| Enlite Sensor (MMT-7008) (P120010/S141) | Medtronic, Inc. | 2022-04-29 |
| Nucleus® 24 Cochlear Implant System (P970051/S208) | Cochlear Americas | 2022-04-29 |
| Silicone Stimulation Lead, Silicone Sensing Lead (P130008/S074) | Inspire Medical Systems | 2022-04-29 |
| Guardian Sensor (3) (MMT-7020), Enlite Sensor (MMT-7008) (P150001/S098) | Medtronic Minimed | 2022-04-29 |
| Guardian Sensor (3) (MMT-7020) (P160017/S100) | Medtronic Minimed, Inc. | 2022-04-29 |
| Enlite Sensor (MMT-7008) (P150029/S038) | Medtronic Minimed | 2022-04-29 |
| ENROUTE Transcarotid Stent System (P140026/S016) | Boston Scientific Corporation | 2022-04-28 |
| CollaCote, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S084) | Integra Lifesciences Corp. | 2022-04-28 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Fo (P810006/S098) | Integra LifeSciences Corporation | 2022-04-28 |
| FreeStyle Libre 14 day Flash Glucose Monitoring System (P160030/S051) | Abbott Diabetes Care, Inc. | 2022-04-28 |
| Medtronic MiniMed 630G System (P150001/S097) | Medtronic Minimed | 2022-04-28 |
| Medtronic MiniMed 630G insulin pump (P150001/S096) | Medtronic Minimed | 2022-04-28 |
| Juvéderm Ultra, Ultra XC and Ultra Plus XC, Juvéderm Ultra XC (P050047/S085) | Allergan | 2022-04-28 |
| Patient Connector (P890003/S453) | Medtronic, Inc. | 2022-04-28 |
| Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form (P850010/S101) | Integra LifeSciences Corporation | 2022-04-28 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S057) | Abbott Diabetes Care, Inc. | 2022-04-28 |
| Medtronic MiniMed 670G System (P160017/S099) | Medtronic Minimed, Inc. | 2022-04-28 |
| Medtronic MiniMed 670G insulin pump, Medtronic MiniMed 770G insulin pump (P160017/S098) | Medtronic Minimed, Inc. | 2022-04-28 |
| Rotablator Rotational Angioplasty System, ROTAPRO Rotational Artherectomy System, ROTAWIRE Drive (P900056/S199) | Boston Scientific Corp | 2022-04-28 |
| Prometra Programmable Infusion Pump System (P080012/S072) | Infusyn Therapeutics, LLC | 2022-04-28 |
| Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC (P110033/S066) | Allergan | 2022-04-28 |
| Cordis PRECISE Nitinol Stent System (P030047/S044) | Cordis US Corporation | 2022-04-27 |
| TactiSys Quartz Equipment (P130026/S078) | St Jude Medical | 2022-04-27 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S124) | Vistakon, Division of Johnson & Johnson Vision Car | 2022-04-27 |
| Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Cont (P080011/S143) | CooperVision, Inc. | 2022-04-27 |
| OCS Heart System (P180051/S001) | TransMedics, Inc. | 2022-04-27 |
| LCS Total Knee System (P830055/S288) | Depuy, Inc. | 2022-04-27 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S360) | Medtronic Neuromodulation | 2022-04-26 |
| Micra AV TPS, Micra TPS (P150033/S137) | Medtronic, Inc. | 2022-04-26 |
| Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesi (P150048/S064) | Edwards Lifesciences, LLC | 2022-04-26 |
| Epic Plus Tissue Heart Valves (P040021/S050) | ABBOTT MEDICAL | 2022-04-26 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S496) | Medtronic, Inc. | 2022-04-26 |
| FRED X System (P180027/S005) | MicroVention, Inc. | 2022-04-26 |
| Barostim System (P180050/S005) | Cvrx, Inc. | 2022-04-26 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S255) | Medtronic Neuromodulation | 2022-04-26 |
| 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/S814) | Medtronic Cardiac Rhythm Disease Management | 2022-04-26 |
| 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/S713) | Medtronic, Inc. | 2022-04-26 |
| 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/S781) | Medtronic Cardiac Rhythm Disease Management | 2022-04-26 |
| MYNX Vascular Closure Device (P040044/S091) | Cordis US Corporation | 2022-04-25 |
| Venovo Venous Stent System (P180037/S009) | Bard Peripheral Vascular, Inc. | 2022-04-22 |
| HEMOBLAST Bellows (P170012/S028) | Dilon Technologies, Inc. | 2022-04-22 |
| 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/S812) | Medtronic Cardiac Rhythm Disease Management | 2022-04-21 |
| 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/S712) | Medtronic, Inc. | 2022-04-21 |
| CapSure Epicardial Pacing Lead (P950024/S103) | Medtronic, Inc. | 2022-04-21 |
| Micra AV TPS, Micra TPS (P150033/S136) | Medtronic, Inc. | 2022-04-21 |
| Attain StarFix Lead (P060039/S110) | Medtronic, Inc. | 2022-04-21 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead Ad (P920015/S267) | Medtronic, Inc. | 2022-04-21 |
| CapSure VDD-2 Lead, Service Kit-Pacemaker Repair Kit, Vitatron Brilliant S+ VDD Lead (P890003/S452) | Medtronic, Inc. | 2022-04-21 |
| Anchoring Sleeve Kit, SelectSecure Lead (P030036/S137) | Medtronic Cardiac Rhythm Disease Management | 2022-04-21 |
| Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S206) | Medtronic Cardiac Rhythm Disease Management | 2022-04-21 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S161) | Medtronic Cardiac Rhythm Disease Management | 2022-04-21 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena (P010015/S495) | Medtronic, Inc. | 2022-04-21 |
| End Cap, Epicardial Patch Lead, Upsizing Sleeve (P900061/S168) | Medtronic Cardiac Rhythm Disease Management | 2022-04-21 |
| Transvene CS/SVC Lead (P980050/S137) | Medtronic, Inc. | 2022-04-21 |
| CapSureFix MRI Lead (P090013/S320) | Medtronic, Inc. | 2022-04-21 |
| 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/S780) | Medtronic Cardiac Rhythm Disease Management | 2022-04-21 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S241) | Medtronic, Inc. | 2022-04-21 |
| Myocardial Pacing Lead (P120017/S030) | Medtronic, Inc. | 2022-04-21 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S170) | Medtronic, Inc. | 2022-04-21 |
| Axonics Sacral Neuromodulation System (P180046/S052) | Boston Scientific Corporation | 2022-04-20 |
| Saluda Medical Evoke® SCS System (P190002/S004) | Saluda Medical Pty, Ltd. | 2022-04-20 |
| Edwards INTUITY ELITE Delivery System (P150036/S062) | Edwards Lifesciences, LLC | 2022-04-20 |
| Soflens 38 (polymacon) Visibility Tinted Contact Lenses (N16895/S104) | Bausch & Lomb, Inc. | 2022-04-20 |
| Helistat and Helitene Absoibable Collagen Hemostatic Agents (P850010/S100) | Integra LifeSciences Corporation | 2022-04-20 |
| CT LUCIA Intraocular Lens (IOL) (P100016/S013) | Carl Zeiss Meditec Production, LLC | 2022-04-20 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System RX and OTW (P160043/S059) | Medtronic Vascular | 2022-04-20 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S039) | Medinol, Ltd. | 2022-04-20 |
| Revanesse Versa+ with Lidocaine (1.0 mL and 1.2 mL) and Revanesse Lips+ with Lidocaine (1.0 mL and 1.2 mL) (P160042/S017) | Prollenium Medical Technologies, Inc. | 2022-04-20 |
| Axonics Sacral Neuromodulation System (P190006/S052) | Boston Scientific Corporation | 2022-04-20 |
| AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone (N970012/S191) | Boston Scientific Corp | 2022-04-20 |
| Portico Transcatheter Aortic Heart Valve (P190023/S007) | ABBOTT MEDICAL | 2022-04-20 |
| AMS 800 Artificial Urinary Sphincter, AMS 800 Artificial Urinary Sphincter with InhibiZone (P000053/S125) | Boston Scientific Corp | 2022-04-20 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S041) | Medinol, Ltd. | 2022-04-19 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System RX and OTW (P110013/S116) | Medtronic Vascular | 2022-04-19 |
| Impella RP System, Impella RP with SmartAssist System (P170011/S035) | Abiomed, Inc. | 2022-04-19 |
| Integrity Rapid Exchange Coronary Stent System, Integrity Over The Wire Coronary Stent System (P030009/S107) | Medtronic, Ireland | 2022-04-19 |
| Impella 2.5 System, Impella CP System, Impella CP with SmartAssist System, Impella 5.0 System, Impella LD System,Impella (P140003/S088) | Abiomed, Inc. | 2022-04-19 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Navion Thoracic Stent Graft System (P100040/S051) | Medtronic Vascular | 2022-04-19 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo PRO Delivery Catheter System, Evolut PRO+ Delivery Cath (P130021/S113) | Medtronic, Inc. | 2022-04-19 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf (P100021/S103) | Medtronic Vascular | 2022-04-19 |
| Thoraflex Hybrid (P210006) | Vascutek, Ltd. | 2022-04-19 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S061) | Coloplast Corp. | 2022-04-15 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S779) | Medtronic Cardiac Rhythm Disease Management | 2022-04-15 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S811) | Medtronic Cardiac Rhythm Disease Management | 2022-04-15 |
| InterStim Therapy System (SNS Bowel Neurostimulators Implantable InterStim) (P080025/S254) | Medtronic Neuromodulation | 2022-04-15 |
| InterStim Therapy System (SNS Urinary Neurostimulator Implantable InterStim) (P970004/S359) | Medtronic Neuromodulation | 2022-04-15 |
| Trifecta and Trifecta Valve with Glide Technology (Trifecta GT) valves (P100029/S046) | ABBOTT MEDICAL | 2022-04-14 |
| Epic, Epic Supra and Epic Plus Tissue Heart Valves, Biocor and Biocor Supra Tissue Heart Valves (P040021/S049) | ABBOTT MEDICAL | 2022-04-14 |
| BioFreedom Drug Coated Coronary Stent System (P190020) | Biosensors International USA, Inc. | 2022-04-14 |
| Barostim System (P180050/S002) | Cvrx, Inc. | 2022-04-14 |
| ARCHITECT AUSAB, Alinity i Anti-HBs (P050051/S043) | Abbott Laboratories, Inc. | 2022-04-14 |
| Biofinity Sphere and Biofinity XR Sphere, Biofinity Toric and Biofinity XR Toric, Biofinity Energys, Biofinity Multifoca (P080011/S140) | CooperVision, Inc. | 2022-04-14 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S005) | Cook Medical Incorporated | 2022-04-14 |
| Zenith Dissection Endovascular System (P180001/S004) | William Cook Europe Aps | 2022-04-14 |
| CERAMAX Ceramic Total Hip System (P070026/S096) | DePuy Orthopaedics, Inc. | 2022-04-14 |
| EluNIR TM Ridaforolimus Eluting Coronary Stent System (P170008/S040) | Medinol, Ltd. | 2022-04-14 |
| FoundationOne CDx (FICDx) (P170019/S034) | Foundation Medicine, Inc. | 2022-04-13 |
| Rapid fFN for the TLiIQ System (P920048/S022) | Hologic, Inc. | 2022-04-13 |
| Tachy DF4 header core (P960040/S477) | Boston Scientific | 2022-04-13 |
| Tachy DF4 header core (P010012/S553) | Boston Scientific Corp | 2022-04-13 |