| AvertD and AvertD Buccal Sample Collection Kit (P230032/S001) | AutoGenomics, Inc. | 2024-02-16 |
| 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/S879) | Medtronic Cardiac Rhythm Disease Management | 2024-02-16 |
| SmartAblate Irrigation Tubing Set (SAT001) (P990071/S058) | Biosense Webster, Inc. | 2024-02-16 |
| IntellaNav XP and IntellaNav MiFi XP Ablation Catheters (P020025/S143) | Boston Scientific | 2024-02-16 |
| 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/S845) | Medtronic Cardiac Rhythm Disease Management | 2024-02-16 |
| BioMimics 3D Vascular Stent System (P180003/S007) | Veryan Medical, Ltd. | 2024-02-16 |
| Aurora EV ICD (P220012/S012) | Medtronic, Inc. | 2024-02-16 |
| WaveLight EX500 Laser (P030008/S038) | Alcon Laboratories, Inc. | 2024-02-15 |
| Prospera SCS System Next Generation Active Anchor, TrueLock (P210037/S002) | Biotronik Nro, Inc. | 2024-02-15 |
| WaveLight EX500 Laser (P020050/S042) | Alcon Laboratories, Inc. | 2024-02-15 |
| XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S (P110019/S132) | Abbott Vascular | 2024-02-15 |
| Symplicity Spyral Multi-Electrode Renal Denervation Catheter, Symplicity G3 Renal Devervation RF Generator (P220026/S001) | Medtronic, Inc. | 2024-02-15 |
| GEM21S® Growth Factor Enhanced Matrix (P040013/S030) | Lynch Biologics, LLC | 2024-02-14 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S773) | Medtronic, Inc. | 2024-02-14 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S066) | Boston Scientific Corp | 2024-02-14 |
| Consulta CRT-P, Syncra CRT-P (P010015/S533) | Medtronic, Inc. | 2024-02-14 |
| AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S034) | Spectranetics Corp. | 2024-02-14 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Edwards SAPIEN 3 Ultra THV, and Edwards SAPIAN 3 Ultra RESILIA THV (P140031/S170) | Edwards Lifesciences, LLC | 2024-02-14 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S041) | Berlin Heart, Inc. | 2024-02-14 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Edwards SAPIEN 3 Ultra THV, and Edwards SAPIAN 3 Ultra RESILIA THV (P200015/S052) | Edwards Lifesciences, LLC | 2024-02-14 |
| LifeVest® Wearable Defibrillator (P010030/S170) | Zoll Manufacturing Corporation | 2024-02-14 |
| MitraClip G4 System (P100009/S063) | ABBOTT MEDICAL | 2024-02-14 |
| INSPIRIS RESILIA Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC) (P150048/S078) | Edwards Lifesciences, LLC | 2024-02-13 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S043) | Medtronic Vascular, Inc. | 2024-02-13 |
| Abre Venous Self-expanding Stent System (P200026/S007) | Medtronic Vascular, Inc. | 2024-02-13 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, (P130021/S156) | Medtronic, Inc. | 2024-02-13 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S531) | Medtronic, Inc. | 2024-02-13 |
| Harmony Transcatheter Pulmonary Valve (P200046/S028) | Medtronic, Inc. | 2024-02-13 |
| Avalus Bioprosthesis, Avalus Ultra Bioprosthesis (P170006/S032) | Medtronic, Inc. | 2024-02-13 |
| NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088) | Zimmer, Inc. | 2024-02-13 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S771) | Medtronic, Inc. | 2024-02-13 |
| Atellica IM complexed PSA (cPSA) (P990055/S025) | Siemens Healthcare Diagnostics | 2024-02-13 |
| Edwards INTUITY Elite Valve System (P150036/S073) | Edwards Lifesciences, LLC | 2024-02-13 |
| Carpentier-Edwards® PERIMOUNT Family of Pericardial Bioprostheses (P860057/S216) | Edwards Lifesciences, LLC | 2024-02-13 |
| TRUFILL n-BCA Liquid Embolic System (LES) Procedural Set (P990040/S032) | Cerenovus, Inc. | 2024-02-13 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S183) | Medtronic, Inc. | 2024-02-13 |
| Melody Transcatheter Pulmonary Valve (P140017/S028) | Medtronic, Inc. | 2024-02-13 |
| Rayner c .. flex 570C, C-flex Aspheric 97 C, 600C Aspheric lntraocular lenses, RayOne Aspheric RAO600C, RayOne Spheric R (P060011/S036) | Rayner Intraocular Lenses , Ltd. | 2024-02-12 |
| Resolute Onyx RX Zotarolimus-Eluting Coronary Stent System, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System, (P160043/S077) | Medtronic Vascular | 2024-02-12 |
| LifeVest® Wearable Defibrillator (P010030/S175) | Zoll Manufacturing Corporation | 2024-02-10 |
| OPTIMIZER Smart Mini IPG (P180036/S025) | Impulse Dynamics (Usa), Inc. | 2024-02-09 |
| Xstim Spine Fusion Stimulator (P230025) | Xstim, Inc. | 2024-02-09 |
| QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus Test (P010033/S050) | Qiagen | 2024-02-09 |
| Light Adjustable Lens and Light Delivery Device (P160055/S033) | Rxsight, Inc. | 2024-02-08 |
| Axonics Sacral Neuromodulation System (P190006/S076) | Boston Scientific Corporation | 2024-02-08 |
| Elecsys Anti-HBc IgM (P110022/S030) | Roche Diagnostics Corp. | 2024-02-08 |
| Barricaid® Annular Closure Device (P160050/S008) | Intrinsic Therapeutics | 2024-02-08 |
| Elecsys HBeAg (P130015/S019) | Roche Diagnostics Operations, Inc. | 2024-02-08 |
| Elecsys Anti-HBe (P190005/S004) | Roche Diagnostics | 2024-02-08 |
| Elecsys Anti-HBs (P010054/S045) | Roche Diagnostics Corp. | 2024-02-08 |
| Axonics Sacral Neuromodulation System (P180046/S076) | Boston Scientific Corporation | 2024-02-08 |
| Zilver Vena Venous Self-Expanding Stent (P200023/S007) | Cook Ireland, Ltd. | 2024-02-08 |
| Atellica IM Alpha Fetoprotein (AFP) (P930036/S021) | Siemens Healthcare Diagnostics, Inc. | 2024-02-08 |
| Elecsys Anti-HBc II (P100031/S030) | Roche Diagnostics Corp. | 2024-02-08 |
| Elecsys free PSA (P000027/S039) | Roche Diagnostics Corp. | 2024-02-08 |
| Elecsys Anti-HBs II (P190034/S006) | Roche Diagnostics | 2024-02-08 |
| FoundationOne Liquid CDx (F1LCDx) (P190032/S018) | Foundation Medicine, Inc. | 2024-02-08 |
| Elecsys HBsAg II (P160019/S016) | Roche Diagnostics, Inc. | 2024-02-08 |
| Elecsys total PSA (P990056/S041) | Roche Diagnostics Corp. | 2024-02-08 |
| TheraSphereTM Y-90 Glass Microspheres System (P200029/S008) | Boston Scientific Corporation | 2024-02-07 |
| Sculptra® (P030050/S045) | Q-Med AB | 2024-02-07 |
| Gore Viatorr TIPS (P040027/S095) | W. L. Gore & Associates, Inc. | 2024-02-07 |
| XACT Carotid Stent System (P040038/S043) | Abbott Vascular, Inc. | 2024-02-07 |
| TheraSphere (P200029/S006) | Boston Scientific Corporation | 2024-02-06 |
| Symplicity Spyral Renal Denervation System (P220026/S002) | Medtronic, Inc. | 2024-02-06 |
| GORE® VIATORR® TIPS Endoprosthesis, GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (P040027/S096) | W. L. Gore & Associates, Inc. | 2024-02-06 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S134) | Vistakon, Division of Johnson & Johnson Vision Car | 2024-02-05 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S067) | Coloplast Corp. | 2024-02-05 |
| Alinity m HR HPV (P230003/S001) | Abbott Molecular, Inc. | 2024-02-05 |
| Alinity m CMV (P210022/S009) | Abbott Molecular, Inc. | 2024-02-05 |
| WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli (P130013/S064) | Boston Scientific Corp | 2024-02-05 |
| Spectra WaveWriter SCS System, WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS System (P030017/S363) | Boston Scientific Corp | 2024-02-05 |
| ReCor Paradise® Ultrasound Renal Denervation System (P220023/S002) | Recor Medical, Inc. | 2024-02-05 |
| Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S012) | MicroVention, Inc. | 2024-02-05 |
| Alinity m HBV (P200013/S018) | Abbott Molecular, Inc. | 2024-02-05 |
| HeartMate 3 Left Ventricular Assist System (P160054/S064) | ABBOTT MEDICAL | 2024-02-02 |
| Spinal Cord Stimulation (SCS) Leads (P010032/S209) | ABBOTT MEDICAL | 2024-02-02 |
| EUFLEXXA® (1% sodium hyaluronate) (P010029/S036) | Ferring Pharmaceuticals, Inc. | 2024-02-02 |
| Optune (P100034/S032) | Novocure, GmbH | 2024-02-02 |
| Vega Endocardial Pacing Leads (P130010/S001) | MicroPort CRM USA, Inc. | 2024-02-02 |
| Infinity Deep Brain Stimulation (DBS) Leads (P140009/S091) | ABBOTT MEDICAL | 2024-02-02 |
| Edwards EVOQUE Tricuspid Valve Replacement System (P230013) | Edwards Lifesciences, LLC | 2024-02-01 |
| Nitron CryoConsole and Nitron Remote (P020045/S105) | Medtronic Cryocath, LP | 2024-02-01 |
| Sientra Silicone Gel Breast Implants (P070004/S042) | Tiger Aesthetics Medical, LLC | 2024-02-01 |
| NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S087) | Zimmer, Inc. | 2024-02-01 |
| LifeVest® Wearable Defibrillator (P010030/S174) | Zoll Manufacturing Corporation | 2024-02-01 |
| Tula® System (P190016/S007) | Tusker Medical, Inc. | 2024-02-01 |
| HeartMate 3 Left Ventricular Assist System (P160054/S070) | ABBOTT MEDICAL | 2024-01-31 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S003) | Roche Diagnostics | 2024-01-31 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System (P160043/S076) | Medtronic Vascular | 2024-01-31 |
| Endurant II Stent Graft System (P100021/S119) | Medtronic Vascular | 2024-01-31 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S098) | ABBOTT MEDICAL | 2024-01-31 |
| Valiant Thoracic Stent Graft with Captivia Delivery System (P100040/S061) | Medtronic Vascular | 2024-01-31 |
| In.Pact Admiral Paclitaxel-Coated PTA Balloon Catheter, In.Pact 018 Paclitaxel-Coated PTA Balloon Catheter (P140010/S078) | Medtronic, Inc. | 2024-01-31 |
| Sculptra® (P030050/S047) | Q-Med AB | 2024-01-31 |
| Elecsys Anti-HBs, PreciControl Anti-HBs (P010054/S043) | Roche Diagnostics Corp. | 2024-01-31 |
| CardioMEMS HF System (P100045/S072) | ABBOTT MEDICAL | 2024-01-31 |
| IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S077) | Medtronic, Inc. | 2024-01-31 |
| CoreValve EnVeo Pro Delivery Catheter System (P130021/S152) | Medtronic, Inc. | 2024-01-31 |
| Avalus Ultra Bioprosthesis (P170006/S025) | Medtronic, Inc. | 2024-01-31 |