| Harmony Transcatheter Pulmonary Valve, Harmony Delivery Catheter System (P200046/S015) | Medtronic, Inc. | 2023-02-12 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S029) | Smith & Nephew, Inc. | 2023-02-12 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S030) | Smith & Nephew, Inc. | 2023-02-12 |
| Allure, Allure Quadra, Quadra Allure, Quadra Allure MP (P030035/S193) | ABBOTT MEDICAL | 2023-02-10 |
| Fortify, Fortify Assura, Ellipse, Neutrino NxT VR, Gallant VR, Entrant VR, Neutrino NxT DR, Gallant DR, Entrant DR, Avan (P910023/S450) | ABBOTT MEDICAL | 2023-02-10 |
| Unify ,Unify Assura, Quadra Assura, Quadra Assura MP, Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF, Neutrino NxT (P030054/S404) | ABBOTT MEDICAL | 2023-02-10 |
| Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR (P910023/S452) | ABBOTT MEDICAL | 2023-02-10 |
| Oncomine Dx Target Test (P160045/S040) | Life Technologies Corporation | 2023-02-10 |
| Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF (P030054/S406) | ABBOTT MEDICAL | 2023-02-10 |
| Assurity MRI, Endurity MRI, (P140033/S078) | ABBOTT MEDICAL | 2023-02-10 |
| NeuroPace® RNS® System (P100026/S092) | NeuroPace, Inc. | 2023-02-10 |
| Assurity, Assurity+, Endurity (P880086/S327) | ABBOTT MEDICAL | 2023-02-10 |
| AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone (N970012/S195) | Boston Scientific Corp | 2023-02-10 |
| BD Onclarity HPV Assay (P160037/S008) | Becton, Dickinson and Company | 2023-02-09 |
| LCS® Total Knee System (P830055/S304) | Depuy, Inc. | 2023-02-09 |
| ANGIO-SEAL VIP Vascular Closure Device (P930038/S099) | Terumo Medical Corporation | 2023-02-09 |
| CERAMAX® Ceramic Total Hip System (P070026/S104) | DePuy Orthopaedics, Inc. | 2023-02-09 |
| Evera S, Evera XT, Maximo II, Protecta, Protecta XT, Secura, Virtuoso II, Cobalt, Cobalt XT, Crome, Crome XT (P980016/S842) | Medtronic Cardiac Rhythm Disease Management | 2023-02-08 |
| Brava, Brava Quad, Concerto II, Consulta, Maximo II, Protecta, Protecta XT, Viva Quad C, Viva Quad S, Viva Quad XT, Viva (P010031/S809) | Medtronic Cardiac Rhythm Disease Management | 2023-02-08 |
| Instrument Command Library (ICL), Device Command Library (DCL) (P890003/S459) | Medtronic, Inc. | 2023-02-08 |
| Myopore® Sutureless Myocardial Pacing Lead (P130012/S013) | Great Batch Medical | 2023-02-07 |
| TRIDYNE Vascular Sealant (P150016/S023) | Neomend, Inc. | 2023-02-07 |
| Axonics Sacral Neuromodulation System (P190006/S054) | Boston Scientific Corporation | 2023-02-07 |
| Axonics Sacral Neuromodulation System (P180046/S054) | Boston Scientific Corporation | 2023-02-07 |
| Demipulse Generator; Demipulse Duo Generator, AspireSR Generator, SenTiva Generator; SenTiva Duo Generator, Symmetr (P970003/S238) | LivaNova USA, Inc. | 2023-02-07 |
| Portico (P190023/S012) | ABBOTT MEDICAL | 2023-02-07 |
| Integra Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template (P900033/S104) | Integra Lifesciences Corp. | 2023-02-07 |
| CT LUCIA 621P (P100016/S009) | Carl Zeiss Meditec Production, LLC | 2023-02-07 |
| PROGEL Pleural Air Leak Sealant (P010047/S068) | Neomend, Inc. | 2023-02-07 |
| VENTANA PD-L1 (SP142) Assay (P160002/S020) | Ventana Medical Systems, Inc. | 2023-02-07 |
| LCS® Total Knee System (P830055/S305) | Depuy, Inc. | 2023-02-06 |
| Attain StarFix Lead (P060039/S113) | Medtronic, Inc. | 2023-02-06 |
| 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/S814) | Medtronic Cardiac Rhythm Disease Management | 2023-02-06 |
| LeukoStrat® CDx FL T3 Mutation Assay (P160040/S012) | Invivoscribe Technologies, Inc. | 2023-02-06 |
| 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/S848) | Medtronic Cardiac Rhythm Disease Management | 2023-02-06 |
| 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/S740) | Medtronic, Inc. | 2023-02-06 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S174) | Medtronic, Inc. | 2023-02-06 |
| ADVIA Centaur® and Atellica IM Hepatitis B Core IgM (AHBcM) Assay (P030040/S022) | Siemens Healthcare Diagnostics | 2023-02-06 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead (P010015/S515) | Medtronic, Inc. | 2023-02-06 |
| LifePulse High Frequency Ventilator (P850064/S049) | Bunnell, Inc. | 2023-02-06 |
| Consulta CRT-P, Percepta Bioplar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S514) | Medtronic, Inc. | 2023-02-06 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG (P980035/S739) | Medtronic, Inc. | 2023-02-03 |
| Straumann Emdogain (P930021/S030) | The Straumann Company | 2023-02-03 |
| 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/S847) | Medtronic Cardiac Rhythm Disease Management | 2023-02-03 |
| Consulta CRT-P, Syncra CRT-P (P010015/S513) | Medtronic, Inc. | 2023-02-03 |
| 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/S813) | Medtronic Cardiac Rhythm Disease Management | 2023-02-03 |
| Covera Vascular Covered Stent (P170042/S012) | C.R. Bard, Inc. | 2023-02-02 |
| Shockwave C2 Intravascular Lithotripsy (IVL) Catheter, VL Generator and Connector Cable Kit, IVL Connector Cable (Replac (P200039/S009) | Shockwave Medical, Inc. | 2023-02-02 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |
| LifeStent 5F Vascular Stent Systems (P070014/S064) | Bard Peripheral Vascular, Inc. | 2023-02-02 |
| Activa® Deep Brain Stimulation Therapy System (P960009/S446) | Medtronic, Inc. | 2023-02-02 |
| Restore and Itrel® Spinal Cord Stimulation Systems (P840001/S536) | Medtronic Neuromodulation | 2023-02-02 |
| HeartWare® Ventricular Assist System, HeartWare® System (P100047/S205) | Medtronic | 2023-02-02 |
| Venovo Venous Stent System (P180037/S012) | Bard Peripheral Vascular, Inc. | 2023-02-02 |
| Rotablator and ROTAPRO Rotational Atherectomy System (P900056/S204) | Boston Scientific Corp | 2023-02-02 |
| LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software (P180047/S021) | DiaSorin, Inc. | 2023-02-01 |
| IDEAL IMPLANT® Structured Breast Implant (P120011/S023) | Bimini Health Tech | 2023-02-01 |
| Synergy XD Everolimus-Eluting Platinum Chromium Coronary Stent System, Synergy Megatron Everolimus-Eluting Platinum Chro (P150003/S088) | Boston Scientific Corporation | 2023-02-01 |
| Oncomine Dx Target Test (P160045/S038) | Life Technologies Corporation | 2023-02-01 |
| Medtronic CoreValue Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medt (P130021/S130) | Medtronic, Inc. | 2023-02-01 |
| Axonics Sacral Neuromodulation System (P180046/S064) | Boston Scientific Corporation | 2023-02-01 |
| Carotid Wallstent Monorail Endoprosthesis (P050019/S035) | Boston Scientific Corp | 2023-02-01 |
| LCS® Total Knee System (P830055/S303) | Depuy, Inc. | 2023-02-01 |
| Axonics Sacral Neuromodulation System (P190006/S064) | Boston Scientific Corporation | 2023-02-01 |
| SURGIFOAM® Absorbable Gelatin Sponge, SURGIFOAM® Absorbable Gelatin Powder, SURGIFOAM® Absorbable Gelatin Powder Kit, SU (P990004/S056) | Ferrosan Meidcal Devices A/S | 2023-01-31 |
| Absolute Pro Vascular Self-Expanding Stent System (P110028/S023) | Abbott Vascular, Inc. | 2023-01-31 |
| XACT Carotid Stent System (P040038/S041) | Abbott Vascular, Inc. | 2023-01-31 |
| Light Adjustable Lens, Light Delivery Device (P160055/S022) | Rxsight, Inc. | 2023-01-31 |
| Supera Peripheral Stent System (P120020/S030) | Abbott Vascular (Idef Technologies Inc) | 2023-01-31 |
| MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System, MitraClip G4 Clip Delivery System (P100009/S051) | ABBOTT MEDICAL | 2023-01-31 |
| RX Acculink Carotid Stent System (P040012/S064) | Abbott Vascular | 2023-01-31 |
| Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System, Prostar X (P960043/S120) | Abbott Vascular, Inc. | 2023-01-31 |
| StarClose SE Vascular Closure System (P050007/S043) | Abbott Vascular Devices | 2023-01-31 |
| ARCHITECT AFP / Alinity i AFP (P120008/S021) | Abbott Laboratories | 2023-01-30 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S059) | Abbott Laboratories | 2023-01-30 |
| LifeVest® Wearable Defibrillator (P010030/S161) | Zoll Manufacturing Corporation | 2023-01-30 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S037) | Abbott Laboratories | 2023-01-30 |
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S039) | Abbott Laboratories | 2023-01-30 |
| Axonics Sacral Neuromodulation System (P190006/S056) | Boston Scientific Corporation | 2023-01-30 |
| ARCHITECT HBsAg Next Qualitative / Next Confirmatory (P210003/S005) | Abbott Laboratories | 2023-01-30 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S048) | Abbott Laboratories | 2023-01-30 |
| LCS(R) TOTAL KNEE SYSTEM (P830055/S302) | Depuy, Inc. | 2023-01-30 |
| ARCHITECT HBsAg Qualitative / HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II / HBsAg Qualitative II Conf (P110029/S041) | Abbott Laboratories | 2023-01-30 |
| Axonics Sacral Neuromodulation System (P180046/S056) | Boston Scientific Corporation | 2023-01-30 |
| ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S049) | Abbott Laboratories, Inc. | 2023-01-30 |
| CINtec PLUS Cytology (P190024/S009) | Ventana Medical Systems, Inc. | 2023-01-30 |
| Evolut FX Delivery Catheter System (P130021/S131) | Medtronic, Inc. | 2023-01-29 |
| Nevro Corp Senza Spinal Cord Stimulation (SCS) System (P130022/S045) | Nevro Corporation | 2023-01-27 |
| Masters Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Valved Graft with Hemashield graft technology (C (P810002/S116) | ABBOTT MEDICAL | 2023-01-27 |
| Guardant360 CDx (P200010/S010) | Guardant Health, Inc. | 2023-01-27 |
| BRACAnalysis CDx® (P140020/S026) | Myriad Genetic Laboratories | 2023-01-27 |
| 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, E (P980016/S846) | Medtronic Cardiac Rhythm Disease Management | 2023-01-26 |
| ORSIRO Mission Sirolimus Eluting Coronary Stent System (P170030/S025) | Biotronik AG | 2023-01-26 |
| 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/S812) | Medtronic Cardiac Rhythm Disease Management | 2023-01-26 |
| RHA® Redensity, RHA ®2, RHA ®3, RHA ®4 dermal fillers (P170002/S025) | Teoxane S.A. | 2023-01-26 |
| DuraSeal Dural Sealant System (P040034/S033) | Integra LifeSciences Corporation | 2023-01-25 |
| DuraSeal Exact Spine Sealant System (P080013/S022) | Integra LifeSciences Corporation | 2023-01-25 |
| Artegraft Collagen Vascular Graft (N16837/S029) | LeMaitre Vascular, Inc. | 2023-01-25 |
| VITROS Anti-HBc IgM (P030026/S037) | Ortho-Clinical Diagnostics, Inc. | 2023-01-24 |
| QUANTIFERON®-TB Gold Plus Test (P010033/S048) | Qiagen | 2023-01-24 |