| InterStim® Therapy System, Verify® Evaluation System (P080025/S310) | Medtronic Neuromodulation | 2024-12-05 |
| NEO 2401.U/1 (P950037/S262) | Biotronik, Inc. | 2024-12-05 |
| NEO 2401.U/1 (P070008/S159) | Biotronik, Inc. | 2024-12-05 |
| Defibtech Lifeline, Defibtech Lifeline AUTO (P160032/S012) | Defibtech, LLC | 2024-12-05 |
| Master Intellis Spinal Cord Stimulation System, Vanta Spinal Cord Stimulation System, Inceptiv Spinal Cord Stimulati (P840001/S584) | Medtronic Neuromodulation | 2024-12-05 |
| NEO 2401.U/1 (P000009/S114) | Biotronik, Inc. | 2024-12-05 |
| NEO 2401.U/1 (P050023/S187) | Biotronik, Inc. | 2024-12-05 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S496) | Medtronic, Inc. | 2024-12-05 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis (P200030/S016) | W. L. Gore and Associates, Inc. | 2024-12-04 |
| Mentor® MemoryGel® Silicone Gel-Filled Breast Implants (P030053/S071) | Mentor Corp. | 2024-12-04 |
| AeroPace® System (P240012) | Lungpacer Medical USA, Inc. | 2024-12-04 |
| Zephyr Endobronchial Valve System (P180002/S029) | Pulmonx Corporation | 2024-12-04 |
| Mentor® MemoryShape® Breast Implants (P060028/S050) | Mentor Worldwide, LLC | 2024-12-04 |
| Mentor® Saline-Filled and SPECTRUM® Breast Implants (P990075/S059) | Mentor Worldwide, LLC | 2024-12-04 |
| MEL90 (P060004/S006) | Carl Zeiss Meditec, Inc. | 2024-12-04 |
| RELIANCE 4-FRONT (P910073/S179) | Boston Scientific | 2024-12-03 |
| Infinity Deep Brain Stimulation (DBS) IPG (P140009/S107) | ABBOTT MEDICAL | 2024-12-03 |
| Senza Spiral Cord Stimulation (SCS) System (P130022/S062) | Nevro Corporation | 2024-12-03 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S064) | Nevro Corporation | 2024-12-03 |
| HeartMate II Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit (P060040/S109) | ABBOTT MEDICAL | 2024-12-03 |
| Filshie Clip (Mark VI) System (P920046/S015) | Femcare , Ltd. | 2024-12-03 |
| IN.PACT AV DCB (P190008/S033) | Medtronic Vascular, Inc. | 2024-12-03 |
| Proclaim Doral Root Ganglion (DRG) IPG (P150004/S077) | ABBOTT MEDICAL | 2024-12-03 |
| HeartMate 3 Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit (P160054/S087) | ABBOTT MEDICAL | 2024-12-03 |
| Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S181) | Edwards Lifesciences, LLC | 2024-12-03 |
| IN.PACT Admiral DCB (P140010/S084) | Medtronic, Inc. | 2024-12-03 |
| INSPIRIS RESILIA Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC), MITRIS RESILIA Mitral Valve (P150048/S086) | Edwards Lifesciences, LLC | 2024-12-03 |
| Senza Spiral Cord Stimulation (SCS) System (P130022/S063) | Nevro Corporation | 2024-12-03 |
| Saluda Medical Evoke SCS System (P190002/S017) | Saluda Medical Pty, Ltd. | 2024-12-03 |
| Proclaim Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S226) | ABBOTT MEDICAL | 2024-12-03 |
| Impella CP with SmartAssist, Impella 5.5 with SmartAssist (P140003/S111) | Abiomed, Inc. | 2024-12-03 |
| LDR Spine Mobi-C Cervical Disc Prosthesis (P110009/S036) | Highridge Medical, LLC | 2024-12-02 |
| UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery (P220030/S002) | Alcon Research, LLC | 2024-12-02 |
| UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy (P230012/S002) | Alcon Research, LLC | 2024-12-02 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR (P980035/S801) | Medtronic, Inc. | 2024-12-02 |
| CapSureFix Novus Lead (P930039/S267) | Medtronic, Inc. | 2024-12-02 |
| Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Crome MRI ICD (P980016/S909) | Medtronic Cardiac Rhythm Disease Management | 2024-12-02 |
| LDR Spine Mobi-C Cervical Disc Prosthesis (P110002/S036) | Highridge Medical, LLC | 2024-12-02 |
| Light Adjustable Lens and Light Delivery Device (P160055/S037) | Rxsight, Inc. | 2024-12-02 |
| CapSure Sense Lead (P830061/S227) | Medtronic Cardiac Rhythm Disease Management | 2024-12-02 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S875) | Medtronic Cardiac Rhythm Disease Management | 2024-12-02 |
| TactiCath Ablation Catheter, Sensor Enabled (TactiCath SE) (P130026/S092) | St Jude Medical | 2024-11-27 |
| Axonics Sacral Neuromodulation System (P190006/S093) | Boston Scientific Corporation | 2024-11-27 |
| Aurora EV ICD (P220012/S035) | Medtronic, Inc. | 2024-11-27 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S907) | Medtronic Cardiac Rhythm Disease Management | 2024-11-27 |
| TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) (P220013/S015) | ABBOTT MEDICAL | 2024-11-27 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria Quad MRI CRT-D, Cobalt (P010031/S873) | Medtronic Cardiac Rhythm Disease Management | 2024-11-27 |
| Axonics Sacral Neuromodulation System (P180046/S093) | Boston Scientific Corporation | 2024-11-27 |
| ANGIO-SEAL VIP Vascular Closure Device (P930038/S105) | Terumo Medical Corporation | 2024-11-26 |
| Lumicell Direct Visualization System (P230014/S002) | Lumicell, Inc. | 2024-11-26 |
| MENTOR MemoryGel Breast Implants (P030053/S075) | Mentor Corp. | 2024-11-26 |
| EPIC SELF-EXPANDING NITINOL STENT SYSTEM (P110035/S073) | Boston Scientific Corp | 2024-11-26 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S063) | Boston Scientific Corp | 2024-11-26 |
| Innova Vascular Self Expanding Stent with Delivery System (P140028/S081) | Boston Scientific Corporation | 2024-11-26 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S055) | Medinol, Ltd. | 2024-11-26 |
| MENTOR Saline-Filled and SPECTRUM Breast Implants (P990075/S061) | Mentor Worldwide, LLC | 2024-11-26 |
| MENTOR MemoryShape Breast Implants (P060028/S053) | Mentor Worldwide, LLC | 2024-11-26 |
| TriClip G4 Clip Delivery System (P230007/S008) | ABBOTT MEDICAL | 2024-11-25 |
| InterStim Therapy System, Verify Evaluation System (P970004/S412) | Medtronic Neuromodulation | 2024-11-25 |
| L100 ESSENTIO SR, L101 ESSENTIO DR, L121 ESSENTIO EL DR, L200 PROPONENT SR, L201 PROPONENT DR, L221 PROPONENT EL DR, L30 (N970003/S297) | Boston Scientific Corp | 2024-11-25 |
| A209 SICD Gen 2, A219 SICD MRI (P110042/S201) | Boston Scientific Corporation | 2024-11-25 |
| Nitron CryoConsole, Nitron Foot Switch (P020045/S110) | Medtronic Cryocath, LP | 2024-11-25 |
| G124 MOMENTUM CRT-D, G125 MOMENTUM CRT-D, G126 MOMENTUM CRT-D, G128 MOMENTUM, G138 MOMENTUM X4 CRT-D, G140 INOGEN CRT-D, (P010012/S588) | Boston Scientific Corp | 2024-11-25 |
| D010 INOGEN MINI ICD VR, D011 INOGEN MINI ICD VR, D012 INOGEN MINI ICD DR, D013 INOGEN MINI ICD DR, D020 DYNAGEN MINI IC (P960040/S503) | Boston Scientific | 2024-11-25 |
| Axonics Sacral Neuromodulation System (P190006/S092) | Boston Scientific Corporation | 2024-11-25 |
| Total Artificial Heart (P030011/S092) | Syncardia Systems, LLC | 2024-11-25 |
| MITRIS RESILIA Mitral Valve (P150048/S085) | Edwards Lifesciences, LLC | 2024-11-25 |
| Propel® Contour Sinus Implant (P100044/S055) | Intersect Ent. | 2024-11-25 |
| RelayPro Thoracic Stent-Graft System (P200045/S005) | Bolton Medical, Inc. | 2024-11-25 |
| Axonics Sacral Neuromodulation System (P180046/S092) | Boston Scientific Corporation | 2024-11-25 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-expanding Peripheral Stent with Entrust Delivery Syste (P110023/S053) | Medtronic Vascular, Inc. | 2024-11-25 |
| U125 VALITUDE CRT-P, U128 VALITUDE X4 CRT-P, U225 VISIONIST CRT-P, U226 VISIONIST CRT-P, U228 VISIONIST X4 CRT-P (P030005/S243) | Guidant Corp. | 2024-11-25 |
| L110 ESSENTIO MRI SR, L111 ESSENTIO MRI DR, L131 ESSENTIO MRI EL DR, L210 PROPONENT, L211 PROPONENT, L231 PROPONENT, L31 (P150012/S163) | Boston Scientific | 2024-11-25 |
| InterStim Therapy System, Verify Evaluation System (P080025/S307) | Medtronic Neuromodulation | 2024-11-25 |
| MitraClip G4 Clip Delivery System, MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System (P100009/S069) | ABBOTT MEDICAL | 2024-11-25 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S221) | Medtronic | 2024-11-25 |
| LifeVest® Wearable Defibrillator (P010030/S188) | Zoll Manufacturing Corporation | 2024-11-24 |
| Aveir Leadless Pacemaker- Right Atrial, Aveir Leadless Pacemaker- Right Ventricular, (P150035/S020) | ABBOTT MEDICAL | 2024-11-22 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S035) | Medtronic Vascular, Inc. | 2024-11-22 |
| Cerene Cryotherapy Device (P180032/S019) | Channel Medsystems, Inc. | 2024-11-22 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S874) | Medtronic Cardiac Rhythm Disease Management | 2024-11-22 |
| RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P160043/S085) | Medtronic Vascular | 2024-11-22 |
| SCS EPG 2-Port Header (Model 3042) (P010032/S217) | ABBOTT MEDICAL | 2024-11-22 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S145) | Boston Scientific Corp | 2024-11-22 |
| Aurora EV ICD (P220012/S036) | Medtronic, Inc. | 2024-11-22 |
| OUS Vitatron Application Software (P890003/S470) | Medtronic, Inc. | 2024-11-22 |
| MemoryGel® Ultra High Profile - Extended Range (UH-R) Breast Implants (P030053/S069) | Mentor Corp. | 2024-11-22 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, (P980016/S908) | Medtronic Cardiac Rhythm Disease Management | 2024-11-22 |
| Oxford® Partial Knee System (P010014/S107) | Biomet Manufacturing Corp | 2024-11-22 |
| IsoMed Infusion System (P990034/S045) | Medtronic, Inc. | 2024-11-22 |
| TactiCath Ablation Catheter, Sensor Enabled (P130026/S091) | St Jude Medical | 2024-11-22 |
| Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110031/S025) | Roche Diagnostics Corp. | 2024-11-22 |
| Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas (P230005/S001) | Motiva USA, LLC | 2024-11-22 |
| Affera Sphere-9 Mapping and Ablation Catheter (P240013/S002) | Medtronic, Inc. | 2024-11-22 |
| Avant, Entrant, Fortify, Fortify Assura, Gallant, Neutrino NxT (P910023/S473) | ABBOTT MEDICAL | 2024-11-22 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S014) | ABBOTT MEDICAL | 2024-11-22 |
| Sphere-9 Mapping and Ablation Catheter, Catheter Extension Cable, Tubing Set (P240013/S001) | Medtronic, Inc. | 2024-11-22 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S434) | Medtronic, Inc. | 2024-11-22 |
| Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110022/S031) | Roche Diagnostics Corp. | 2024-11-22 |
| Saluda Medical Evoke® SCS System (P190002/S032) | Saluda Medical Pty, Ltd. | 2024-11-22 |