| cobas® EZH2 Mutation Test (P200014/S010) | Roche Molecular System, Inc. | 2025-12-31 |
| cobas® HPV (P190028/S022) | Roche Molecular Systems, Inc. | 2025-12-31 |
| cobas® EGFR Mutation Test, v2.0 (P120019/S042) | Roche | 2025-12-31 |
| cobsa® BRAF V600 Mutation Test (P110020/S043) | Roche Molecular Systems, Inc. | 2025-12-31 |
| cobas® KRAS Mutation Test (P140023/S031) | Roche Molecular Systems, Inc. | 2025-12-31 |
| cobas® HPV (P100020/S064) | Roche Molecular Systems, Inc. | 2025-12-31 |
| ProlivRx System (P250010) | Neurolief , Ltd. | 2025-12-31 |
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| OneStep CPR Complete Electrode (P160022/S049) | ZOLL Medical Corporation | 2025-12-30 |
| Guardant360 CDx (P200010/S028) | Guardant Health, Inc. | 2025-12-29 |
| Proclaim Dorsal Root Ganglion (DRG) System (P150004/S092) | ABBOTT MEDICAL | 2025-12-23 |
| TRUPULSE Generator (P240006/S012) | Biosense Webster, Inc. | 2025-12-23 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S033) | CooperVision, Inc. | 2025-12-23 |
| DETOUR System (P220021/S008) | Endologix, LLC | 2025-12-23 |
| Gambro Prismaflex TPE 2000 Set (P830063/S031) | Vantive US Healthcare, LLC | 2025-12-23 |
| Proclaim Spinal Cord Stimulation (SCS) System (P010032/S246) | ABBOTT MEDICAL | 2025-12-23 |
| DUROLANE (P170007/S015) | Bioventus, LLC | 2025-12-23 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S096) | St Jude Medical | 2025-12-23 |
| InterStim Therapy System, Verify Evaluation System (P080025/S337) | Medtronic Neuromodulation | 2025-12-23 |
| Restylane® Lyft with Lidocaine (P040024/S146) | Q-Med AB | 2025-12-23 |
| nGEN Pump (P990071/S068) | Biosense Webster, Inc. | 2025-12-23 |
| Infinity Deep Brain Stimulation (DBS) System (P140009/S127) | ABBOTT MEDICAL | 2025-12-23 |
| C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) (P060011/S043) | Rayner Intraocular Lenses , Ltd. | 2025-12-23 |
| InterStim Therapy System, Verify Evaluation System (P970004/S442) | Medtronic Neuromodulation | 2025-12-23 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S014) | ABBOTT MEDICAL | 2025-12-23 |
| SYNOJOYNT (P170016/S001) | Mesoblast | 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 |
| Master Restore; Itrel; Synergy; Intellis; Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces; Specify; and Ve (P840001/S616) | Medtronic Neuromodulation | 2025-12-22 |
| Revanesse Versa; Revanesse Versa+ (with lidocaine); Revanesse Lips+ (with lidocaine) (P160042/S029) | Prollenium Medical Technologies, Inc. | 2025-12-22 |
| Perceval Sutureless Heart Valve (P150011/S035) | Corcym S.r.l. | 2025-12-22 |
| InterStim Therapy System; Verify Evaluation System (P970004/S441) | Medtronic Neuromodulation | 2025-12-22 |
| iCast Covered Stent System (P120003/S009) | Atrium Medical Corp. | 2025-12-22 |
| InterStim Therapy System; Verify Evaluation System (P080025/S336) | Medtronic Neuromodulation | 2025-12-22 |
| SynchroMed Infusion System; Ascenda Intrathecal Catheters (P860004/S455) | Medtronic, Inc. | 2025-12-22 |
| ADATO SIL-OL 5000 Silicone Oils (P910071/S019) | Bausch & Lomb | 2025-12-22 |
| Shield (P230009/S011) | Guardant Health, Inc. | 2025-12-22 |
| Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (P960009/S527) | Medtronic, Inc. | 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 |
| LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S008) | DiaSorin, 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 |
| Axonics Sacral Neuromodulation System (P190006/S101) | Boston Scientific Corporation | 2025-12-19 |
| GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder (P050006/S116) | W. L. Gore & Associates, Inc. | 2025-12-19 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S240) | Cochlear Americas | 2025-12-19 |
| SynchroMed Infusion Systems (P860004/S453) | Medtronic, 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 |
| SUPARTZ FX; VISCO-3 (P980044/S065) | Seikagaku Corp. | 2025-12-19 |
| alfapump System (P230044/S002) | Sequana Medical NV | 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 |
| Medtronic Altaviva System (P240011/S004) | Medtronic Neuromodulation | 2025-12-19 |
| Axonics Sacral Neuromodulation System (P180046/S101) | Boston Scientific Corporation | 2025-12-19 |
| LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus (P180047/S041) | DiaSorin, Inc. | 2025-12-19 |
| Evolysse Injectable Hyaluronic Acid (P240022/S004) | Symatese | 2025-12-19 |
| Minima Stent System (P240003/S005) | Renata Medical, Inc. | 2025-12-18 |
| GlideLight Laser Sheath (P960042/S073) | Spectranetics (Philips) | 2025-12-18 |
| WaveWriter Alpha Spinal Cord Stimulator (SCS) Mixed Systems, M8 Adaptor (P030017/S374) | Boston Scientific Corp | 2025-12-18 |
| Barricaid® Annular Closure Device (P160050/S011) | Intrinsic Therapeutics | 2025-12-18 |
| VisuMax; VISUMAX 800 (P150040/S020) | Carl Zeiss Meditec, Inc. | 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 |
| Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vec (P840001/S614) | Medtronic Neuromodulation | 2025-12-18 |
| AED 3 (P160015/S025) | ZOLL Medical Corporation | 2025-12-18 |
| TRIDYNE Vascular Sealant (P150016/S027) | Neomend, Inc. | 2025-12-18 |
| Evolysse® FORM (P240022/S003) | Symatese | 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 |
| Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (P960009/S526) | Medtronic, Inc. | 2025-12-18 |
| Cerene® Cryotherapy Device (P180032/S022) | Channel Medsystems, Inc. | 2025-12-18 |
| PROGEL Pleural Air Leak Sealant (P010047/S072) | Neomend, Inc. | 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 |
| MiniMed 670G System (P160017/S133) | Medtronic Minimed, Inc. | 2025-12-18 |
| ATTUNE Revision Rotating Platform (RP) Knee System (P830055/S346) | Depuy, Inc. | 2025-12-18 |
| OrganOx metra® System (P200035/S031) | Organox Limited | 2025-12-17 |
| MENTOR MemoryShape Breast Implants (P060028/S057) | Mentor Worldwide, LLC | 2025-12-17 |
| Motiva SmoothSilk®Round; Round Ergonomix® Silicone Gel-Filled Breast Implants (P230005/S003) | Motiva USA, LLC | 2025-12-17 |
| 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 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S090) | Boston Scientific Corp | 2025-12-17 |
| ALTRUA 2 (Model S722); ESSENTIO (Model L121); PROPONENT (Model L221); ACCOLADE (Model L321) (N970003/S305) | Boston Scientific Corp | 2025-12-17 |
| TOUCH® CMC 1 Prosthesis (P240020/S003) | Keri Medical SA | 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 |
| Activa Deep Brain Stimulation Therapy System (P960009/S514) | Medtronic, Inc. | 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 |