| Alinity i Anti-HBc IgM Reagent Kit (2x100 Tests) (P060035/S040) | Abbott Laboratories | 2023-11-03 |
| CapSure Sense Lead (P830061/S219) | Medtronic Cardiac Rhythm Disease Management | 2023-11-03 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S526) | Medtronic, Inc. | 2023-11-03 |
| CapSure VDD-2 Lead (P890003/S464) | Medtronic, Inc. | 2023-11-03 |
| 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/S868) | Medtronic Cardiac Rhythm Disease Management | 2023-11-03 |
| Transvene CS/SVC Lead (P980050/S142) | Medtronic, Inc. | 2023-11-03 |
| Attain StarFix Lead (P060039/S115) | Medtronic, Inc. | 2023-11-03 |
| CapSure Epicardial Pacing Lead (P950024/S109) | Medtronic, Inc. | 2023-11-03 |
| Harmony TPV System (P200046/S023) | Medtronic, Inc. | 2023-11-03 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S179) | Medtronic, Inc. | 2023-11-03 |
| Adapta, Versa, Sensia IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Azure S DR MRI (P980035/S761) | Medtronic, Inc. | 2023-11-03 |
| Onyx Liquid Embolic System (P030004/S030) | Ev3 Neurovascular | 2023-11-03 |
| Epicardial Patch Lead (P900061/S172) | Medtronic Cardiac Rhythm Disease Management | 2023-11-03 |
| CapSureFix Lead, CapSureFix Novus Lead (P930039/S255) | Medtronic, Inc. | 2023-11-03 |
| Alinity i HBsAg Qualitative II Reagent Kit (2x100 Tests), Alinity i HBsAg Qualitative II Reagent Kit (2x600 Tests), Alin (P110029/S046) | Abbott Laboratories | 2023-11-03 |
| Sprint Quattro Lead, Subcutaneous Lead (P920015/S282) | Medtronic, Inc. | 2023-11-03 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, (P010031/S834) | Medtronic Cardiac Rhythm Disease Management | 2023-11-03 |
| Myocardial Pacing Lead (P120017/S034) | Medtronic, Inc. | 2023-11-03 |
| SelectSecure Lead (P030036/S145) | Medtronic Cardiac Rhythm Disease Management | 2023-11-03 |
| EV ICD Aurora (P220012/S001) | Medtronic, Inc. | 2023-11-02 |
| Gore Excluder Conformable AAA Endoprosthesis(EXCC) (P200030/S015) | W. L. Gore and Associates, Inc. | 2023-11-02 |
| LIFEPAK® 15 Defibrillator Lithium- ion Rechargeable Battery Accessory (P160026/S045) | Physio-Control, Inc. | 2023-11-02 |
| PALMAZ MULLINS XD Pulmonary Stent (P220004/S001) | Cordis US Corp | 2023-11-02 |
| 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, Cobalt (P010031/S835) | Medtronic Cardiac Rhythm Disease Management | 2023-11-02 |
| Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR (P070008/S155) | Biotronik, Inc. | 2023-11-02 |
| FoundationOne CDx (F1CDx) (P170019/S049) | Foundation Medicine, Inc. | 2023-11-02 |
| Oncomine Dx Target Test (P160045/S044) | Life Technologies Corporation | 2023-11-02 |
| Pamira S 60, Pamira S 65, Pamira S 75, Pamira SD 60/16, Pamira SD 65/16, Pamira SD 65/18, Pamira SD 75/18, Pamira S DX 6 (P980023/S123) | Biotronik, Inc. | 2023-11-02 |
| Seprafilm Adhesion Barrier (P950034/S056) | Baxter Healthcare Corporation | 2023-11-02 |
| Viva Quad XT CRTD, Viva XT CRT-D, Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI DF-1 I (P980016/S869) | Medtronic Cardiac Rhythm Disease Management | 2023-11-02 |
| Harmony Transcatheter Pulmonary Valve (P200046/S025) | Medtronic, Inc. | 2023-11-01 |
| Alinity m HR HPV (P230003) | Abbott Molecular, Inc. | 2023-11-01 |
| Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medtronic Evolut PRO+ Transcatheter Aortic Valve, Medtroni (P130021/S149) | Medtronic, Inc. | 2023-11-01 |
| SURGICEL® Absorbable Hemostats (N12159/S107) | ETHICON, Inc. | 2023-11-01 |
| Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medtronic Evolut PRO+ Transcatheter Aortic Valve, Medtroni (P130021/S148) | Medtronic, Inc. | 2023-11-01 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System RX and OTW (P160043/S074) | Medtronic Vascular | 2023-11-01 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S056) | ETHICON, Inc. | 2023-11-01 |
| Harmony Transcatheter Pulmonary Valve (P200046/S024) | Medtronic, Inc. | 2023-11-01 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S088) | Syncardia Systems, LLC | 2023-11-01 |
| Elecsys Anti-HBe (P190005/S003) | Roche Diagnostics | 2023-10-31 |
| Elecsys Anti-HBs (P010054/S044) | Roche Diagnostics Corp. | 2023-10-31 |
| Elecsys HBsAg II, Elecsys HBsAg II Auto Confirm (P160019/S015) | Roche Diagnostics, Inc. | 2023-10-31 |
| WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S059) | Boston Scientific Corp | 2023-10-31 |
| Elecsys HBeAg (P130015/S018) | Roche Diagnostics Operations, Inc. | 2023-10-31 |
| Cordis® EXOSEAL® Vascular Closure Device (P100013/S028) | Cordis US Corporation | 2023-10-31 |
| Avant, Neutrino NxT, Gallant, Entrant, Ellipse, Fortify Assura (P910023/S458) | ABBOTT MEDICAL | 2023-10-31 |
| Elecsys Anti-HBc II (P100031/S029) | Roche Diagnostics Corp. | 2023-10-31 |
| Avant, Neutrino NxT, Gallant, Entrant, Unify, Unify Assura, Quadra Assura (P030054/S413) | ABBOTT MEDICAL | 2023-10-31 |
| INSPIRIS RESILIA Aortic Valve (P150048/S075) | Edwards Lifesciences, LLC | 2023-10-31 |
| Elecsys Anti-HBs II (P190034/S004) | Roche Diagnostics | 2023-10-31 |
| Elecsys Anti-HBc IgM (P110022/S029) | Roche Diagnostics Corp. | 2023-10-31 |
| IC-8 Apthera intraocular lens (IOL) (P210005/S006) | Acu Focus, Inc. | 2023-10-30 |
| Edwards Commander Delivery System (P140031/S165) | Edwards Lifesciences, LLC | 2023-10-30 |
| Edwards Commander Delivery System (P200015/S047) | Edwards Lifesciences, LLC | 2023-10-30 |
| MiniMed 670G system, MiniMed 770G system and MiniMed 780G system (P160017/S113) | Medtronic Minimed, Inc. | 2023-10-30 |
| Philips Laser System (P910001/S121) | Spectranetics Corp. | 2023-10-30 |
| FLEXATOME CUTTING BALLOON (P950020/S141) | Boston Scientific Corp | 2023-10-30 |
| MiniMed 630G system (P150001/S107) | Medtronic Minimed | 2023-10-30 |
| GORE® CARDIOFORM Septal Occluder (P050006/S108) | W. L. Gore & Associates, Inc. | 2023-10-30 |
| TOPS System (P220002/S003) | Premia Spine, Ltd. | 2023-10-27 |
| Spinal Cord Stimulation (SCS) Legacy Charger Systems and Accessories (P010032/S207) | ABBOTT MEDICAL | 2023-10-27 |
| Hancock Modified Orifice Valved Conduit (P790007/S065) | Medtronic Heart Valves | 2023-10-27 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S061) | ABBOTT MEDICAL | 2023-10-27 |
| Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico (P070008/S153) | Biotronik, Inc. | 2023-10-27 |
| OrganOx metra System (P200035/S012) | Organox Limited | 2023-10-27 |
| Freestyle Bioprosthesis (P970031/S071) | Medtronic, Inc. | 2023-10-27 |
| NovaSure Impedance Controlled Endometrial Ablation System (P010013/S091) | Hologic, Inc. | 2023-10-27 |
| LCS(R) TOTAL KNEE SYSTEM (P830055/S315) | Depuy, Inc. | 2023-10-27 |
| Hancock Valved Conduit (P870078/S050) | Medtronic, Inc. | 2023-10-27 |
| XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S (P110019/S128) | Abbott Vascular | 2023-10-27 |
| Avalus Bioprosthesis (P170006/S028) | Medtronic, Inc. | 2023-10-27 |
| Hancock II Bioprosthesis (P980043/S077) | Medtronic, Inc. | 2023-10-27 |
| MitraClip G4 Clip Delivery System (P100009/S060) | ABBOTT MEDICAL | 2023-10-27 |
| Gambro Prismaflex TPE 2000 Set (P830063/S026) | Vantive US Healthcare, LLC | 2023-10-27 |
| MyChoice® CDx (P190014/S008) | Myriad Genetic Laboratories, Inc. | 2023-10-27 |
| CardioMEMSTM HF System (P100045/S070) | ABBOTT MEDICAL | 2023-10-27 |
| RHA®3 dermal filler (P170002/S030) | Teoxane S.A. | 2023-10-27 |
| Deep Brain Stimulation (DBS) Legacy Charger Systems and Accessories (P140009/S090) | ABBOTT MEDICAL | 2023-10-27 |
| Mosaic Bioprosthesis (P990064/S086) | Medtronic, Inc. | 2023-10-27 |
| LAVA® Liquid Embolic System (LAVA LES) (P220020/S001) | Sirtex Medical, Inc. | 2023-10-26 |
| Visi-Pro Balloon-expandable Peripheral Stent System (P030045/S008) | Medtronic Vascular, Inc. | 2023-10-26 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S088) | St Jude Medical | 2023-10-26 |
| FlexAbility Ablation Catheter, FlexAbility Ablation Catheter, Sensor Enabled (P110016/S086) | ABBOTT MEDICAL | 2023-10-26 |
| Prestige LP® Cervical Disc (P090029/S019) | Medtronic Sofamor Danek USA, Inc. | 2023-10-26 |
| Biomet EBI Bone Healing System (P790002/S039) | Ahp Eos Buyer, Inc. | 2023-10-26 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S034) | Biotronik AG | 2023-10-26 |
| Livewire TC XLS Ablation Catheter, Livewire TC XLS Bi-Directional Ablation Catheter, Livewire TC Catheter Extension (P960016/S091) | St Jude Medical | 2023-10-26 |
| Eterna SCS IPG (P010032/S205) | ABBOTT MEDICAL | 2023-10-26 |
| Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System & Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator S (P850022/S033) | Ahp Eos Buyer, Inc. | 2023-10-26 |
| Integra Dermal Regeneration Template - Terminally Sterilized, Integra Meshed Dermal Regeneration Template - Terminally S (P900033/S110) | Integra Lifesciences Corp. | 2023-10-26 |
| TactiFlex Ablation CatTactiFlex Ablation Catheter, Sensor Enabledheter, Sensor Enabled, TactiSys Quartz Equipment, (P220013/S008) | ABBOTT MEDICAL | 2023-10-26 |
| Tunneling Tool (P920015/S277) | Medtronic, Inc. | 2023-10-26 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S063) | Boston Scientific Corp | 2023-10-25 |
| ASSURE Wearable Cardioverter Defibrillator System (ASSURE system) (P200037/S010) | Kestra Medical Technologies, Inc. | 2023-10-25 |
| PMMA Single-Piece Anterior Chamber Intraocular Lens (P880087/S032) | Alcon Laboratories | 2023-10-25 |
| iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231, IPure Preloaded IOL System / Model B1PC (Clear (P080004/S047) | Hoya Surgical Optics, Inc. | 2023-10-25 |
| Pipeline Vantage Embolization Device with Shield Technology (P100018/S042) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2023-10-25 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S063) | ABBOTT MEDICAL | 2023-10-25 |
| Nucleus® Hybrid L24 Cochlear Implant System (P130016/S054) | Cochlear Americas | 2023-10-25 |
| Nucleus® 24 Auditory Brainstem Implant System (P000015/S051) | Cochlear Americas | 2023-10-25 |