| Conformable GORE® TAG® Thoracic Endoprosthesis (P040043/S142) | W. L. Gore & Associates, Inc. | 2025-06-05 |
| Ceramic TRANSCEND® Hip Articulation System (P010001/S030) | Ceramtec GmbH | 2025-06-05 |
| CraniSeal Dural Sealant (P220014/S007) | Pramand, LLC | 2025-06-04 |
| PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS (P220003/S022) | Edwards Lifesciences, LLC | 2025-06-04 |
| LIAISON MUREX Anti-HBc and LIAISON MUREX Control Anti-HBc (P180038/S024) | DiaSorin, Inc. | 2025-06-04 |
| Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29 (P200015/S063) | Edwards Lifesciences, LLC | 2025-06-04 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S228) | Medtronic | 2025-06-04 |
| HeartMate II Left Ventricular Assist System (P060040/S116) | ABBOTT MEDICAL | 2025-06-04 |
| ADVIA Centaur HBsAgII (HBsII) (P110041/S014) | Siemens Corp. | 2025-06-04 |
| HeartMate 3 Left Ventricular Assist System (P160054/S101) | ABBOTT MEDICAL | 2025-06-04 |
| Edwards Certitude Delivery System: 9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9630TA20, 9630TA23, 9630TA26, 9630TA29 Ed (P140031/S186) | Edwards Lifesciences, LLC | 2025-06-04 |
| LIAISON QuantiFERON -TB Gold Plus and LIAISON Control QuantiFERON -TB Gold Plus (P180047/S035) | DiaSorin, Inc. | 2025-06-04 |
| OmniaSecure MRI SureScan Lead Model 3930M (P240036/S001) | Medtronic, Inc. | 2025-06-04 |
| PRODISC -L TOTAL DISC REPLACEMENT DEVICE (P050010/S025) | Centinel Spine, LLC | 2025-06-04 |
| prodisc C, prodisc C Vivo, prodisc C Nova, prodisc C SK (P070001/S028) | Centinel Spine, LLC | 2025-06-04 |
| Optune Lua (P230042/S002) | Novocure, GmbH | 2025-06-04 |
| MI Cancer Seek (P240010/S003) | Caris Life Sciences | 2025-06-04 |
| Endotak Lead System (P910073/S181) | Boston Scientific | 2025-06-04 |
| EVOQUE Tricuspid Delivery System: 9850TDS EVOQUE dilator kit: 9850DK EVOQUE loading system: 9850LS (P230013/S012) | Edwards Lifesciences, LLC | 2025-06-04 |
| NAV 2 Quadpole LV Long Spiral; NAV 2 Quadpole LV Straight; NAV 2 Quadpole LV Short Spiral (P010012/S590) | Boston Scientific Corp | 2025-06-04 |
| SpineSeal Spine Sealant (P240027/S002) | Pramand, LLC | 2025-06-04 |
| Pipeline Flex Embolization Device (Pipeline Flex); Pipeline Flex Embolization Device with Shield Technology (Pipelin (P100018/S051) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2025-06-04 |
| Diamondback 360 Coronary Orbital Atherectomy System; Diamondback 360 Precision Coronary Orbital Atherectomy System (P130005/S047) | Cardiovascular Systems, Inc. | 2025-06-03 |
| AMS 800 Artificial Urinary Sphincter (AUS) with and without lnhibiZone (P000053/S137) | Boston Scientific Corp | 2025-06-03 |
| Exablate Model 4000 System Type 1.0 and 1.1 System (Exablate Neuro; Exablate Prime) (P150038/S039) | Insightec | 2025-06-03 |
| Inspire Upper Airway Stimulation (UAS) (P130008/S116) | Inspire Medical Systems | 2025-06-03 |
| CentriMag Circulatory Support System (P170038/S024) | Abbott | 2025-06-02 |
| Lava Liquid Embolic System (Lava LES) (P220020/S006) | Sirtex Medical, Inc. | 2025-06-02 |
| OrganOx metra® System (P200035/S019) | Organox Limited | 2025-06-02 |
| enVista hydrophobic acrylic intraocular lens (IOL), enVista toric hydrophobic acrylic intraocular lens (IOL), enVista As (P910056/S059) | Bausch & Lomb, Inc. | 2025-05-30 |
| Surpass Streamline Flow Diverter (P170024/S023) | Stryker Neurovascular | 2025-05-30 |
| Zenith® Iliac Branch (P020018/S064) | Cook, Inc. | 2025-05-30 |
| Scoreflex NC Scoring PTCA Catheter (P200041/S008) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-05-30 |
| Vivistim® System (P210007/S006) | Mobia Medical, Inc. | 2025-05-30 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030/S193) | Zoll Manufacturing Corporation | 2025-05-30 |
| Epsila EV Extravascular Lead (EV2401) (P220012/S050) | Medtronic, Inc. | 2025-05-30 |
| AED 3 Semi-Automatic, AED 3 Fully Automatic (P160015/S022) | ZOLL Medical Corporation | 2025-05-30 |
| Consulta CRT-P C4TR01, Percepta Bipolar CRT-P W1TR01, Percepta Quadripolar CRT-P W4TR01, Serena Bipolar CRTP W1TR02, Ser (P010015/S562) | Medtronic, Inc. | 2025-05-30 |
| INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S125) | Inspire Medical Systems | 2025-05-30 |
| Hydrus® Microstent (P170034/S015) | Alcon Research, LLC | 2025-05-30 |
| Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01 Astra S DR MRI IPG X3DR01 Astra S SR MRI IPG X3SR (P980035/S811) | Medtronic, Inc. | 2025-05-30 |
| enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL) (P240005/S004) | Bausch & Lomb, Inc. | 2025-05-30 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030/S191) | Zoll Manufacturing Corporation | 2025-05-30 |
| Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039/S016) | Shockwave Medical, Inc. | 2025-05-30 |
| Sphere-9 Catheter and Affera Ablation System (P240013/S007) | Medtronic, Inc. | 2025-05-30 |
| AED 3 BLS (P160022/S044) | ZOLL Medical Corporation | 2025-05-30 |
| HV Splitter/Adaptor kit (5019); Sprint Quattro Lead (6947M); Sprint Quattro Lead (6946M); Sprint Quattro Lead (6935M) (P920015/S299) | Medtronic, Inc. | 2025-05-30 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S057) | Medinol, Ltd. | 2025-05-30 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S039) | Medtronic Vascular, Inc. | 2025-05-29 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C (P140010/S092) | Medtronic, Inc. | 2025-05-29 |
| VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM (P150031/S085) | Boston Scientific Corp | 2025-05-29 |
| CraniSeal Dural Sealant (P220014/S006) | Pramand, LLC | 2025-05-29 |
| Intraocular Lenses (IOLs) in the DaisyWheel and TECNIS SIMPLICITY Delivery System (P980040/S173) | Johnson & Johnson Surgical Vision, Inc. | 2025-05-29 |
| Simplify® Cervical Artificial Disc (P200022/S017) | Nuvasive, Inc. | 2025-05-29 |
| TOPS System (P220002/S008) | Premia Spine, Ltd. | 2025-05-29 |
| Scoreflex NC Scoring PTCA Catheter (P200041/S007) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-05-29 |
| S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036/S055) | Cordis US Corporation | 2025-05-28 |
| VISTAKON® (senofilcon A) Brand Contact Lenses (P040045/S140) | Vistakon, Division of Johnson & Johnson Vision Car | 2025-05-28 |
| SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS (P120002/S030) | Cordis US Corporation | 2025-05-28 |
| ROTAPRO Rotational Atherectomy System (P900056/S220) | Boston Scientific Corp | 2025-05-28 |
| Titan Inflatable Penile Prosthesis (P000006/S070) | Coloplast Corp. | 2025-05-28 |
| Cobalt MRI CRT-D DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ; Cobalt XT MRI CRT-D DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ; Crome MRI C (P010031/S890) | Medtronic Cardiac Rhythm Disease Management | 2025-05-28 |
| Cobalt MRI ICD DVPB3D1, DVPB3D4; Cobalt MRI ICD DDPB3D1, DDPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1; Cobalt XT MRI ICD (P980016/S924) | Medtronic Cardiac Rhythm Disease Management | 2025-05-28 |
| IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF (P060019/S057) | Irvine Biomedical, Inc. | 2025-05-28 |
| AMS 700 Inflatable Penile Prosthesis without InhibiZone (N970012/S207) | Boston Scientific Corp | 2025-05-28 |
| AMS 800 Artificial Urinary Sphincter (AUS) (P000053/S139) | Boston Scientific Corp | 2025-05-28 |
| EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S041) | Ferring Pharmaceuticals, Inc. | 2025-05-28 |
| TRUFILL n-BCA Liquid Embolic System (LES) and Procedural Set (P990040/S035) | Cerenovus, Inc. | 2025-05-28 |
| ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S043) | Roche Diagnostics Corp. | 2025-05-27 |
| SURGIFOAM® Absorbable Gelatin Sponge (P990004/S074) | Ferrosan Meidcal Devices A/S | 2025-05-27 |
| ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S044) | Roche Diagnostics Corp. | 2025-05-27 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S066) | Nevro Corporation | 2025-05-27 |
| Saluda Medical Evoke SCS System (P190002/S037) | Saluda Medical Pty, Ltd. | 2025-05-27 |
| HeartMate 3 Left Ventricular Assist System (P160054/S100) | ABBOTT MEDICAL | 2025-05-23 |
| Trident Acetabular System: Trident Alumina Inserts (P000013/S026) | Howmedica Osteonics Corp. | 2025-05-23 |
| MEL 90 EXCIMER LASER SYSTEM (P060004/S009) | Carl Zeiss Meditec, Inc. | 2025-05-23 |
| Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact (P040029/S023) | Euclid Vision Corporation | 2025-05-23 |
| Tendyne Transcatheter Mitral Valve System (P240042) | ABBOTT MEDICAL | 2025-05-23 |
| Barostim System (P180050/S014) | Cvrx, Inc. | 2025-05-23 |
| HeartMate II Left Ventricular Assist System (P060040/S115) | ABBOTT MEDICAL | 2025-05-23 |
| Endurity MRI, Assurity MRI (P140033/S097) | ABBOTT MEDICAL | 2025-05-22 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBc II (P100031/S033) | Roche Diagnostics Corp. | 2025-05-22 |
| Tendril STS, Optisense (P960013/S128) | ABBOTT MEDICAL | 2025-05-22 |
| Durata, Optisure (P950022/S147) | ABBOTT MEDICAL | 2025-05-22 |
| Zephyr XL DR, Zephyr DR, Zephyr SR, Zephyr XL SR, Verity ADX XL VDR (P880086/S343) | ABBOTT MEDICAL | 2025-05-22 |
| Sphere-9 Ablation and Mapping Catheter - AFR-00001 (P240013/S006) | Medtronic, Inc. | 2025-05-22 |
| Avant HF, Avant HF, Gallant HF, Entrant HF, Quadra Assura MP, Quadra Assura, Unify Assura, Quartet, QuickFlex Micro (P030054/S434) | ABBOTT MEDICAL | 2025-05-22 |
| Bulkamid Urethral Bulking System (P170023/S021) | Boston Scientific Corporation | 2025-05-22 |
| IsoFlex (P960030/S079) | ABBOTT MEDICAL | 2025-05-22 |
| Avant VR, Avant DR, Neutrino NxT VR, Neutrino NxT DR, Gallant VR, Gallant DR, Entrant VR, Entrant DR, Ellipse VR, Ellips (P910023/S478) | ABBOTT MEDICAL | 2025-05-22 |
| Dimension TPSA Flex reagent cartridge (P000021/S047) | Siemens Healthcare Diagnostics | 2025-05-22 |
| Elecsys Anti-HBc II (P100032/S023) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM (P110031/S027) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys HBeAg (P130015/S022) | Roche Diagnostics Operations, Inc. | 2025-05-22 |
| Dimension FPSA Flex reagent cartridge (P020027/S042) | Siemens Healthcare Diagnostics | 2025-05-22 |
| Aveir VR (P150035/S025) | ABBOTT MEDICAL | 2025-05-22 |
| Elecsys Anti-HBc IgM (P110022/S034) | Roche Diagnostics Corp. | 2025-05-22 |
| Allure RF, Quadra Allure, Quadra Allure MP, Quadra Allure MP RF (P030035/S209) | ABBOTT MEDICAL | 2025-05-22 |
| Elecsys HBsAg II/Elecsys HBsAg Auto Confirm (P160019/S019) | Roche Diagnostics, Inc. | 2025-05-22 |