| Venaseal Closure System (P140018/S040) | Medtronic Vascular, Inc. | 2023-10-12 |
| ARCHITECT Free PSA, Alinity i Free PSA (P980007/S049) | Abbott Laboratories | 2023-10-11 |
| Axonics Sacral Neuromodulation System (P180046/S074) | Boston Scientific Corporation | 2023-10-11 |
| ANGIO-SEAL VIP Vascular Closure Device (P930038/S101) | Terumo Medical Corporation | 2023-10-11 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S038) | Abbott Laboratories | 2023-10-11 |
| Axonics Sacral Neuromodulation System (P190006/S074) | Boston Scientific Corporation | 2023-10-11 |
| ARCHITECT HBsAg Qualitative / HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II / HBsAg Qualitative II Conf (P110029/S042) | Abbott Laboratories | 2023-10-11 |
| ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S051) | Abbott Laboratories, Inc. | 2023-10-11 |
| FoundationOne CDx, F1CDx (P170019/S039) | Foundation Medicine, Inc. | 2023-10-11 |
| ARCHITECT Total PSA, Alinity i Total PSA (P910007/S060) | Abbott Laboratories | 2023-10-11 |
| LifeVest® Wearable Defibrillator (P010030/S167) | Zoll Manufacturing Corporation | 2023-10-11 |
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S040) | Abbott Laboratories | 2023-10-11 |
| MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator (P180025/S010) | Teleflex Medical, LLC | 2023-10-11 |
| LIFEPAK® CR2 Defibrillator (P170018/S018) | Physio-Control, Inc. | 2023-10-11 |
| ARCHITECT HBsAg Next Qualitative / Next Confirmatory (P210003/S007) | Abbott Laboratories | 2023-10-11 |
| ARCHITECT AFP, Alinity i AFP (P120008/S022) | Abbott Laboratories | 2023-10-11 |
| FoundationOne Liquid CDx (F1LCDx) (P190032/S011) | Foundation Medicine, Inc. | 2023-10-11 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S037) | Berlin Heart, Inc. | 2023-10-11 |
| Pipeline Flex Embolization Device, Pipeline Flex Embolization Device with Shield Technology (P100018/S041) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2023-10-10 |
| Endurant Stent Graft System (P100021/S118) | Medtronic Vascular | 2023-10-10 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S013) | W. L. Gore and Associates, Inc. | 2023-10-10 |
| Vercise Genus DBS Systems, Vercise Gevia DBS System, Vercise PC DBS System (P150031/S060) | Boston Scientific Corp | 2023-10-10 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S059) | Medtronic Vascular | 2023-10-10 |
| CT LUCIA 602, CT LUCIA 202 (P100016/S019) | Carl Zeiss Meditec Production, LLC | 2023-10-10 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S455) | Medtronic, Inc. | 2023-10-10 |
| Intellis and Vanta Spinal Cord Stimulation Systems (P840001/S544) | Medtronic Neuromodulation | 2023-10-10 |
| Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S019) | Stryker Leibinger GmbH & Co KG | 2023-10-07 |
| Arctic Front Advance (P100010/S142) | Medtronic Cryocath, LP | 2023-10-06 |
| INFUSE Bone Graft/Medtronic Interbody Fusion Device (P000058/S091) | Medtronic Sofamor Danek USA, Inc. | 2023-10-06 |
| FoundationOne CDx (F1CDx) (P170019/S043) | Foundation Medicine, Inc. | 2023-10-06 |
| INFUSE Bone Graft (P000054/S071) | Medtronic Sofamor Danek USA, Inc. | 2023-10-06 |
| Juvéderm® Voluma® XC (P110033/S070) | Allergan | 2023-10-06 |
| SynchroMed III Pump (P860004/S404) | Medtronic, Inc. | 2023-10-06 |
| QIAGEN therascreen® KRAS RGQ PCR Kit (P110027/S016) | QIAGEN GmbH | 2023-10-06 |
| INFUSE Bone Graft (P050053/S062) | Medtronic, Inc. | 2023-10-06 |
| LifeVest Wearable Defibrillator (P010030/S169) | Zoll Manufacturing Corporation | 2023-10-06 |
| PG ACCOLADE MRI SR SL US, PG ACCOLADE MRI DR SL US, PG ACCOLADE MRI DR EL US, PG PROPONENT MRI SR SL US, PG PROPONENT MR (P150012/S151) | Boston Scientific | 2023-10-06 |
| IsoMed Infusion System (P990034/S044) | Medtronic, Inc. | 2023-10-06 |
| PG VALITUDE CRT-P IS1 EL US, PG VALITUDE CRT-P IS4 EL US, PG VISIONIST CRT-P IS1 EL US, PG VISIONIST CRT-P LV1 EL US, PG (P030005/S233) | Guidant Corp. | 2023-10-06 |
| PG PROPONENT SR SL US, PG PROPONENT DR SL US, PG PROPONENT DR EL US, PG ACCOLADE SR SL US,PG ACCOLADE DR SL US, PG ACCOL (N970003/S288) | Boston Scientific Corp | 2023-10-06 |
| CERAMAX Ceramic Total Hip System (P070026/S110) | DePuy Orthopaedics, Inc. | 2023-10-05 |
| LIAISON® XL Murex HBsAg Qual and LIAISON® XL Murex Control HBsAg. (P190017/S016) | DiaSorin, Inc. | 2023-10-05 |
| Cologuard® (P130017/S056) | Exact Sciences Corporation | 2023-10-05 |
| Eterna SCS System (P010032/S200) | ABBOTT MEDICAL | 2023-10-05 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, WaveWriter A (P030017/S357) | Boston Scientific Corp | 2023-10-05 |
| Elecsys free PSA (P990056/S040) | Roche Diagnostics Corp. | 2023-10-05 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S036) | Berlin Heart, Inc. | 2023-10-05 |
| Elecsys free PSA (P000027/S038) | Roche Diagnostics Corp. | 2023-10-05 |
| Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter (P190019/S023) | Boston Scientific Corporation | 2023-10-05 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S030) | C.R. Bard, Inc. | 2023-10-04 |
| XIENCE Skypoint Everolimus Eluting Coronary Stent System (P110019/S124) | Abbott Vascular | 2023-10-04 |
| cobas® HPV (P190028/S007) | Roche Molecular Systems, Inc. | 2023-10-04 |
| Avitene Microfibrillar Collagen Hemostat (N17600/S037) | Davol Inc., Sub. C. R. Bard, Inc. | 2023-10-04 |
| Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S015) | MicroVention, Inc. | 2023-10-04 |
| MED-EL Cochlear Implant System (P000025/S128) | Med-El Corp. | 2023-10-04 |
| CT LUCIA 621P (P100016/S017) | Carl Zeiss Meditec Production, LLC | 2023-10-02 |
| Oncomine Dx Target Test (P160045/S025) | Life Technologies Corporation | 2023-09-29 |
| HeartMate II Left Ventricular Assist System (P060040/S091) | ABBOTT MEDICAL | 2023-09-29 |
| RHA 2, RHA 3, RHA 4 (P170002/S033) | Teoxane S.A. | 2023-09-29 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories (P010032/S204) | ABBOTT MEDICAL | 2023-09-29 |
| LungFit PH (P200044/S004) | Beyond Air, Inc. | 2023-09-29 |
| Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories (P140009/S089) | ABBOTT MEDICAL | 2023-09-29 |
| TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (P990040/S031) | Cerenovus, Inc. | 2023-09-29 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S833) | Medtronic Cardiac Rhythm Disease Management | 2023-09-29 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S867) | Medtronic Cardiac Rhythm Disease Management | 2023-09-29 |
| CRCDx RAS Mutation Detection Assay Kit (P220005) | Entrogen, Inc. | 2023-09-29 |
| Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories (P150004/S067) | ABBOTT MEDICAL | 2023-09-29 |
| HeartMate 3 Left Ventricular Assist System (P160054/S053) | ABBOTT MEDICAL | 2023-09-29 |
| Thermocool Smarttouch SF (P030031/S134) | Biosense Webster, Inc. | 2023-09-28 |
| NeuroPace® RNS® System (P100026/S087) | NeuroPace, Inc. | 2023-09-28 |
| ROTAPRO and Rotalink Rotational Atherectomy System (P900056/S211) | Boston Scientific Corp | 2023-09-28 |
| LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM (P180045/S012) | DiaSorin, Inc. | 2023-09-28 |
| Thermocool Smarttouch (P040036/S096) | Biosense Webster, Inc. | 2023-09-28 |
| LIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S023) | DiaSorin, Inc. | 2023-09-28 |
| LCS(R) Total Knee System (P830055/S314) | Depuy, Inc. | 2023-09-28 |
| LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S012) | DiaSorin, Inc. | 2023-09-28 |
| LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S013) | DiaSorin, Inc. | 2023-09-28 |
| Alinity i HBsAg Next Qualitative assay, Alinity i HBsAg Next Confirmatory assay (P210003/S006) | Abbott Laboratories | 2023-09-28 |
| LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers (P180039/S014) | DiaSorin, Inc. | 2023-09-28 |
| Cordis® S.M.A.R.T.® CONTROL® Vascular Stent System, Cordis® S.M.A.R.T. RADIANZTM Vascular Stent System (P020036/S050) | Cordis US Corporation | 2023-09-28 |
| LIAISON® XL MUREX anti-HBc and LIAISON® XL MUREX Control anti-HBc (P180038/S015) | DiaSorin, Inc. | 2023-09-28 |
| Biofinity Sphere, Biofinity Torie, Biofinity Multifocal, Biofinity Energys, Biofinity Sphere XR (comfilcon A) Soft (Hydr (P080011/S157) | CooperVision, Inc. | 2023-09-28 |
| LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual (P190017/S015) | DiaSorin, Inc. | 2023-09-28 |
| Cordis® S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent System,Cordis® S.M.A.R.T. RADIANZTM Vascular Stent System (P120002/S025) | Cordis US Corporation | 2023-09-28 |
| Resolute Onyx RX Zotarolimus-Eluting Coronary Stent Systems, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System (P160043/S071) | Medtronic Vascular | 2023-09-28 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, WaveWri (P030017/S366) | Boston Scientific Corp | 2023-09-27 |
| TECNIS Foldable Acrylic IOL with OptiEdge (P990080/S059) | Johnson & Johnson Surgical Vision, Inc. | 2023-09-27 |
| TECNIS Multifocal 3-Piece, TECNIS Foldable Acrylic IOL with OptiEdge (P080010/S024) | Johnson & Johnson Surgical Vision, Inc. | 2023-09-27 |
| Belotero Balance (+) Lidocaine (P090016/S050) | Merz North America, Inc. | 2023-09-27 |
| SENSAR® Soft Acrylic Posterior Chamber IOL (P980040/S165) | Johnson & Johnson Surgical Vision, Inc. | 2023-09-27 |
| Vercise PC, Vercise Gevia, Vercise Genus Deep Brain Stimlation (DBS) Systems (P150031/S061) | Boston Scientific Corp | 2023-09-27 |
| HeartMate 3 Left Ventricular Assist System (P160054/S059) | ABBOTT MEDICAL | 2023-09-27 |
| Trident®, ABC® (P000013/S022) | Howmedica Osteonics Corp. | 2023-09-27 |
| Axonics Sacral Neuromodulation System (P190006/S073) | Boston Scientific Corporation | 2023-09-26 |
| Cross-Seal Suture-Mediated Vascular Closure Device System (P210017) | Terumo Medical Corporation | 2023-09-26 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S406) | Medtronic, Inc. | 2023-09-26 |
| Axonics Sacral Neuromodulation System (P180046/S073) | Boston Scientific Corporation | 2023-09-26 |
| Dimension® TPSA Flex® reagent cartridge (P000021/S045) | Siemens Healthcare Diagnostics | 2023-09-26 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S460) | Medtronic, Inc. | 2023-09-26 |
| Dimension® FPSA Flex® reagent cartridge (P020027/S040) | Siemens Healthcare Diagnostics | 2023-09-26 |