| ENROUTE Transcarotid Stent System (P140026/S027) | Boston Scientific Corporation | 2023-07-20 |
| Astron Pulsar, Pulsar-18, Pulsar-18 T3 (P160025/S017) | Biotronik AG | 2023-07-20 |
| S-ICD GEN 2 A209, S-ICD EMBLEM MRI A219 (P110042/S187) | Boston Scientific Corporation | 2023-07-20 |
| LeukoStrat CDx FLT3 Mutation Assay (P160040/S011) | Invivoscribe Technologies, Inc. | 2023-07-20 |
| ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM EL ICD DR, VIGILANT EL ICD VR (P960040/S495) | Boston Scientific | 2023-07-20 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S045) | Medinol, Ltd. | 2023-07-20 |
| Prospera SCS System (P210037/S001) | Biotronik Nro, Inc. | 2023-07-20 |
| FoundationOne CDx (F1CDx) (P170019/S040) | Foundation Medicine, Inc. | 2023-07-20 |
| Astron (P140030/S016) | Biotronik AG | 2023-07-20 |
| Xience Skypoint Everolimus Eluting Coronary Stent System (P110019/S125) | Abbott Vascular | 2023-07-20 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S454) | Medtronic, Inc. | 2023-07-20 |
| QDOT MICRO CATHETER, nGEN RF Generator, TX eco Cable, TX eco EXT Cable (P210027/S002) | Biosense Webster, Inc. | 2023-07-20 |
| MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CRT-D, RESONATE CRT- (P010012/S574) | Boston Scientific Corp | 2023-07-20 |
| DiamondTemp Ablation System (P200028/S021) | Medtronic, Inc. | 2023-07-19 |
| Neutrino NxT HF, Avant HF, Gallant HF, Entrant HF (P030054/S409) | ABBOTT MEDICAL | 2023-07-19 |
| CardioMEMSTM HF System (P100045/S067) | ABBOTT MEDICAL | 2023-07-19 |
| Medtronic Open Pivot Aortic Valved Graft (AVG) (P990046/S066) | Medtronic Ats Medical, Inc. | 2023-07-19 |
| LIAISON QuantiFERON-TB Gold Plus (P180047/S019) | DiaSorin, Inc. | 2023-07-18 |
| GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S100) | W. L. Gore & Associates, Inc. | 2023-07-18 |
| THERMOCOOL SMARTTOUCH® Catheter (P030031/S126) | Biosense Webster, Inc. | 2023-07-18 |
| Exablate Model 4000 Type 1.0 and 1.1 Systems (Exablate Neuro) (P150038/S015) | Insightec | 2023-07-18 |
| GORE® VIABAHN® Endoprosthesis (P040037/S161) | W. L. Gore & Associates, Inc. | 2023-07-18 |
| Alinity m HBV (P200013/S015) | Abbott Molecular, Inc. | 2023-07-18 |
| 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/S862) | Medtronic Cardiac Rhythm Disease Management | 2023-07-17 |
| 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/S828) | Medtronic Cardiac Rhythm Disease Management | 2023-07-17 |
| ROTAPRO Rotational Atherectomy System (P900056/S208) | Boston Scientific Corp | 2023-07-17 |
| VESTA/GUARDIO Charger (P180036/S018) | Impulse Dynamics (Usa), Inc. | 2023-07-17 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S523) | Medtronic, Inc. | 2023-07-17 |
| IntellaNav MiFi Open-Irrigated (OI) Ablation Catheter (P150005/S076) | Boston Scientific Corp | 2023-07-17 |
| PERFLUORON (P950018/S023) | Alcon Laboratories | 2023-07-17 |
| Cerene Cryotherapy Device (P180032/S013) | Channel Medsystems, Inc. | 2023-07-17 |
| 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/S753) | Medtronic, Inc. | 2023-07-17 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S175) | Medtronic, Inc. | 2023-07-17 |
| Nucleus CI522 Cochlear Implant, Nucleus CI532 Cochlear Implant, Nucleus CI622 Cochlear Implant, Nucleus CI624 Cochlear I (P970051/S219) | Cochlear Americas | 2023-07-14 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S408) | Medtronic, Inc. | 2023-07-14 |
| XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S (P110019/S127) | Abbott Vascular | 2023-07-14 |
| iStent inject® W Trabecular Micro-Bypass System (P170043/S017) | Glaukos Corporation | 2023-07-14 |
| 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/S754) | Medtronic, Inc. | 2023-07-13 |
| Mynx Control Vascular Control Device (5F, 6F/7F) (P040044/S094) | Cordis US Corporation | 2023-07-13 |
| iStent inject® W Trabecular Micro-Bypass System (P170043/S016) | Glaukos Corporation | 2023-07-13 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S040) | W. L. Gore & Associates, Inc. | 2023-07-13 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S522) | Medtronic, Inc. | 2023-07-13 |
| KONECT RESILIA Aortic Valved Conduit (P150048/S072) | Edwards Lifesciences, LLC | 2023-07-12 |
| Bulkamid Urethral Bulking System (P170023/S015) | Boston Scientific Corporation | 2023-07-12 |
| Radiesse Injectable Implant, Radiesse Hands, Radiesse (+) Lidocaine, Radiesse (+) Jawline (P050052/S150) | Merz North America, Inc. | 2023-07-12 |
| Natrelle Silicone-Filled Breast Implants (P020056/S061) | Allergan | 2023-07-12 |
| Radiesse® Injectable Implant (P050037/S128) | Merz North America, Inc. | 2023-07-12 |
| iCast Covered Stent System (P120003/S001) | Atrium Medical Corp. | 2023-07-12 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S217) | Medtronic Cardiac Rhythm Disease Management | 2023-07-11 |
| SURGICEL® ORIGINAL Absorbable Hemostat, SURGICEL® NU-KNIT Absorbable Hemostat, SURGICEL® SNOW Absorbable Hemostat (N12159/S104) | ETHICON, Inc. | 2023-07-11 |
| Sprint Quattro Lead (P920015/S279) | Medtronic, Inc. | 2023-07-11 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S253) | Medtronic, Inc. | 2023-07-11 |
| CapSureFix MRI Lead (P090013/S328) | Medtronic, Inc. | 2023-07-11 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead, (P080006/S177) | Medtronic, Inc. | 2023-07-11 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S034) | Smith & Nephew, Inc. | 2023-07-11 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S463) | Medtronic, Inc. | 2023-07-11 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S176) | Medtronic, Inc. | 2023-07-11 |
| Deflux Injectable Gel (P000029/S096) | Palette Life Sciences | 2023-07-11 |
| CapSure Epicardial Pacing Lead (P950024/S107) | Medtronic, Inc. | 2023-07-11 |
| Solesta Injectable Gel (P100014/S034) | Palette Life Sciences | 2023-07-11 |
| Sculptra and Sculptra Aesthetic (P030050/S042) | Q-Med AB | 2023-07-11 |
| ARCHITECT AFP / Alinity i AFP (P120008/S024) | Abbott Laboratories | 2023-07-10 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S051) | Abbott Laboratories | 2023-07-10 |
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S041) | Abbott Laboratories | 2023-07-10 |
| ARCHITECT HBsAg Qualitative/ Qualitative Confirmatory / Alinity i HBsAg Qualitative II/ Qualitative II Confirmatory (P110029/S045) | Abbott Laboratories | 2023-07-10 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S039) | Abbott Laboratories | 2023-07-10 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory (P210003/S008) | Abbott Laboratories | 2023-07-10 |
| ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S054) | Abbott Laboratories, Inc. | 2023-07-10 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S062) | Abbott Laboratories | 2023-07-10 |
| Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System (P150031/S056) | Boston Scientific Corp | 2023-07-10 |
| Implantable Cardioverter Defibrillators (ICDs) (P960040/S494) | Boston Scientific | 2023-07-07 |
| HeartWare® Ventricular Assist System (P100047/S212) | Medtronic | 2023-07-07 |
| Myopore® Sutureless Myocardial Pacing Lead (P130012/S014) | Great Batch Medical | 2023-07-07 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S186) | Boston Scientific Corporation | 2023-07-07 |
| Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) (P010012/S573) | Boston Scientific Corp | 2023-07-07 |
| Aptima HPV Assay (P100042/S035) | Gen-Probe Incorporated | 2023-07-07 |
| AngioSculpt RX PTCA Scoring Balloon Catheter, AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S032) | Spectranetics Corp. | 2023-07-07 |
| Edwards SAPIEN 3 Transcatheter Heart Valves, Edwards SAPIEN 3 Ultra Transcatheter Heart Valves, Edwards SAPIEN 3 Ultra R (P140031/S159) | Edwards Lifesciences, LLC | 2023-07-06 |
| Guardian 4 Sensor (P160017/S111) | Medtronic Minimed, Inc. | 2023-07-06 |
| FINELINE® II Sterox, FINELINE® II EZ Sterox (P960004/S103) | Boston Scientific | 2023-07-06 |
| EMBLEM S-ICD, (P110042/S185) | Boston Scientific Corporation | 2023-07-06 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S064) | Syncardia Systems, LLC | 2023-07-06 |
| ACUITY Spiral, ACUITY X4 Straight, ACUITY X4 Spiral (P010012/S572) | Boston Scientific Corp | 2023-07-06 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S007) | Edwards Lifesciences, LLC | 2023-07-06 |
| ENDOTAK RELIANCE®, RELIANCE 4-FRONT (P910073/S172) | Boston Scientific | 2023-07-06 |
| Skinvive by Juvéderm® (P110033/S076) | Allergan | 2023-07-06 |
| INGEVITY MRI, INGEVITY+ (P150012/S147) | Boston Scientific | 2023-07-06 |
| Edwards SAPIEN 3 Transcatheter Heart Valves (P200015/S042) | Edwards Lifesciences, LLC | 2023-07-06 |
| CraniSeal Dural Sealant (P220014) | Pramand, LLC | 2023-07-06 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S041) | W. L. Gore & Associates, Inc. | 2023-07-05 |
| GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S160) | W. L. Gore & Associates, Inc. | 2023-07-05 |
| RHA® Redensity, RHA®2, RHA®3 and RHA® Dermal Fillers (P170002/S023) | Teoxane S.A. | 2023-07-05 |
| 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/S852) | Medtronic Cardiac Rhythm Disease Management | 2023-07-05 |
| GORE® TAG® Thoracic Branch Endoprosthesis (Side Branch Component only) (P210032/S010) | W. L. Gore & Associates, Inc. | 2023-07-05 |
| PD-L1 IHC 22C3 pharmDx (P150013/S026) | Agilent Technologies, Inc. | 2023-07-05 |
| GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S099) | W. L. Gore & Associates, Inc. | 2023-07-05 |
| 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/S818) | Medtronic Cardiac Rhythm Disease Management | 2023-07-05 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR (P980035/S752) | Medtronic, Inc. | 2023-07-03 |
| HeartMate 3 Left Ventricular Assist System (P160054/S051) | ABBOTT MEDICAL | 2023-07-03 |
| LIFEPAK® 1000 Defibrillator (P160026/S039) | Physio-Control, Inc. | 2023-07-03 |