| ESSENTIO MRI (Models L110, L111, L131); PROPONENT MRI (Models L210, L211, L231); ACCOLADE MRI (Models L310, L311, L33 (P150012/S168) | Boston Scientific | 2025-07-11 |
| AED Plus and Fully Automatic AED Plus (P160015/S021) | ZOLL Medical Corporation | 2025-07-11 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S108) | ABBOTT MEDICAL | 2025-07-11 |
| X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower (P160022/S043) | ZOLL Medical Corporation | 2025-07-11 |
| EXOSEAL Vascular Closure Device (P100013/S031) | Cordis US Corporation | 2025-07-11 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S041) | Medtronic Vascular, Inc. | 2025-07-10 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S057) | Biotronik AG | 2025-07-10 |
| EndoForce Connector for Endovascular Venous Anastomosis (P240004/S002) | Phraxis, Inc. | 2025-07-10 |
| Astron Pulsar; Pulsar-18; Pulsar-18 T3 (P160025/S020) | Biotronik AG | 2025-07-10 |
| Astron (P140030/S018) | Biotronik AG | 2025-07-10 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S025) | Biotronik AG | 2025-07-10 |
| Preveleak Surgical Sealant (P100030/S021) | Baxter Healthcare Corporation | 2025-07-10 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C (P140010/S094) | Medtronic, Inc. | 2025-07-10 |
| Cobalt MRI ICD, Cobalt XT MRI ICD (P980016/S929) | Medtronic Cardiac Rhythm Disease Management | 2025-07-09 |
| HeartWare HVAD System (P100047/S227) | Medtronic | 2025-07-09 |
| Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4, Brava CRT-D DTBC1D1; Bra (P010031/S892) | Medtronic Cardiac Rhythm Disease Management | 2025-07-09 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S895) | Medtronic Cardiac Rhythm Disease Management | 2025-07-09 |
| LimFlow System (P220025/S006) | LimFlow, Inc. | 2025-07-09 |
| Epsila EV Extravascular Lead EV2401 (P220012/S053) | Medtronic, Inc. | 2025-07-09 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S042) | Medtronic Vascular, Inc. | 2025-07-09 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitax (P140010/S095) | Medtronic, Inc. | 2025-07-09 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S040) | Medtronic Vascular, Inc. | 2025-07-09 |
| Sprint Quattro Lead 6935M, Sprint Quattro Lead 6946M, Sprint Quattro Lead 6947, Sprint Quattro Lead 6947M, Sprint Quattr (P920015/S300) | Medtronic, Inc. | 2025-07-09 |
| Micra AV TPS MC1lAVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS MC2VR01 (P150033/S211) | Medtronic, Inc. | 2025-07-09 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S093) | Medtronic, Inc. | 2025-07-09 |
| Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D (P980016/S926) | Medtronic Cardiac Rhythm Disease Management | 2025-07-09 |
| Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29) (P200015/S067) | Edwards Lifesciences, LLC | 2025-07-08 |
| Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29, 9750CM20, 9750CM23, 9750CM26) (P140031/S191) | Edwards Lifesciences, LLC | 2025-07-08 |
| Sphere-9 Catheter and Affera Ablation System (P240013/S011) | Medtronic, Inc. | 2025-07-07 |
| iCast Covered Stent System (P120003/S006) | Atrium Medical Corp. | 2025-07-07 |
| Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E (P160032/S013) | Defibtech, LLC | 2025-07-03 |
| FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARAWAVE NAV Pulsed Field Ablation C (P230030/S007) | Farapulse, Inc. | 2025-07-03 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S058) | Medinol, Ltd. | 2025-07-03 |
| Zilver® PTX® Peripheral Drug-Eluting Stent (P100022/S044) | Cook Ireland, Ltd. | 2025-07-03 |
| MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S210) | Medtronic, Inc. | 2025-07-02 |
| RX HERCULINK ELITE RENAL STENT SYSTEM (P110001/S021) | Abbott Vascular | 2025-07-02 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S816) | Medtronic, Inc. | 2025-07-02 |
| Aurora EV-ICD System (P220012/S052) | Medtronic, Inc. | 2025-07-02 |
| Aveir VR and DR Delivery Catheters (P150035/S024) | ABBOTT MEDICAL | 2025-07-02 |
| MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015/S566) | Medtronic, Inc. | 2025-07-02 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S894) | Medtronic Cardiac Rhythm Disease Management | 2025-07-02 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S928) | Medtronic Cardiac Rhythm Disease Management | 2025-07-02 |
| Zilver Flex(R) 35 Vascular Stent (P050017/S024) | Cook Ireland, Ltd. | 2025-07-01 |
| HeartMate 3 Left Ventricular Assist System (P160054/S107) | ABBOTT MEDICAL | 2025-07-01 |
| LIFEPAK FLEX Lithium-ion Battery (P160026/S061) | Physio-Control, Inc. | 2025-06-30 |
| CapSureFix Novus Lead; Vitatron Crystalline Active Fixation Lead (P930039/S272) | Medtronic, Inc. | 2025-06-27 |
| SelectSecure Lead (P030036/S153) | Medtronic Cardiac Rhythm Disease Management | 2025-06-27 |
| PulseSelect Pulsed Field Ablation (PFA) system (P230017/S007) | Medtronic, Inc. | 2025-06-27 |
| Shockwave Intravascular Lithotripsy (IVL) 825 Series Generators (P200039/S017) | Shockwave Medical, Inc. | 2025-06-27 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S011) | ABBOTT MEDICAL | 2025-06-27 |
| Sphere-9 Catheter and Affera Ablation System (P240013/S009) | Medtronic, Inc. | 2025-06-26 |
| Avalus Bioprosthesis, Model 400 (P170006/S037) | Medtronic, Inc. | 2025-06-26 |
| EverFlex Self-expanding Peripheral Stent with Entrust Delivery System (P110023/S059) | Medtronic Vascular, Inc. | 2025-06-26 |
| Covera Vascular Covered Stents (P170042/S013) | C.R. Bard, Inc. | 2025-06-26 |
| Edwards Commander Delivery System (P200015/S066) | Edwards Lifesciences, LLC | 2025-06-26 |
| Resolute Onyx (P160043/S088) | Medtronic Vascular | 2025-06-26 |
| Avalus Bioprosthesis, Model 400 (P170006/S036) | Medtronic, Inc. | 2025-06-26 |
| BioMimics 3D Vascular Stent System (P180003/S012) | Veryan Medical, Ltd. | 2025-06-26 |
| Freestyle Bioprosthesis, Models 995, 995CS, 995MS (P970031/S075) | Medtronic, Inc. | 2025-06-26 |
| Mosaic Bioprosthesis, Models 305, 310 (P990064/S092) | Medtronic, Inc. | 2025-06-26 |
| VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump) (P240006/S007) | Biosense Webster, Inc. | 2025-06-26 |
| HeartWare Ventricular Assist System (HVAD) (P100047/S230) | Medtronic | 2025-06-26 |
| Edwards Commander Delivery System (P140031/S190) | Edwards Lifesciences, LLC | 2025-06-26 |
| Hancock II Bioprosthesis, Models T505, T510 (P980043/S083) | Medtronic, Inc. | 2025-06-26 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S038) | Boston Scientific Corporation | 2025-06-26 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S011) | Endotronix, Inc. | 2025-06-25 |
| Total Artificial Heart (P030011/S081) | Syncardia Systems, LLC | 2025-06-25 |
| TriClip G4 Delivery System; MitraClip G5 Delivery System, TriClip G5 Delivery System (P230007/S013) | ABBOTT MEDICAL | 2025-06-25 |
| MitraClip G4 Clip Delivery System; MitraClip NTR Clip Delivery System; MitraClip XTR Clip Delivery System (P100009/S075) | ABBOTT MEDICAL | 2025-06-25 |
| Roadsaver/CASPER Carotid Stent Device (P210030/S001) | MicroVention, Inc. | 2025-06-23 |
| CGuard Prime Carotid Stent System (P240029) | InspireMD, Ltd. | 2025-06-23 |
| Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist (P170011/S057) | Abiomed, Inc. | 2025-06-23 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD (P140003/S125) | Abiomed, Inc. | 2025-06-23 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S012) | Endotronix, Inc. | 2025-06-20 |
| HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (P160029/S028) | Philips Medical Systems, Inc. | 2025-06-20 |
| AED Plus and Fully Automatic AED Plus (P160015/S018) | ZOLL Medical Corporation | 2025-06-20 |
| IMPELLA CP with Smart Assist (P140003/S127) | Abiomed, Inc. | 2025-06-20 |
| X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower (P160022/S040) | ZOLL Medical Corporation | 2025-06-20 |
| CapSure Sense Lead (P830061/S231) | Medtronic Cardiac Rhythm Disease Management | 2025-06-20 |
| CapSureFix Novus Lead (P930039/S271) | Medtronic, Inc. | 2025-06-20 |
| LIFEPAK® CR2 Defibrillator (P170018/S022) | Physio-Control, Inc. | 2025-06-20 |
| 2292 Analyzer Cable (P890003/S478) | Medtronic, Inc. | 2025-06-20 |
| LIFEPAK 35 monitor/defibrillator (P160026/S059) | Physio-Control, Inc. | 2025-06-20 |
| TherOx Downstream Cartridge (P170027/S019) | Zoll Circulation, Inc. | 2025-06-20 |
| LIFEPAK 15 monitor/defibrillator; LIFEPAK 35 monitor/defibrillator; LIFEPAK 20e defibrillator/monitor; LIFEPAK 1000 defi (P160026/S060) | Physio-Control, Inc. | 2025-06-20 |
| Adapta, Versa, Sensia IPG (P980035/S814) | Medtronic, Inc. | 2025-06-20 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S094) | St Jude Medical | 2025-06-20 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S019) | ABBOTT MEDICAL | 2025-06-20 |
| Micra AV TPS MC1AVR1, Micra AV2 TPS MC2AVR1, Micra TPS MC1VR01, Micra VR2 TPS MC2VR01 (P150033/S209) | Medtronic, Inc. | 2025-06-18 |
| Allure PM3120; Allure Quadra RF PM3242; Allure Quadra PM3140; Allure RF PM3222; Anthem PM3210; Quadra Allure PM3542; (P030035/S210) | ABBOTT MEDICAL | 2025-06-18 |
| WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System (P240028/S001) | EBR Systems, Inc. | 2025-06-18 |
| Aveir LSP112V, LSP201A, LSP202V (P150035/S027) | ABBOTT MEDICAL | 2025-06-18 |
| Gallant DR CDDRA500Q; Gallant VR CDVRA500Q; Neutrino NxT DR CDDRA800Q; Neutrino NxT DR CDDRA600Q; Neutrino NxT VR CDVRA8 (P910023/S480) | ABBOTT MEDICAL | 2025-06-18 |
| Acticor 7 VR-T 429526, Rivacor 7 VR-T 429536, Rivacor 5 VR-T 429565, Rivacor 3 VR-T 429574, Acticor 7 VR-T DX 429525, Ri (P050023/S198) | Biotronik, Inc. | 2025-06-18 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S815) | Medtronic, Inc. | 2025-06-18 |
| IsoFlex Optim Lead 1944, 1948 (P960030/S082) | ABBOTT MEDICAL | 2025-06-18 |
| Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR- (P950037/S273) | Biotronik, Inc. | 2025-06-18 |
| TRIDYNE Vascular Sealant (P150016/S026) | Neomend, Inc. | 2025-06-18 |
| SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 (P890003/S479) | Medtronic, Inc. | 2025-06-18 |
| Cobalt MRI ICD DDPB3D1, DDPB3D4; Cobalt MRI ICD DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1, DVPA2D4; Cobalt XT (P980016/S927) | Medtronic Cardiac Rhythm Disease Management | 2025-06-18 |