| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S368) | Boston Scientific Corp | 2023-12-29 |
| Occlutech® ASD Occluder and Occlutech® Pistol Pusher (P200032) | Occlutech Holding AG | 2023-12-29 |
| Valitude CRT-P, Valitude X4 CRT-P, Visionist CRT-P, Visionist X4 CRT-P (P030005/S235) | Guidant Corp. | 2023-12-29 |
| Essentio SR, Essento DR, Proponent Dr, Proponent El Dr, Accolade Sr, Accolade Dr, Accolade El Dr, Altrua 2 Sr, Altrua 2 (N970003/S290) | Boston Scientific Corp | 2023-12-29 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S060) | Medtronic Vascular | 2023-12-29 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S067) | Boston Scientific Corp | 2023-12-29 |
| Cardiva VASCADE Family (P120016/S031) | Cardiva Medical, Inc. | 2023-12-29 |
| Essentio MRI SR, Essentio MRI DR, Essentio MRI EL DR, Proponent MRI SR, Proponent MRI DR, Accolade MRI SR, Accoldae MRI (P150012/S154) | Boston Scientific | 2023-12-29 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S468) | Medtronic, Inc. | 2023-12-29 |
| BD PrepMate (P970018/S040) | Bd Diagnostic Systems | 2023-12-28 |
| LifePulse High Frequency Ventilator (P850064/S053) | Bunnell, Inc. | 2023-12-28 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S071) | ABBOTT MEDICAL | 2023-12-28 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S099) | ABBOTT MEDICAL | 2023-12-28 |
| Cardiva VASCADE Family (P120016/S033) | Cardiva Medical, Inc. | 2023-12-28 |
| LifePulse High Frequency Ventilator (P850064/S051) | Bunnell, Inc. | 2023-12-28 |
| Accent, Accent MRI, Assurity, Assurity+, Endurity, Endurity Core (P880086/S331) | ABBOTT MEDICAL | 2023-12-27 |
| Microny (P970013/S093) | ABBOTT MEDICAL | 2023-12-27 |
| Endurity MRI, Assurity MRI (P140033/S082) | ABBOTT MEDICAL | 2023-12-27 |
| Quadra Assura, Unify, Unify Assura, Unify Quadra, Avant, Gallant, Entrant, Neutrino NxT (P030054/S415) | ABBOTT MEDICAL | 2023-12-27 |
| Ellipse, Fortify, Fortify Assura, Quadra Assura MP, Avant, Gallant, Entrant, Neutrino NxT (P910023/S460) | ABBOTT MEDICAL | 2023-12-27 |
| Restylane® Eyelight Injectable Gel (P040024/S139) | Q-Med AB | 2023-12-27 |
| Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional) (P030035/S197) | ABBOTT MEDICAL | 2023-12-27 |
| Duo Venous Stent System (P230021) | Philips Image Guided Therapy Corporation | 2023-12-26 |
| WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli (P130013/S060) | Boston Scientific Corp | 2023-12-23 |
| Medtronic CoreValve System, Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System (P130021/S151) | Medtronic, Inc. | 2023-12-23 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S096) | ABBOTT MEDICAL | 2023-12-23 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S066) | ABBOTT MEDICAL | 2023-12-23 |
| EXOSEAL Vascular Closure Device (P100013/S027) | Cordis US Corporation | 2023-12-23 |
| CraniSeal Dural Sealant (P220014/S001) | Pramand, LLC | 2023-12-23 |
| TECNIS Odyssey Toric II Intraocular Lens (IOL) With TECNIS Simplicity Delivery System, Models DRT150, DRT225, DRT300, DR (P980040/S159) | Johnson & Johnson Surgical Vision, Inc. | 2023-12-22 |
| TECNIS Symfony Extended Range Of Vision Intraocular Lens (P980040/S161) | Johnson & Johnson Surgical Vision, Inc. | 2023-12-22 |
| therascreen FGFR RGQ RT-PCR Kit (P180043/S006) | QIAGEN GmbH | 2023-12-22 |
| Barostim System (P180050/S009) | Cvrx, Inc. | 2023-12-22 |
| LIFEPAK® 15 monitor/defibrillator (P160026/S042) | Physio-Control, Inc. | 2023-12-22 |
| LCS Total Knee System, ATTUNE Revision Cones (P830055/S316) | Depuy, Inc. | 2023-12-22 |
| MED-EL Cochlear Implant System (P000025/S130) | Med-El Corp. | 2023-12-22 |
| NexGen® LPS-Flex / LPS-Mobile Bearing Knee (P060037/S086) | Zimmer, Inc. | 2023-12-22 |
| Tula System (P190016/S008) | Tusker Medical, Inc. | 2023-12-22 |
| Roche cobas EFGR Mutation Test, v2.0 (P120019/S038) | Roche | 2023-12-21 |
| Powerheart® G5 AED (P160033/S010) | ZOLL Medical Corporation | 2023-12-21 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S028) | Biotronik AG | 2023-12-21 |
| EXOGEN® Ultrasound Bone Healing System (P900009/S049) | Bioventus, LLC | 2023-12-21 |
| Roche cobas KRAS Mutation Test (P140023/S028) | Roche Molecular Systems, Inc. | 2023-12-21 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella 5.5 with SmartAssist Systems (P140003/S117) | Abiomed, Inc. | 2023-12-21 |
| Roche cobas® EZH2 Mutation Test (P200014/S008) | Roche Molecular System, Inc. | 2023-12-21 |
| Rapid fFN for the TLiIQ System (P920048/S025) | Hologic, Inc. | 2023-12-21 |
| Roche cobas BRAF V600 Mutation Test (P110020/S041) | Roche Molecular Systems, Inc. | 2023-12-21 |
| Impella RP, Impella RP with SmartAssist and Impella RP Flex Systems (P170011/S052) | Abiomed, Inc. | 2023-12-21 |
| OPRA Implant System (P190009/S004) | Integrum AB | 2023-12-21 |
| Biofinity Sphere, Biofinity Toric (P080011/S158) | CooperVision, Inc. | 2023-12-20 |
| CraniSeal Dural Sealant (P220014/S002) | Pramand, LLC | 2023-12-20 |
| Glaukos® Corporation iStent inject® W Trabecular Micro-Bypass System (P170043/S018) | Glaukos Corporation | 2023-12-20 |
| Trident Ceramic System (P000013/S021) | Howmedica Osteonics Corp. | 2023-12-20 |
| LINX Reflux Management System (P100049/S036) | Torax Medical | 2023-12-19 |
| LCS® Total Knee System (P830055/S310) | Depuy, Inc. | 2023-12-19 |
| Proclaim DRG IPG (Model 3664), DRG 50cm leads (models MN10450-50, MN10450-50A), port plug (Model 7108), lead anchor (P150004/S063) | ABBOTT MEDICAL | 2023-12-19 |
| Charger, Model 16000 (P010032/S206) | ABBOTT MEDICAL | 2023-12-19 |
| Saluda Medical Evoke SCS System (P190002/S018) | Saluda Medical Pty, Ltd. | 2023-12-19 |
| Trident(R), ABC(R) (P000013/S023) | Howmedica Osteonics Corp. | 2023-12-19 |
| HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (P160029/S020) | Philips Medical Systems, Inc. | 2023-12-19 |
| AvertD and AvertD Buccal Sample Collection Kit (P230032) | AutoGenomics, Inc. | 2023-12-19 |
| Cermax® Ceramic Total Hip System (P070026/S109) | DePuy Orthopaedics, Inc. | 2023-12-19 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S062) | Alcon Research, Ltd. | 2023-12-18 |
| ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA (P950021/S027) | Siemens Healthcare Diagnostics | 2023-12-18 |
| ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA (P990055/S026) | Siemens Healthcare Diagnostics | 2023-12-18 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System, DISCOVISC Ophthalmic Viscosurgical (P840064/S083) | Alcon Laboratories | 2023-12-18 |
| Epic, Epic Supra, Epic Plus, Epic Plus Supra, Epic Max, Portico, Navitor, and Navitor Titan Tissue Heart Valves (P040021/S055) | ABBOTT MEDICAL | 2023-12-18 |
| InterStim Therapy System, Verify Evaluation System (P080025/S285) | Medtronic Neuromodulation | 2023-12-18 |
| Epic, Epic Supra, Epic Plus, Epic Plus Supra, Epic Max, Portico, Navitor, and Navitor Titan Tissue Heart Valves (P190023/S017) | ABBOTT MEDICAL | 2023-12-18 |
| Bulkamid Urethral Bulking System (P170023/S016) | Boston Scientific Corporation | 2023-12-18 |
| Clareon PanOptix Pro Trifocal Intraocular Lens (IOL), Clareon PanOptix Pro Trifocal Toric IOLs, Clareon PanOptix Pro Tr (P190018/S029) | Alcon Laboratories, LLC | 2023-12-18 |
| ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA (P930036/S022) | Siemens Healthcare Diagnostics, Inc. | 2023-12-18 |
| Minerva Endometrial Ablation System (P140013/S014) | Axora Medical, Inc. | 2023-12-18 |
| TheraSphere (P200029/S007) | Boston Scientific Corporation | 2023-12-18 |
| Filshie Clip System (P920046/S013) | Femcare , Ltd. | 2023-12-18 |
| InterStim Therapy System, Verify Evaluation System (P970004/S390) | Medtronic Neuromodulation | 2023-12-18 |
| Coaxial Umbilical Cable - single pack, Coaxial Umbilical Cable - 12 pack (P020045/S107) | Medtronic Cryocath, LP | 2023-12-15 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S009) | Cook Medical Incorporated | 2023-12-15 |
| Xience Skypoint Everolimus Eluting Coronary Stent System (XIENCE Skypoint) , XIENCE PROs Everolimus Eluting Coronary Ste (P110019/S130) | Abbott Vascular | 2023-12-15 |
| LIFEPAK® 15 monitor/defibrillator (P160026/S044) | Physio-Control, Inc. | 2023-12-15 |
| Lotrafilcon B soft contact lenses for daily and extended wear (P010019/S084) | Alcon Laboratories, Inc. | 2023-12-15 |
| I-FACTOR Peptide Enhanced Bone Graft (P140019/S010) | Cerapedics, LLC | 2023-12-15 |
| QuantiFERON®-TB Gold Plus Test (P010033/S049) | Qiagen | 2023-12-15 |
| Aurora EV ICD (P220012/S009) | Medtronic, Inc. | 2023-12-15 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S420) | Medtronic, Inc. | 2023-12-15 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG (P980035/S768) | Medtronic, Inc. | 2023-12-15 |
| Model 2740 and 2740C Cable Interference (P130008/S101) | Inspire Medical Systems | 2023-12-15 |
| Patient Cable (P820003/S141) | Medtronic Cardiac Rhythm Disease Management | 2023-12-15 |
| 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/S842) | Medtronic Cardiac Rhythm Disease Management | 2023-12-15 |
| 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/S876) | Medtronic Cardiac Rhythm Disease Management | 2023-12-15 |
| Zenith® Dissection Endovascular System (P180001/S010) | William Cook Europe Aps | 2023-12-15 |
| Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System (P960043/S121) | Abbott Vascular, Inc. | 2023-12-14 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S042) | Abbott Laboratories | 2023-12-14 |
| LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device (P220024/S004) | Advanced Medical Solutions Limited | 2023-12-14 |
| ARCHITECT HBsAg Next Qualitative / Alinity i HBsAg Next Qualitative, ARCHITECT HBsAg NEXT Confirmatory / Alinity i HBsAg (P210003/S010) | Abbott Laboratories | 2023-12-14 |
| Zenith® Fenestrated AAA Endovascular Graft, Zenith® Flex AAA Endovascular System (P020018/S061) | Cook, Inc. | 2023-12-14 |
| ARCHITECT HBsAg Qualitative / Alinity i HBsAg Qualitative II (P110029/S049) | Abbott Laboratories | 2023-12-14 |
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S044) | Abbott Laboratories | 2023-12-14 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S054) | Abbott Laboratories | 2023-12-14 |
| COBAS® AmpliPrep® / COBAS® TaqMan® HBV Test, v2.0 (P050028/S091) | Roche Molecular Systems, Inc. | 2023-12-14 |