| Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Az (P980035/S821) | Medtronic, Inc. | 2025-09-05 |
| AVEIR Leadless Pacemaker (P150035/S031) | ABBOTT MEDICAL | 2025-09-05 |
| Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua (P010031/S901) | Medtronic Cardiac Rhythm Disease Management | 2025-09-05 |
| Lutonix 018 (Model 9014) (P170003/S028) | Lutonix | 2025-09-04 |
| SURGICEL® Absorbable Hemostats (N12159/S124) | ETHICON, Inc. | 2025-09-04 |
| Sphere-9 Mapping and Ablation Catheter (P240013/S010) | Medtronic, Inc. | 2025-09-04 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S065) | ETHICON, Inc. | 2025-09-04 |
| CINtec PLUS Cytology (P190024/S015) | Ventana Medical Systems, Inc. | 2025-09-04 |
| Lutonix 035 (Model 9004 and Model 9010) (P130024/S044) | Lutonix | 2025-09-04 |
| WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (P130013/S077) | Boston Scientific Corp | 2025-09-04 |
| Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit (P220020/S005) | Sirtex Medical, Inc. | 2025-09-03 |
| RelayPlus (P110038/S034) | Bolton Medical, Inc. | 2025-09-03 |
| RelayPro (P200045/S019) | Bolton Medical, Inc. | 2025-09-03 |
| EVOLYSSE® FORM and EVOLYSSE® SMOOTH (P240022/S001) | Symatese | 2025-09-03 |
| TREO® Abdominal Stent-Graft System (P190015/S025) | Bolton Medical, Inc. | 2025-09-03 |
| ACUITY X4 Straight, Models 4671 and 4672; ACUITY X4 Spiral S, Models 4674 and 4675; ACUITY X4 Spiral L, Models 4677 and (P010012/S591) | Boston Scientific Corp | 2025-09-03 |
| Vivistim® System (P210007/S007) | Mobia Medical, Inc. | 2025-09-03 |
| WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System (P240028/S002) | EBR Systems, Inc. | 2025-09-03 |
| HeartSines samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories (P160008/S029) | Heartsine Technologies, Ltd. | 2025-09-02 |
| TECNIS 3-Piece Multifocal, Model ZMA00 (P080010/S029) | Johnson & Johnson Surgical Vision, Inc. | 2025-09-02 |
| Cochlear Nucleus® System (P970051/S237) | Cochlear Americas | 2025-09-02 |
| LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) (P160055/S045) | Rxsight, Inc. | 2025-09-02 |
| Opal HDx Ablation Connection Box (Maestro); Opal HDx Ablation Connection Box - IntellaNav StablePoint; Opal HDx Ablation (P150005/S088) | Boston Scientific Corp | 2025-09-02 |
| PRODISC L (P050010/S027) | Centinel Spine, LLC | 2025-09-02 |
| TECNIS Toric II 1-Piece IOLs, ZCU TECNIS Symfony Toric II Extended Range of Vision IOLs, ZXU TECNIS Eyhance Toric II IO (P980040/S177) | Johnson & Johnson Surgical Vision, Inc. | 2025-09-02 |
| TECNIS 3-Piece Acrylic Monofocal, Model ZA9003 (P990080/S064) | Johnson & Johnson Surgical Vision, Inc. | 2025-09-02 |
| Sphere-9 Catheter Mapping and Ablation Catheter (P240013/S015) | Medtronic, Inc. | 2025-08-29 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S448) | Medtronic, Inc. | 2025-08-29 |
| MiniMed 780G System (P160017/S124) | Medtronic Minimed, Inc. | 2025-08-29 |
| LCS Total Knee System (P830055/S348) | Depuy, Inc. | 2025-08-29 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) 00733132650927; 00733132650934; 00733132650941; 00733132650958; 00 (P200030/S022) | W. L. Gore and Associates, Inc. | 2025-08-29 |
| Proclaim Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S242) | ABBOTT MEDICAL | 2025-08-29 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S014) | ABBOTT MEDICAL | 2025-08-29 |
| GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CMDS) 00733132646890; 00733132646906; 007331326 (P040043/S144) | W. L. Gore & Associates, Inc. | 2025-08-29 |
| Proclaim Doral Root Ganglion (DRG) IPG (P150004/S089) | ABBOTT MEDICAL | 2025-08-29 |
| Infinity Deep Brain Stimulation (DBS) IPG (P140009/S123) | ABBOTT MEDICAL | 2025-08-29 |
| LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® Control QuantiFERON-TBGold Plus (P180047/S040) | DiaSorin, Inc. | 2025-08-28 |
| InterStim Therapy System; Verify Evaluation System (P080025/S328) | Medtronic Neuromodulation | 2025-08-28 |
| LIAISON® Murex Anti-HBc and LIAISON® MUREX Control anti-HBc (P180038/S027) | DiaSorin, Inc. | 2025-08-28 |
| AED Plus, AED 3, X Series, R Series, Propaq MD, AED Pro, AED 3 BLS (P160022/S042) | ZOLL Medical Corporation | 2025-08-28 |
| AED Plus, AED 3, X Series, R Series, Propaq MD, AED Pro, AED 3 BLS (P160015/S020) | ZOLL Medical Corporation | 2025-08-28 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S447) | Medtronic, Inc. | 2025-08-28 |
| LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual (P190017/S028) | DiaSorin, Inc. | 2025-08-28 |
| OrganOx metra® System (P200035/S028) | Organox Limited | 2025-08-28 |
| Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces-Quad, Spe (P840001/S604) | Medtronic Neuromodulation | 2025-08-28 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S516) | Medtronic, Inc. | 2025-08-28 |
| InterStim Therapy System; Verify Evaluation System (P970004/S433) | Medtronic Neuromodulation | 2025-08-28 |
| Avant DR CDDRA700Q, CDDRA700T; Gallant DR CDDRA500Q, CDDRA500T; Entrant DR CDDRA300Q, CDDRA300T; Neutrino NxT DR CDD (P910023/S479) | ABBOTT MEDICAL | 2025-08-27 |
| ThinPrep Processor and ThinPrep Imaging System (P950039/S041) | Hologic, Inc. | 2025-08-27 |
| Globe® Pulsed Field System (P240044) | Kardium, Inc. | 2025-08-27 |
| IsoFlex (1944) (P960030/S081) | ABBOTT MEDICAL | 2025-08-27 |
| Quartet 1456Q, 1457Q, 1458Q, 1458QL; Avant HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Gallant HF CDHFA500B, CDHFA (P030054/S436) | ABBOTT MEDICAL | 2025-08-27 |
| Evolut PRO+ System, Evolut FX System, Evolut FX+ System (P130021/S174) | Medtronic, Inc. | 2025-08-27 |
| HeartMate 3 Left Ventricular Assist System (P160054/S110) | ABBOTT MEDICAL | 2025-08-27 |
| COAPTITE Injectable Implant (P040047/S078) | Merz North America, Inc. | 2025-08-27 |
| HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) (P160008/S028) | Heartsine Technologies, Ltd. | 2025-08-27 |
| HeartMate 3 Left Ventricular Assist System (P160054/S111) | ABBOTT MEDICAL | 2025-08-26 |
| CorPASS System (P230040/S018) | Endotronix, Inc. | 2025-08-26 |
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S157) | Alcon Laboratories, Inc. | 2025-08-25 |
| Guardian Connect system (P160007/S053) | Medtronic Minimed | 2025-08-25 |
| BD ONCLARITY HPV ASSAY (P160037/S022) | Becton, Dickinson and Company | 2025-08-25 |
| MiniMed 670G System (P160017/S126) | Medtronic Minimed, Inc. | 2025-08-25 |
| XACT Carotid Stent System (P040038/S049) | Abbott Vascular, Inc. | 2025-08-25 |
| AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses\s (P040020/S115) | Alcon Research, Ltd. | 2025-08-25 |
| TAG® Thoracic Branch Endoprosthesis (P210032) (P210032/S022) | W. L. Gore & Associates, Inc. | 2025-08-25 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic Intraocular Lens, (P190018/S043) | Alcon Laboratories, LLC | 2025-08-25 |
| CraniSeal Dural Sealant (P220014/S008) | Pramand, LLC | 2025-08-25 |
| Simplera Sync Sensor, Guardian 4 Sensor (P250012/S001) | Medtronic Minimed, Inc. | 2025-08-25 |
| CardioMessenger Smart 4G (P050023/S197) | Biotronik, Inc. | 2025-08-22 |
| TRUFILL n-BCA Liquid Embolic System (P990040/S036) | Cerenovus, Inc. | 2025-08-22 |
| FINELINE® II EZ Sterox (P960004/S106) | Boston Scientific | 2025-08-22 |
| INGEVITY MRI, INGEVITY + (P150012/S153) | Boston Scientific | 2025-08-22 |
| ENDOTAK RELIANCE® S, ENDOTAK RELIANCE®, ENDOTAK RELIANCE® SG, ENDOTAK RELIANCE® G, RELIANCE 4-FRONT (P910073/S176) | Boston Scientific | 2025-08-22 |
| Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection (P240009/S004) | Contego Medical, Inc. | 2025-08-22 |
| OrganOx metra System (P200035/S026) | Organox Limited | 2025-08-22 |
| LIAISON® MUREX Anti-HBc and LIAISON® MUREX Control Anti-HBc (P180038/S026) | DiaSorin, Inc. | 2025-08-21 |
| Coseal Spray Set (P030039/S031) | Baxter Bio Science | 2025-08-21 |
| GORE TAG Thoracic Branch Endoprosthesis (TBE Device) (P210032/S019) | W. L. Gore & Associates, Inc. | 2025-08-21 |
| CentriMag Circulatory Support System (P170038/S026) | Abbott | 2025-08-21 |
| Melody Transcatheter Pumonary Valve System (P140017/S031) | Medtronic, Inc. | 2025-08-21 |
| LIAISON® MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg Qual and LIAISON® MUREX HBsAg Confirmatory (P190017/S027) | DiaSorin, Inc. | 2025-08-21 |
| LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S038) | DiaSorin, Inc. | 2025-08-21 |
| Visumax; VISUMAX 800 (P150040/S021) | Carl Zeiss Meditec, Inc. | 2025-08-21 |
| Saluda Medical Evoke SCS System (P190002/S041) | Saluda Medical Pty, Ltd. | 2025-08-21 |
| Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) (P150033/S215) | Medtronic, Inc. | 2025-08-21 |
| MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S208) | Medtronic, Inc. | 2025-08-20 |
| OrganOx metra® System (P200035/S025) | Organox Limited | 2025-08-20 |
| GORE® EXCLUDER® AAA Endoprosthesis (P020004/S202) | W. L. Gore & Associates, Inc. | 2025-08-20 |
| up&up Monthly Performance + (P080011/S184) | CooperVision, Inc. | 2025-08-20 |
| HiResolution Bionic Ear System (P960058/S171) | Advanced Bionics | 2025-08-20 |
| Surpass Streamline Flow Diverter (P170024/S024) | Stryker Neurovascular | 2025-08-20 |
| iWear oxygen presbyopia (P080011/S186) | CooperVision, Inc. | 2025-08-20 |
| iCast Covered Stent System (P120003/S010) | Atrium Medical Corp. | 2025-08-20 |
| MiniMed 770G System (P160017/S122) | Medtronic Minimed, Inc. | 2025-08-20 |
| TriClip G5 Delivery System (P230007/S015) | ABBOTT MEDICAL | 2025-08-20 |
| CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P (P100016/S022) | Carl Zeiss Meditec Production, LLC | 2025-08-20 |
| MitraClip G5 Delivery System (P100009/S078) | ABBOTT MEDICAL | 2025-08-20 |
| Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati (P230022/S001) | Element Science, Inc. | 2025-08-20 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System (P170030/S055) | Biotronik AG | 2025-08-19 |
| THINLINE ENDOCARDIAL PACING LEADS (P960004/S108) | Boston Scientific | 2025-08-19 |