| HeartMate II Left Ventricular Assist System (P060040/S097) | ABBOTT MEDICAL | 2023-12-14 |
| cobas® KRAS Mutation Test (P140023/S027) | Roche Molecular Systems, Inc. | 2023-12-14 |
| cobas® HPV (P190028/S014) | Roche Molecular Systems, Inc. | 2023-12-14 |
| ARCHITECT AFP / Alinity i AFP (P120008/S027) | Abbott Laboratories | 2023-12-14 |
| cobas® HPV (P100020/S058) | Roche Molecular Systems, Inc. | 2023-12-14 |
| cobas® CMV (P160041/S040) | Roche Molecular Systems, Inc. | 2023-12-14 |
| cobas® BRAF V600 Mutation Test (P110020/S040) | Roche Molecular Systems, Inc. | 2023-12-14 |
| cobas® HBV (P150014/S047) | Roche Molecular Systems, Inc. | 2023-12-14 |
| SURGICEL® Absorbable Hemostats (SURGICEL® POWDER) (N12159/S108) | ETHICON, Inc. | 2023-12-14 |
| ORBERA Intragastric Balloon (IGB) System, Endoline Punc (P140008/S025) | Boston Scientific Corporation | 2023-12-14 |
| COBAS® AmpliPrep® / COBAS® TaqMan® HBV Test, v2.0 (P050028/S089) | Roche Molecular Systems, Inc. | 2023-12-14 |
| HeartMate 3 Left Ventricular Assist System (P160054/S068) | ABBOTT MEDICAL | 2023-12-14 |
| DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (OAS) (P130005/S040) | Cardiovascular Systems, Inc. | 2023-12-14 |
| cobas® EZH2 Mutation Test (P200014/S007) | Roche Molecular System, Inc. | 2023-12-14 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S065) | Abbott Laboratories | 2023-12-14 |
| COBAS® AmpliPrep® / COBAS® TaqMan® CMV Test (P110037/S060) | Roche Molecular Systems, Inc. | 2023-12-14 |
| cobas HPV (P190028/S013) | Roche Molecular Systems, Inc. | 2023-12-14 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S051) | Edwards Lifesciences, LLC | 2023-12-14 |
| ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S058) | Abbott Laboratories, Inc. | 2023-12-14 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S038) | Berlin Heart, Inc. | 2023-12-14 |
| Zenith® Dissection Endovascular System (P180001/S008) | William Cook Europe Aps | 2023-12-14 |
| Patient Cable (P820003/S142) | Medtronic Cardiac Rhythm Disease Management | 2023-12-14 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S007) | Cook Medical Incorporated | 2023-12-14 |
| COBAS® AmpliPrep® / COBAS® TaqMan® CMV Test (P110037/S061) | Roche Molecular Systems, Inc. | 2023-12-14 |
| cobas® HBV (P150014/S048) | Roche Molecular Systems, Inc. | 2023-12-14 |
| cobas® EGFR Mutation Test, v2.0 (P120019/S037) | Roche | 2023-12-14 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES (P140031/S169) | Edwards Lifesciences, LLC | 2023-12-14 |
| LINX Reflux Management System (P100049/S035) | Torax Medical | 2023-12-14 |
| cobas® CMV (P160041/S039) | Roche Molecular Systems, Inc. | 2023-12-14 |
| CapSureFix MRI Lead (P090013/S330) | Medtronic, Inc. | 2023-12-13 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S181) | Medtronic, Inc. | 2023-12-13 |
| TREO Abdominal Stent-Graft System (P190015/S013) | Bolton Medical, Inc. | 2023-12-13 |
| CapSureFix Novus Lead (P930039/S256) | Medtronic, Inc. | 2023-12-13 |
| Nucleus® Hybrid Cochlear Implant (P130016/S055) | Cochlear Americas | 2023-12-13 |
| Myocardial Pacing Lead (P120017/S035) | Medtronic, Inc. | 2023-12-13 |
| PSW 2303.U, NEO 2303.U (P000009/S105) | Biotronik, Inc. | 2023-12-13 |
| CapSure Epicardial Pacing Lead (P950024/S110) | Medtronic, Inc. | 2023-12-13 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S529) | Medtronic, Inc. | 2023-12-13 |
| R3 Delta Ceramic Hip System (P150030/S038) | Smith & Nephew, Inc. | 2023-12-13 |
| PSW 2303.U, NEO 2303.U (P070008/S151) | Biotronik, Inc. | 2023-12-13 |
| Aurora EV ICD (P220012/S008) | Medtronic, Inc. | 2023-12-13 |
| Zenith Alpha Thoracic Endovascular Graft (ZTA) (P140016/S008) | Cook Medical Incorporated | 2023-12-13 |
| DF-1 Connector Port Pin Plug, HV Splitter/Adopter Kit, Sprint Quattro Lead (P920015/S283) | Medtronic, Inc. | 2023-12-13 |
| Lead EV ICD Extravascular - Epsila (P220012/S005) | Medtronic, Inc. | 2023-12-13 |
| Zenith® Fenestrated AAA Endovascular Graft (ZFEN), Zenith® Flex AAA Endovascular System (P020018/S062) | Cook, Inc. | 2023-12-13 |
| Nucleus® 24 Cochlear Implant System (P970051/S224) | Cochlear Americas | 2023-12-13 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S189) | Boston Scientific Corporation | 2023-12-13 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRT Quad CRT-D, Cobalt (P010031/S841) | Medtronic Cardiac Rhythm Disease Management | 2023-12-13 |
| RHA® Redensity Mepi, RHA®2 Mepi, RHA®3 Mepi, RHA®4 Mepi (P170002/S034) | Teoxane S.A. | 2023-12-13 |
| Nucleus® Auditory Brainstem Implant (P000015/S052) | Cochlear Americas | 2023-12-13 |
| 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/S875) | Medtronic Cardiac Rhythm Disease Management | 2023-12-13 |
| PSW 2303.U, NEO 2303.U (P050023/S177) | Biotronik, Inc. | 2023-12-13 |
| Zenith® Dissection Endovascular System (P180001/S009) | William Cook Europe Aps | 2023-12-13 |
| 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/S839) | Medtronic Cardiac Rhythm Disease Management | 2023-12-13 |
| PSW 2303.U, NEO 2303.U (P950037/S252) | Biotronik, Inc. | 2023-12-13 |
| Myopore Sutureless Myocardial Pacing Lead (P130012/S015) | Great Batch Medical | 2023-12-13 |
| Attain Ability Lead (P080006/S182) | Medtronic, Inc. | 2023-12-13 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra (P980035/S767) | Medtronic, Inc. | 2023-12-13 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, E (P980016/S873) | Medtronic Cardiac Rhythm Disease Management | 2023-12-13 |
| PulseSelect Pulsed Field Ablation (PFA) system (P230017) | Medtronic, Inc. | 2023-12-13 |
| Blazer Open-Irrigated Ablation Catheter (P150005/S080) | Boston Scientific Corp | 2023-12-12 |
| Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec (P840001/S550) | Medtronic Neuromodulation | 2023-12-12 |
| Chilli Cooled Rf Ablation System (P980003/S097) | Boston Scientific Corp | 2023-12-12 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S287) | Medtronic Neuromodulation | 2023-12-12 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S392) | Medtronic Neuromodulation | 2023-12-12 |
| Rotablator Rotational Atherectomy System (P900056/S212) | Boston Scientific Corp | 2023-12-12 |
| Master Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S462) | Medtronic, Inc. | 2023-12-12 |
| POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories (P220032/S002) | Boston Scientific Corporation | 2023-12-12 |
| Evoke SCS System (P190002/S022) | Saluda Medical Pty, Ltd. | 2023-12-12 |
| T-SPOT. TB TEST (P070006/S020) | Oxford Immunotec, Ltd. | 2023-12-12 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S025) | Boston Scientific Corporation | 2023-12-12 |
| WOLVERINE Coronary Cutting Balloon (P950020/S142) | Boston Scientific Corp | 2023-12-12 |
| PROMUS Element Plus and Promus PREMIER and Promus ELITE Everolimus-Eluting Stent System (P110010/S212) | Boston Scientific Corp | 2023-12-12 |
| REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire (P130030/S077) | Boston Scientific Corp | 2023-12-12 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S416) | Medtronic, Inc. | 2023-12-12 |
| ROTAPRO Rotational Atherectomy System (P900056/S213) | Boston Scientific Corp | 2023-12-12 |
| Nevro Corp Senza® Spinal Cord Stimulation (SCS) System (P130022/S054) | Nevro Corporation | 2023-12-12 |
| Blazer II Cardiac Ablation System and Cable (P920047/S134) | Boston Scientific Corp | 2023-12-12 |
| Perfluoron (P950018/S027) | Alcon Laboratories | 2023-12-12 |
| Express® SD Renal Monorail Premounted Stent System (P060006/S109) | Boston Scientific Corp | 2023-12-12 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S142) | Boston Scientific | 2023-12-12 |
| Lap-Band Adjustable Gastric Banding System (P000008/S048) | Medtimo, Inc. | 2023-12-12 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| EDWARDS INTUITY Elite Valve (P150036/S071) | Edwards Lifesciences, LLC | 2023-12-11 |
| Juvéderm Voluma XC (Voluma XC), Juvéderm Vollure XC (Vollure XC), Juvéderm Volbella XC (Volbella XC), Juvéderm Volux XC (P110033/S080) | Allergan | 2023-12-11 |
| Carpentier-Edwards PERIMOUNT Aortic and Mitral Surgical Heart Valves (P860057/S214) | Edwards Lifesciences, LLC | 2023-12-11 |
| AMS 700 Inflatable Penile Prosthesis (IPP (N970012/S201) | Boston Scientific Corp | 2023-12-11 |
| Juvéderm Ultra XC (Ultra XC), Juvéderm Ultra Plus XC (Ultra Plus XC) (P050047/S092) | Allergan | 2023-12-11 |
| MynxGrip Vascular Closure Device and Mynx Control Vascular Closure Device (VCD) (P040044/S096) | Cordis US Corporation | 2023-12-11 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S167) | Edwards Lifesciences, LLC | 2023-12-11 |
| AMS 800 Artificial Urinary Sphincter (AUS) (P000053/S133) | Boston Scientific Corp | 2023-12-11 |
| EPi-Sense Guided Coagulation System and EPi-Sense ST Coagulation System (P200002/S008) | AtriCure, Inc. | 2023-12-11 |
| LifeVest® Wearable Defibrillator (P010030/S168) | Zoll Manufacturing Corporation | 2023-12-11 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S057) | ETHICON, Inc. | 2023-12-11 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P200015/S049) | Edwards Lifesciences, LLC | 2023-12-11 |
| 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, Compia (P010031/S843) | Medtronic Cardiac Rhythm Disease Management | 2023-12-10 |
| Aurora EV ICD (P220012/S010) | Medtronic, Inc. | 2023-12-10 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI VR ICD, Mirro MRI DR ICD, (P980016/S877) | Medtronic Cardiac Rhythm Disease Management | 2023-12-10 |
| GORE® VIATORR® TIPS Endoprosthesis (P040027/S094) | W. L. Gore & Associates, Inc. | 2023-12-08 |
| Mater Water Vapor System - Model # GEA-SYS-16-0500, Mara Water Vapor Probe Kit - Model # DDK-16-050, Mara Console - Mode (P160047/S034) | CooperSurgical, Inc. | 2023-12-08 |