| Titan Inflatable Penile Prosthesis (IPP) (P000006/S063) | Coloplast Corp. | 2022-12-01 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf (P100021/S111) | Medtronic Vascular | 2022-12-01 |
| Resolute Onyx Rapid Exchange Zotarolimus- Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus- Elutin (P160043/S064) | Medtronic Vascular | 2022-12-01 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated (P140010/S071) | Medtronic, Inc. | 2022-12-01 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extens (P100040/S055) | Medtronic Vascular | 2022-12-01 |
| Harmony Delivery Catheter System (P200046/S013) | Medtronic, Inc. | 2022-12-01 |
| Medtronic CoreValve Evolut FX System (P130021/S129) | Medtronic, Inc. | 2022-12-01 |
| NovaSure Impedance Controlled Endometrial Ablation System (P010013/S089) | Hologic, Inc. | 2022-12-01 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S022) | Medtronic Vascular, Inc. | 2022-12-01 |
| Abbott RealTime IDH1, Abbott RealTime IDH1 Amplification Reagent Kit, Abbott RealTime IDH1 Control Kit, Abbott RealTime (P170041/S006) | Abbott Molecular, Inc. | 2022-12-01 |
| VenaSeal Closure System (P140018/S036) | Medtronic Vascular, Inc. | 2022-12-01 |
| Light Adjustable Lens, Light Delivery Device (P160055/S026) | Rxsight, Inc. | 2022-11-30 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Eudurant IIs Stent Graft System, Endurant II Aorto-Uni-Ilia (P100021/S109) | Medtronic Vascular | 2022-11-30 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler (P050052/S140) | Merz North America, Inc. | 2022-11-30 |
| RADIESSE® Injectable Implant (P050037/S119) | Merz North America, Inc. | 2022-11-30 |
| PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer (P170022/S001) | Arj Medical, Inc. | 2022-11-30 |
| COAPTITE Injectable Impant (P040047/S067) | Merz North America, Inc. | 2022-11-30 |
| eCoin Implant Tibial Stimulator (P200036/S004) | Boston Scientific Corporation | 2022-11-30 |
| COAPTITE® Injectable Implant (P040047/S066) | Merz North America, Inc. | 2022-11-29 |
| cobas® EGFR Mutation Test (P120019/S033) | Roche | 2022-11-29 |
| cobas® EZH2 Mutation Test (P200014/S004) | Roche Molecular System, Inc. | 2022-11-29 |
| cobas® KRAS Mutation Test (P140023/S024) | Roche Molecular Systems, Inc. | 2022-11-29 |
| Trifecta Valve with Glide Technology (P100029/S047) | ABBOTT MEDICAL | 2022-11-29 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline (P050052/S139) | Merz North America, Inc. | 2022-11-29 |
| RADIESSE® Injectable Implant (P050037/S118) | Merz North America, Inc. | 2022-11-29 |
| cobas® BRAF V600 Mutation Test (P110020/S036) | Roche Molecular Systems, Inc. | 2022-11-29 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S062) | Boston Scientific Scimed, Inc. | 2022-11-28 |
| SelectSecure Lead (P030036/S141) | Medtronic Cardiac Rhythm Disease Management | 2022-11-28 |
| Micra AV TPS, Micra TPS (P150033/S163) | Medtronic, Inc. | 2022-11-28 |
| LDR Spine Mobi-C® Cervical Disc Prosthesis (P110009/S034) | Highridge Medical, LLC | 2022-11-28 |
| Medtronic Melody Transcatheter Pulmonic Valve System (P140017/S023) | Medtronic, Inc. | 2022-11-28 |
| Endurant Stent Graft System, Endurant II Stent Graft System and Endurant II AUI Stent Graft System (P100021/S110) | Medtronic Vascular | 2022-11-28 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S130) | Boston Scientific Corp | 2022-11-28 |
| LDR Spine Mobi-C® Cervical Disc Prosthesis (P110002/S034) | Highridge Medical, LLC | 2022-11-28 |
| WALLSTENT Venous Endoprosthesis with Unistep Plus Delivery System (P980033/S061) | Boston Scientific Corporation | 2022-11-28 |
| Resolute Onyx Rapid Exchange Zotarolimus-Eluting Coronary Stent System, Resoulute Onyx Over The Wire Zotarolimus-Eluting (P160043/S063) | Medtronic Vascular | 2022-11-28 |
| WALLSTENT TIPS Endoprosthesis with Unistep Plus Delivery System (P930031/S071) | Boston Scientific Corp | 2022-11-28 |
| Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extension) with the Captivia Delivery System and Valiant Thoracic Sten (P100040/S054) | Medtronic Vascular | 2022-11-28 |
| Medtronic CoreValve0153 Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System and Med (P130021/S127) | Medtronic, Inc. | 2022-11-28 |
| Express® LD Iliac Premounted Stent System (P090003/S053) | Boston Scientific Corporation | 2022-11-28 |
| Alinity m CMV (P210022/S002) | Abbott Molecular, Inc. | 2022-11-28 |
| Carotid WALLSTENT Monorail Endoprosthesis System (P050019/S036) | Boston Scientific Corp | 2022-11-28 |
| Promus Everolimus-Eluting Platinum Chromium Coronary Stent Systems (P110010/S206) | Boston Scientific Corp | 2022-11-28 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent Systems (P150003/S089) | Boston Scientific Corporation | 2022-11-28 |
| Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System and Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator (P850022/S031) | Ahp Eos Buyer, Inc. | 2022-11-23 |
| SpF® Implantable Spinal Fusion Stimulators (P850035/S058) | Ahp Eos Buyer, Inc. | 2022-11-23 |
| QDOT MICRO System (P210027) | Biosense Webster, Inc. | 2022-11-23 |
| HeartSine samaritan® Public Access Automated External Defibrillators and Accessories (P160008/S020) | Heartsine Technologies, Ltd. | 2022-11-23 |
| Biomet® OrthoPak Non-invasive Bone Growth Stimulator System (P790002/S038) | Ahp Eos Buyer, Inc. | 2022-11-23 |
| HeartSines samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories (P160008/S021) | Heartsine Technologies, Ltd. | 2022-11-23 |
| Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter (P190019/S017) | Boston Scientific Corporation | 2022-11-23 |
| EBI OsteoGen® Implantable Bone Growth Stimulators (P790005/S069) | Ahp Eos Buyer, Inc. | 2022-11-23 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S061) | Boston Scientific Scimed, Inc. | 2022-11-22 |
| CapSure Epicardial Pacing Lead (P950024/S105) | Medtronic, Inc. | 2022-11-22 |
| SelectSecure Lead (P030036/S140) | Medtronic Cardiac Rhythm Disease Management | 2022-11-22 |
| Attain Ability Lead, Attain Performa Lead and Attain Stability Quad MRI Lead (P080006/S173) | Medtronic, Inc. | 2022-11-22 |
| HV Splitter/Adaptor Kit, Sprint Quattro Lead (P920015/S273) | Medtronic, Inc. | 2022-11-22 |
| 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/S734) | Medtronic, Inc. | 2022-11-22 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT VR ICD, (P980016/S841) | Medtronic Cardiac Rhythm Disease Management | 2022-11-22 |
| 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/S808) | Medtronic Cardiac Rhythm Disease Management | 2022-11-22 |
| Floseal Hemostatic Matrix, RT5 and RTl 0, Floseal Hemostatic Matrix, Fast Prep (P990009/S071) | Baxter Healthcare Corp | 2022-11-22 |
| CapSure SP Novus Lead, CapSure SP Z Lead and Vitatron Impulse II Lead (P850089/S163) | Medtronic Cardiac Rhythm Disease Management | 2022-11-22 |
| 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/S735) | Medtronic, Inc. | 2022-11-22 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S376) | Medtronic Neuromodulation | 2022-11-22 |
| Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® (P840001/S532) | Medtronic Neuromodulation | 2022-11-22 |
| CapSure VDD-2 Lead and Vitatron Brilliant S+ VDD Lead (P890003/S458) | Medtronic, Inc. | 2022-11-22 |
| CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S247) | Medtronic, Inc. | 2022-11-22 |
| Supera Peripheral Stent System (P120020/S028) | Abbott Vascular (Idef Technologies Inc) | 2022-11-22 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S272) | Medtronic Neuromodulation | 2022-11-22 |
| CapSure Sense Lead and Vitatron Crysatlline Lead (P830061/S210) | Medtronic Cardiac Rhythm Disease Management | 2022-11-22 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S442) | Medtronic, Inc. | 2022-11-22 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S377) | Medtronic Neuromodulation | 2022-11-22 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S080) | Syncardia Systems, LLC | 2022-11-22 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S511) | Medtronic, Inc. | 2022-11-22 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S271) | Medtronic Neuromodulation | 2022-11-22 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S443) | Medtronic, Inc. | 2022-11-22 |
| Attain StarFix Lead (P060039/S112) | Medtronic, Inc. | 2022-11-22 |
| CapSureFix MRI Lead (P090013/S325) | Medtronic, Inc. | 2022-11-22 |
| Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® (P840001/S533) | Medtronic Neuromodulation | 2022-11-22 |
| Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System (P930031/S070) | Boston Scientific Corp | 2022-11-22 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S352) | Boston Scientific Corp | 2022-11-22 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena (P010015/S510) | Medtronic, Inc. | 2022-11-22 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S051) | Boston Scientific Corp | 2022-11-22 |
| Transvene CS/SVC Lead (P980050/S139) | Medtronic, Inc. | 2022-11-22 |
| STAR PSI System (P050050/S023) | Djo Global | 2022-11-22 |
| Perceval Sutureless Heart Valve (P150011/S026) | Corcym S.r.l. | 2022-11-21 |
| Open-Irrigated Cardiac Ablation Catheters (P150005/S072) | Boston Scientific Corp | 2022-11-21 |
| Biofinity, Biofinity Toric, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses (P080011/S150) | CooperVision, Inc. | 2022-11-21 |
| MitraClip G4 Clip Delivery System, MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System (P100009/S049) | ABBOTT MEDICAL | 2022-11-20 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S002) | Edwards Lifesciences, LLC | 2022-11-20 |
| BD Onclarity HPV Assay (P160037/S011) | Becton, Dickinson and Company | 2022-11-19 |
| MISAGO® RX Self-expanding Peripheral Stent (P140002/S023) | Terumo Medical Corporation | 2022-11-18 |
| R3 DELTA CERAMIC ACETABULAR SYSTEM (P150030/S028) | Smith & Nephew, Inc. | 2022-11-18 |
| Adapta, Versa, Sensia IPG, Relia IPG (P980035/S733) | Medtronic, Inc. | 2022-11-18 |
| GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis (P020004/S193) | W. L. Gore & Associates, Inc. | 2022-11-18 |
| SBL-3 Multifocal Intraocular Lens (P200020/S002) | Lenstec, Inc. | 2022-11-17 |
| SENSAR® 1-Piece IOL, Model AAB00, TECNIS® Monofocal 1-Piece IOL, Model ZCB00, TECNIS® Multifocal 1-Piece IOL, Model ZMB0 (P980040/S152) | Johnson & Johnson Surgical Vision, Inc. | 2022-11-17 |
| WOLVERINE Coronary Cutting Balloon (P950020/S131) | Boston Scientific Corp | 2022-11-17 |
| DIAMOND AF (P200028/S014) | Medtronic, Inc. | 2022-11-16 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System and Accessories (P200015/S031) | Edwards Lifesciences, LLC | 2022-11-16 |