| INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR, MOMENTUM EL ICD VR, MOMENTUM EL (P960040/S498) | Boston Scientific | 2023-11-21 |
| MISAGO® RX Self-expanding Peripheral Stent (P140002/S027) | Terumo Medical Corporation | 2023-11-21 |
| SICD Gen 2, SICD MRI (P110042/S191) | Boston Scientific Corporation | 2023-11-21 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S059) | Abbott Diabetes Care, Inc. | 2023-11-21 |
| XIENCE Sierra Everolimus Eluting Coronary Stent System (XIENCE Sierra), XIENCE Skypoint Everolimus Eluting Coronary Sten (P110019/S129) | Abbott Vascular | 2023-11-21 |
| Perfluoron (P950018/S025) | Alcon Laboratories | 2023-11-21 |
| LifeVest Wearable Defibrillator Models 4000 and 5100 (P010030/S171) | Zoll Manufacturing Corporation | 2023-11-21 |
| EluNIR-PERL Ridaforolimus Eluting Coronary Stent System (P170008/S046) | Medinol, Ltd. | 2023-11-21 |
| NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S085) | Zimmer, Inc. | 2023-11-21 |
| Protégé GPS Self-Expanding Peripheral Stent System (P060001/S038) | Medtronic Vascular, Inc. | 2023-11-21 |
| FreeStyle Libre 14 day Flash Glucose Monitoring System (P160030/S055) | Abbott Diabetes Care, Inc. | 2023-11-21 |
| EverFlex Self-Expanding Peripheral Stent System (P110023/S041) | Medtronic Vascular, Inc. | 2023-11-21 |
| 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/S762) | Medtronic, Inc. | 2023-11-20 |
| Thoraflex Hybrid (P210006/S005) | Vascutek, Ltd. | 2023-11-20 |
| Edwards Commander Delivery System (P140031/S166) | Edwards Lifesciences, LLC | 2023-11-20 |
| 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/S870) | Medtronic Cardiac Rhythm Disease Management | 2023-11-20 |
| BD Onclarity HPV Assay (P160037/S018) | Becton, Dickinson and Company | 2023-11-20 |
| OrganOx metra® System (P200035/S007) | Organox Limited | 2023-11-20 |
| 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/S836) | Medtronic Cardiac Rhythm Disease Management | 2023-11-20 |
| MitraClip G4 Clip Delivery System (P100009/S055) | ABBOTT MEDICAL | 2023-11-20 |
| Edwards Commander Delivery System (P200015/S048) | Edwards Lifesciences, LLC | 2023-11-20 |
| EV ICD - Aurora (P220012/S002) | Medtronic, Inc. | 2023-11-20 |
| Ideal Implant Structured Breast implant (P120011/S027) | Bimini Health Tech | 2023-11-18 |
| CALCIVIS Imaging System (P170029/S002) | Calcivis Limited | 2023-11-17 |
| Nucleus Hybrid L24 Cochlear Implant System (P130016/S052) | Cochlear Americas | 2023-11-17 |
| POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories (P220032/S001) | Boston Scientific Corporation | 2023-11-17 |
| LCS Total Knee System (P830055/S309) | Depuy, Inc. | 2023-11-17 |
| Inspire Upper Airway Stimulation (UAS) (P130008/S104) | Inspire Medical Systems | 2023-11-17 |
| HiResolution Bionic Ear System (P960058/S159) | Advanced Bionics | 2023-11-17 |
| Symplicity Spyral Renal Denervation System (P220026) | Medtronic, Inc. | 2023-11-17 |
| Attain Performa Lead (P080006/S180) | Medtronic, Inc. | 2023-11-17 |
| GORE TAG Thoracic Branch Endoprosthesis (TBE) Side Branch (P210032/S012) | W. L. Gore & Associates, Inc. | 2023-11-17 |
| HeartMate II Left Ventricular Assist System (P060040/S095) | ABBOTT MEDICAL | 2023-11-16 |
| HeartMate 3 Left Ventricular Assist System (P160054/S065) | ABBOTT MEDICAL | 2023-11-16 |
| Cerene® Cryotherapy Device (P180032/S015) | Channel Medsystems, Inc. | 2023-11-16 |
| FoundationOne CDx (F1CDx) (P170019/S048) | Foundation Medicine, Inc. | 2023-11-16 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S039) | W. L. Gore & Associates, Inc. | 2023-11-15 |
| HeartStart Onsite Defibrillator (M5066A), HeartStart Home Defibrillator (M5068A),HeartStart HS1 SMART Pads, Adult (M5071 (P160029/S021) | Philips Medical Systems, Inc. | 2023-11-15 |
| HeartLogic (P010012/S571) | Boston Scientific Corp | 2023-11-15 |
| EPIC Self Expanding Stent System (P110035/S071) | Boston Scientific Corp | 2023-11-15 |
| Innova Vascular Self-Expanding Stent System (P140028/S078) | Boston Scientific Corporation | 2023-11-15 |
| BD Onclarity HPV (P160037/S016) | Becton, Dickinson and Company | 2023-11-15 |
| HeartLogic (P960040/S493) | Boston Scientific | 2023-11-15 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S058) | Boston Scientific Corp | 2023-11-15 |
| Cerene® Cryotherapy Device (P180032/S014) | Channel Medsystems, Inc. | 2023-11-14 |
| AMS 700 Inflatable Penile Prosthesis (with and without InhibiZone) (N970012/S197) | Boston Scientific Corp | 2023-11-14 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S055) | ETHICON, Inc. | 2023-11-14 |
| SURGICEL® Absorbable Hemostats (N12159/S106) | ETHICON, Inc. | 2023-11-14 |
| HV Splitter/Adaptor kit (P920015/S281) | Medtronic, Inc. | 2023-11-13 |
| samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr (P160008/S022) | Heartsine Technologies, Ltd. | 2023-11-13 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S014) | Edwards Lifesciences, LLC | 2023-11-13 |
| Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle) (P050050/S024) | Djo Global | 2023-11-13 |
| Alto Abdominal Stent Graft System (P120006/S043) | Endologix, LLC | 2023-11-09 |
| Restylane Injectable Gel (P040024/S140) | Q-Med AB | 2023-11-09 |
| remede System IPG (P160039/S009) | Respicardia | 2023-11-09 |
| Rotlex IOLA MFD (P200020/S004) | Lenstec, Inc. | 2023-11-09 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S062) | Boston Scientific Corp | 2023-11-09 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S418) | Medtronic, Inc. | 2023-11-09 |
| Restylane Refyne, Restylane Defyne and Restylane Kysse (P140029/S050) | Q-Med AB | 2023-11-09 |
| PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S052) | Ventana Medical Systems, Inc. | 2023-11-08 |
| VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S009) | Ventana Medical Systems, Inc. | 2023-11-08 |
| VENTANA PD-Ll (SP142) Assay (P160002/S022) | Ventana Medical Systems, Inc. | 2023-11-08 |
| INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S040) | Ventana Medical Systems, Inc. | 2023-11-08 |
| VENTANA PD-Ll (SP263) Assay (P160046/S017) | Ventana Medical Systems, Inc. | 2023-11-08 |
| LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S014) | DiaSorin, Inc. | 2023-11-08 |
| VENTANA ALK (D5F3) CDx Assay (P140025/S022) | Ventana Medical Systems, Inc. | 2023-11-08 |
| 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/S763) | Medtronic, Inc. | 2023-11-08 |
| Alinity i Free PSA Reagent Kit (P980007/S053) | Abbott Laboratories | 2023-11-08 |
| LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control Anti-HBc (P180038/S016) | DiaSorin, Inc. | 2023-11-08 |
| VENTANA MMR RxDx Panel, VENTANA ANTI-MLH1 (M1), VENTANA ANTI-MSH6 (SP93), VENTANA ANTI-MSH2 (G219-1129), VENTANA ANTI-PM (P210001/S010) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2023-11-08 |
| Alinity i Total PSA Reagent Kit (P910007/S064) | Abbott Laboratories | 2023-11-08 |
| prodisc® L (P050010/S024) | Centinel Spine, LLC | 2023-11-08 |
| LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test (P190017/S017) | DiaSorin, Inc. | 2023-11-08 |
| Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S181) | Medtronic, Inc. | 2023-11-08 |
| LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers (P180039/S015) | DiaSorin, Inc. | 2023-11-08 |
| PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S030) | Ventana Medical Systems, Inc. | 2023-11-08 |
| VENTANA MMR RxDx Panel, VENTANA ANTI-MLH1 (M1), VENTANA ANTI-MSH6 (SP93), VENTANA ANTI-MSH2 (G219-1129), VENTANA ANTI-PM (P200019/S008) | Ventana Medical Systems | 2023-11-08 |
| LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S013) | DiaSorin, Inc. | 2023-11-08 |
| Alinity i AFP Reagent Kit (P120008/S026) | Abbott Laboratories | 2023-11-08 |
| On-X Prosthetic Heart Valve and Ascending Aortic Prothesis (P000037/S061) | On-X Life Technologies, Inc. | 2023-11-08 |
| CINtec PLUS Cytology (P190024/S011) | Ventana Medical Systems, Inc. | 2023-11-08 |
| VENTANA FOLR1 (FOLR1-2.1) RxDx Assay (P220006/S004) | Ventana Medical Systems, Inc. | 2023-11-08 |
| LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S014) | DiaSorin, Inc. | 2023-11-08 |
| prodisc® C (P070001/S024) | Centinel Spine, LLC | 2023-11-08 |
| LIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S024) | DiaSorin, Inc. | 2023-11-08 |
| Lava Liquid Embolic System (Lava LES) (P220020/S002) | Sirtex Medical, Inc. | 2023-11-07 |
| Open Pivot heart valve (P990046/S069) | Medtronic Ats Medical, Inc. | 2023-11-07 |
| PD-L1 IHC 22C3 pharmDx (P150013/S027) | Agilent Technologies, Inc. | 2023-11-07 |
| Paradise® Ultrasound Renal Denervation System (P220023) | Recor Medical, Inc. | 2023-11-07 |
| PorticoTM, NavitorTM, and Navitor Titan Transcatheter Aortic Heart Valves (P190023/S016) | ABBOTT MEDICAL | 2023-11-07 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo Pro Delivery Catheter System, Evolut PRO+ Delivery Catheter (P130021/S150) | Medtronic, Inc. | 2023-11-07 |
| WaveWriter Alpha Spinal Cord Stimulator (SCS) System (P030017/S365) | Boston Scientific Corp | 2023-11-06 |
| Alinity i Anti-HBc IgM Reagent Kit (2xl00 Tests) (P060035/S041) | Abbott Laboratories | 2023-11-06 |
| Alinity i Anti-HBs Reagent Kit (2x 100 Tests), Alinity i Anti-HBs Reagent Kit (2x600 Tests), Alinity i Anti-HBs Reagent (P050051/S056) | Abbott Laboratories, Inc. | 2023-11-06 |
| Alinity i HBsAg Qualitative II Reagent Kit (2x l 00 Tests), Alinity i HBsAg Qualitative II Reagent Kit (2x600 Tests), Al (P110029/S047) | Abbott Laboratories | 2023-11-06 |
| Hintermann Series H3 Total Ankle Replacement System (P160036/S004) | Dt Medtech, LLC | 2023-11-06 |
| Alinity i Anti-HBc Reagent Kit (2x 100 Tests), Alinity i Anti-HBc Reagent Kit (2x600 Tests) (P080023/S043) | Abbott Laboratories | 2023-11-06 |
| HearCare MED-EL, MAESTRO System Software 10.0 (P000025/S126) | Med-El Corp. | 2023-11-05 |
| Alinity i Anti-HBc Reagent Kit (2x100 Tests), Alinity i Anti-HBc Reagent Kit (2x600 Tests) (P080023/S042) | Abbott Laboratories | 2023-11-03 |
| Alinity i Anti-HBs Reagent Kit (2x100 Tests), Alinity i Anti-HBs Reagent Kit (2x600 Tests), Alinity i Anti-HBs Reagent K (P050051/S055) | Abbott Laboratories, Inc. | 2023-11-03 |