| BD Onclarity HPV Assay (P160037/S023) | Becton, Dickinson and Company | 2025-07-02 |
| Oncomine Dx Express Test (P240040) | Life Technologies Corporation | 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 |
| SIR-Spheres Y-90 resin microspheres (P990065/S014) | Sirtex Medical, Inc. | 2025-07-01 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone (N970012/S208) | Boston Scientific Corp | 2025-07-01 |
| HeartMate 3 Left Ventricular Assist System (P160054/S107) | ABBOTT MEDICAL | 2025-07-01 |
| Organ Care System (OCS) Liver (P200031/S010) | TransMedics, Inc. | 2025-07-01 |
| OrganOx metra System (P200035/S024) | Organox Limited | 2025-07-01 |
| LIFEPAK FLEX Lithium-ion Battery (P160026/S061) | Physio-Control, Inc. | 2025-06-30 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| THERAKOS® CELLEX® Photopheresis System Procedural Kit (P860003/S113) | Therakos Development Limited | 2025-06-30 |
| Nevro Corp Senza Spinal Cord Stimulation (SCS) System (P130022/S061) | Nevro Corporation | 2025-06-30 |
| xT CDx (P210011/S003) | Tempus AI, Inc. | 2025-06-27 |
| PD-L1 IHC 28-8 pharmDx (P150025/S017) | Agilent Technologies, Inc. | 2025-06-27 |
| 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 |
| MAGE-A4 IHC 1F9 pharmDx (P230016/S002) | Agilent Technologies, 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 |
| PD-L1 IHC 22C3 PHARMDX (P150013/S030) | Agilent Technologies, Inc. | 2025-06-27 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (P050052/S170) | Merz North America, Inc. | 2025-06-26 |
| 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 |
| RADIESSE® Injectable Implant (P050037/S146) | Merz North America, Inc. | 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 |
| Juvederm Injectable Gel (P110033/S085) | Allergan | 2025-06-25 |
| Total Artificial Heart (P030011/S081) | Syncardia Systems, LLC | 2025-06-25 |
| Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management (P210037/S011) | Biotronik Nro, Inc. | 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 |
| VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM (P150031/S086) | Boston Scientific Corp | 2025-06-25 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S384) | Boston Scientific Corp | 2025-06-25 |
| Altius Direct Electrical Nerve Stimulation System (P230020/S003) | Neuros Medical, Inc. | 2025-06-25 |
| CERAMAX® ceramic total hip system (P070026/S120) | DePuy Orthopaedics, Inc. | 2025-06-24 |
| LCS® Total Knee System (P830055/S345) | Depuy, Inc. | 2025-06-24 |
| OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S110) | Biomet Manufacturing Corp | 2025-06-24 |
| Neuroform Atlas® Stent System (P180031/S006) | Stryker Neurovascular | 2025-06-24 |
| Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S119) | ABBOTT MEDICAL | 2025-06-24 |
| Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S238) | ABBOTT MEDICAL | 2025-06-24 |
| comfilcon A Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S189) | CooperVision, Inc. | 2025-06-23 |
| 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 |
| Optilume Urethral Drug Coated Balloon Catheter (P210020/S010) | Urotronic, 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 |
| VENTANA MMR RxDx Panel (P200019/S012) | Ventana Medical Systems | 2025-06-20 |
| VENTANA MET (SP44) RxDx Assay (P240037/S002) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2025-06-20 |
| 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 |
| VENTANA CLDN18 (43-14A) RxDx Assay (P230018/S001) | Ventana Medical Systems, Inc. | 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 |
| PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S057) | Ventana Medical Systems, Inc. | 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 |
| ReActiv8 Implantable Neurostimulation System (P190021/S009) | Mainstay Medical Limited | 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 |
| VENTANA ALK (D5F3) CDX ASSAY (P140025/S025) | Ventana Medical Systems, 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 |
| VENTANA PD-L1 (SP263) ASSAY (P160046/S020) | Ventana Medical Systems, Inc. | 2025-06-20 |
| VENTANA FOLR1 (FOLR-2.1) RxDx Assay (P220006/S007) | Ventana Medical Systems, Inc. | 2025-06-20 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S019) | ABBOTT MEDICAL | 2025-06-20 |
| Transcend® Hip Articulation System (P010001/S031) | Ceramtec GmbH | 2025-06-20 |
| PATHWAY® Anti-c-KIT (9.7) Primary Antibody (P020055/S032) | Ventana Medical Systems, Inc. | 2025-06-20 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lenses (P190018/S039) | Alcon Laboratories, LLC | 2025-06-18 |
| 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 |
| Inspire® Upper Airway Stimulation (UAS) (P130008/S126) | Inspire Medical Systems | 2025-06-18 |
| Aveir LSP112V, LSP201A, LSP202V (P150035/S027) | ABBOTT MEDICAL | 2025-06-18 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S320) | Medtronic Neuromodulation | 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 |
| PearlMatrix Bone Graft (P240001) | Cerapedics, Inc. | 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 |