cobalt XT MRI ICD DDPA2D4, DVPA2D4; Crome MRI ICD DDPC3D4, DVPC3D4; Evera MRI DF-1 ICD (P980016/S942) | Medtronic Cardiac Rhythm Disease Management | 2025-12-15 |
| WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S079) | Boston Scientific Corp | 2025-12-15 |
| WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S078) | Boston Scientific Corp | 2025-12-15 |
| Aurora EV-ICD System (P220012/S061) | Medtronic, Inc. | 2025-12-15 |
| 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/S909) | Medtronic Cardiac Rhythm Disease Management | 2025-12-15 |
| Abre Venous Self-expanding Stent System (P200026/S015) | Medtronic Vascular, Inc. | 2025-12-12 |
| WATCHMAN FLX Left Atrial Appendage (LAA) Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage ( (P130013/S080) | Boston Scientific Corp | 2025-12-12 |
| MISAGO® RX Self-expanding Peripheral Stent (P140002/S031) | Terumo Medical Corporation | 2025-12-12 |
| LifeVest® Wearable Defibrillator (P010030/S198) | Zoll Manufacturing Corporation | 2025-12-11 |
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023/S004) | Merit Medical Systems, Inc. | 2025-12-11 |
| 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/S173) | Biotronik, Inc. | 2025-12-10 |
| 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/S281) | Biotronik, Inc. | 2025-12-10 |
| LifeVest® Wearable Defibrillator (P010030/S197) | Zoll Manufacturing Corporation | 2025-12-09 |
| Durata Leads; Optisure Leads (P950022/S151) | ABBOTT MEDICAL | 2025-12-09 |
| Supera Peripheral Stent System (P120020/S034) | Abbott Vascular (Idef Technologies Inc) | 2025-12-09 |
| ZOLL Zenix Monitor/Defibrillator; ZOLL Zenix Multi-function Cable; ZOLL Zenix CPR Complete Electrodes; ZOLL OneStep Paci (P160022/S048) | ZOLL Medical Corporation | 2025-12-09 |
| Tendril STS Leads; Ultipace Leads (P960013/S132) | ABBOTT MEDICAL | 2025-12-09 |
| StarClose SE® Vascular Surgical System (P050007/S047) | Abbott Vascular Devices | 2025-12-09 |
| Perclose ProGlide® Suture-Mediated Closure System; Prostar® XL Percutaneous Vascular Surgical System (P960043/S127) | Abbott Vascular, Inc. | 2025-12-09 |
| XACT® Carotid Stent System (P040038/S048) | Abbott Vascular, Inc. | 2025-12-09 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (P200030/S023) | W. L. Gore and Associates, Inc. | 2025-12-05 |
| Intellagen Irrigation Tubing Set (P150005/S090) | Boston Scientific Corp | 2025-12-05 |
| S.M.A.R.T. and S.M.A.R.T.® CONTROL® Vascular Stent Systems (P120002/S033) | Cordis US Corporation | 2025-12-04 |
| S.M.A.R.T.® CONTROL® Nitinol Stent System (P020036/S058) | Cordis US Corporation | 2025-12-04 |
| LIFEPAK® 35 Defibrillator/monitor (P160026/S063) | Physio-Control, Inc. | 2025-12-04 |
| Amplia MRI CRT-D DTMB1D1, DTMB1D4, Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ NIK Brava CRT-D DTBC1D1 KRG, NIK Brava CRT-D D (P010031/S908) | Medtronic Cardiac Rhythm Disease Management | 2025-12-03 |
| Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua (P010031/S910) | Medtronic Cardiac Rhythm Disease Management | 2025-12-03 |
| Micra AV TPS MC1AVR1 PNJ Micra AV2 TPS MC2AVR1 PNJ Micra TPS MC1VR01 PNJ Micra VR2 TPS MC2VR01 (P150033/S219) | Medtronic, Inc. | 2025-12-03 |
| Aurora EV ICD DVEA3E4 (P220012/S060) | Medtronic, Inc. | 2025-12-03 |
| CareLink SmartSync Device Manager Base 24970A (P890003/S483) | Medtronic, Inc. | 2025-12-03 |
| Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I (P980016/S943) | Medtronic Cardiac Rhythm Disease Management | 2025-12-03 |
| Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (P010015/S575) | Medtronic, Inc. | 2025-12-03 |
| Aurora EV ICD (DVEA3E4) (P220012/S062) | Medtronic, Inc. | 2025-12-03 |
| Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D (P010031/S907) | Medtronic Cardiac Rhythm Disease Management | 2025-12-03 |
| Adapta, Versa, Sensia IPG ADDR01, ADDRS1, ADSR03, SES01 LWP, NVZ Adapta, Versa, Sensia IPG SEDRL1 NVZ Adapta, Versa, Sen (P980035/S827) | Medtronic, Inc. | 2025-12-03 |
| Cobalt MRI ICD; Cobalt XT MRI ICD ; Crome MRI ICD (P980016/S940) | Medtronic Cardiac Rhythm Disease Management | 2025-12-03 |
| Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, VEDR01, ADDR03, ADSR03, ADDR01, ADSR06, ADSR01, ADVDD01, SEDR01, ADDR06, SESR0 (P980035/S826) | Medtronic, Inc. | 2025-12-03 |
| Cobalt MRI ICD DVPB3D1, DDPB3D1, DDPB3D4, DVPB3D4 LWS, NVZ Cobalt XT MRI ICD DVPA2D1, DVPA2D4, DDPA2D1, DDPA2D4 LWS, NVZ (P980016/S941) | Medtronic Cardiac Rhythm Disease Management | 2025-12-03 |
| Micra A V2 TPS (MC2AVR1); Micra VR2 TPS (MC2VR01) (P150033/S218) | Medtronic, Inc. | 2025-12-02 |
| CentriMag Circulatory Support System (P170038/S025) | Abbott | 2025-12-01 |
| WOLVERINE Coronary Cutting Balloon (P950020/S147) | Boston Scientific Corp | 2025-12-01 |
| ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS (P980049/S146) | MicroPort CRM USA, Inc. | 2025-11-25 |