| AcrySof® Posterior Chamber Intraocular Lens (P930014/S139) | Alcon Laboratories, Inc. | 2021-08-23 |
| Impella 5.5 with SmartAssist (P140003/S087) | Abiomed, Inc. | 2021-08-23 |
| Scandinavian Total Ankle Replacement (S.T.A.R. Ankle) (P050050/S019) | Djo Global | 2021-08-23 |
| Freezor Xtra Cardiac Cryoablation Catheter (P020045/S099) | Medtronic Cryocath, LP | 2021-08-22 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S032) | Medinol, Ltd. | 2021-08-20 |
| Arista AH Absorbable Hemostatic Particles Device (P050038/S039) | Davol, Inc. | 2021-08-20 |
| Neuro Cochlear Implant System (P200021/S001) | Oticon Medical | 2021-08-20 |
| SelectSecure Lead (P030036/S132) | Medtronic Cardiac Rhythm Disease Management | 2021-08-20 |
| SenSight Directional Lead Kit, SenSight Extension Kit (P960009/S405) | Medtronic, Inc. | 2021-08-20 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S198) | Medtronic Cardiac Rhythm Disease Management | 2021-08-20 |
| CapSure SP Novus Lead, CapSure Z Novus Lead (P850089/S157) | Medtronic Cardiac Rhythm Disease Management | 2021-08-20 |
| CentriMag Circulatory Support System (P170038/S007) | Abbott | 2021-08-19 |
| Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR- (P980023/S107) | Biotronik, Inc. | 2021-08-19 |
| Masters Mechanical Heart Valve (P810002/S113) | ABBOTT MEDICAL | 2021-08-19 |
| Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T (P070008/S128) | Biotronik, Inc. | 2021-08-19 |
| Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T ( (P950037/S227) | Biotronik, Inc. | 2021-08-19 |
| LCS® Total Knee System (P830055/S271) | Depuy, Inc. | 2021-08-19 |
| CERAMAX® Total Hip System (P070026/S084) | DePuy Orthopaedics, Inc. | 2021-08-19 |
| TheraSphere (P200029/S002) | Boston Scientific Corporation | 2021-08-19 |
| Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T ( (P050023/S160) | Biotronik, Inc. | 2021-08-19 |
| Sprint Quattro Lead (P920015/S257) | Medtronic, Inc. | 2021-08-19 |
| Sprint Quattro Lead, Y Adaptor/Extender (P920015/S258) | Medtronic, Inc. | 2021-08-19 |
| Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T (P000009/S094) | Biotronik, Inc. | 2021-08-19 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S339) | Medtronic Neuromodulation | 2021-08-18 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S234) | Medtronic Neuromodulation | 2021-08-18 |
| CapSure Epicardial Pacing Lead (P950024/S099) | Medtronic, Inc. | 2021-08-17 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S156) | Medtronic Cardiac Rhythm Disease Management | 2021-08-17 |
| NexGen LPS-Flex / LPS-Mobile Bearing Knee (P060037/S074) | Zimmer, Inc. | 2021-08-17 |
| End Cap, Epicardial Patch Lead, Upsizing Sleeve (P900061/S165) | Medtronic Cardiac Rhythm Disease Management | 2021-08-17 |
| Myocardial Pacing Lead (P120017/S028) | Medtronic, Inc. | 2021-08-17 |
| CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S197) | Medtronic Cardiac Rhythm Disease Management | 2021-08-17 |
| IntellaTip MiFi Filter Module, IntellaTip MiFi Reference Cable, EGM Cable, Maestro 4000 Footswitch (P020025/S132) | Boston Scientific | 2021-08-17 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S162) | Medtronic, Inc. | 2021-08-17 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S447) | Medtronic, Inc. | 2021-08-17 |
| 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, (P980016/S789) | Medtronic Cardiac Rhythm Disease Management | 2021-08-17 |
| VENTANA MMR RxDx Panel (P210001) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2021-08-17 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead Ad (P920015/S259) | Medtronic, Inc. | 2021-08-17 |
| 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 M (P010031/S754) | Medtronic Cardiac Rhythm Disease Management | 2021-08-17 |
| Adapta, Versa, Sensia IPG (P980035/S689) | Medtronic, Inc. | 2021-08-17 |
| Transvene CS/SVC Lead (P980050/S134) | Medtronic, Inc. | 2021-08-17 |
| Attain StarFix Lead (P060039/S108) | Medtronic, Inc. | 2021-08-17 |
| Progel Pleural Air Leak Sealant (P010047/S063) | Neomend, Inc. | 2021-08-17 |
| Tridyne Vascular Sealant (P150016/S019) | Neomend, Inc. | 2021-08-17 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead (P010015/S481) | Medtronic, Inc. | 2021-08-17 |
| Anchoring Sleeve Kit, SelectSecure Lead (P030036/S131) | Medtronic Cardiac Rhythm Disease Management | 2021-08-17 |
| CapSureFix Lead (P930039/S229) | Medtronic, Inc. | 2021-08-17 |
| CareLink SmartSync Azure Astra Application (P980035/S684) | Medtronic, Inc. | 2021-08-16 |
| SURGICEL Absorbable Hemostats (N12159/S081) | ETHICON, Inc. | 2021-08-16 |
| PROMUS Premier and PROMUS Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S197) | Boston Scientific Corp | 2021-08-16 |
| CareLink SmartSync Percepta Serena Solara Application (P010015/S475) | Medtronic, Inc. | 2021-08-16 |
| CareLink SmartSync Cobalt, Crome Application (P010031/S747) | Medtronic Cardiac Rhythm Disease Management | 2021-08-16 |
| CareLink SmartSync Platform, CareLink SmartSync Common Application and CareLink SmartSync MRI Host Application (P890003/S445) | Medtronic, Inc. | 2021-08-16 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049) | ABBOTT MEDICAL | 2021-08-14 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S183) | W. L. Gore & Associates, Inc. | 2021-08-13 |
| GORE CARDIOFORM Septal Occluder (P050006/S094) | W. L. Gore & Associates, Inc. | 2021-08-13 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S145) | W. L. Gore & Associates, Inc. | 2021-08-13 |
| X Series, AED Pro, Propaq MD (P160022/S030) | ZOLL Medical Corporation | 2021-08-13 |
| AED 3, AED Plus (P160015/S012) | ZOLL Medical Corporation | 2021-08-13 |
| Smart Monitor, Smart Spot, SmartView Monitor, SmartView HotSpot (P060027/S105) | MicroPort CRM USA, Inc. | 2021-08-13 |
| SURGIFOAM Absorbable Gelatin Sponge, U.S.P. (P990004/S045) | Ferrosan Meidcal Devices A/S | 2021-08-13 |
| Smart Monitor, Smart Spot, SmartView Monitor, SmartView HotSpot (P950029/S129) | MicroPort CRM USA, Inc. | 2021-08-13 |
| RHA 2, RHA 3, RHA Dermal Fillers (P170002/S018) | Teoxane S.A. | 2021-08-13 |
| Zephyr Endobronchial Valve (Zephyr Valve) (P180002/S019) | Pulmonx Corporation | 2021-08-13 |
| Assurity MRI, Endurity MRI (P140033/S068) | ABBOTT MEDICAL | 2021-08-13 |
| Smart Monitor, Smart Spot, SmartView Monitor, SmartView HotSpot (P980049/S141) | MicroPort CRM USA, Inc. | 2021-08-13 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S496) | Medtronic Neuromodulation | 2021-08-13 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S084) | W. L. Gore & Associates, Inc. | 2021-08-13 |
| CardioMessenger Smart 4G (P050023/S159) | Biotronik, Inc. | 2021-08-13 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S404) | Medtronic, Inc. | 2021-08-13 |
| lnterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S337) | Medtronic Neuromodulation | 2021-08-13 |
| lnterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S232) | Medtronic Neuromodulation | 2021-08-13 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S051) | Medtronic Vascular | 2021-08-13 |
| Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG, Azure XT SR MRI I (P980035/S688) | Medtronic, Inc. | 2021-08-12 |
| ORBERA Intragastric Balloon (IGB) System (P140008/S022) | Boston Scientific Corporation | 2021-08-12 |
| Inspire Implantable Pulse Generator (IPG) (P130008/S071) | Inspire Medical Systems | 2021-08-12 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S097) | Integra LifeSciences Corporation | 2021-08-12 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera XT DR ICD, Ev (P980016/S788) | Medtronic Cardiac Rhythm Disease Management | 2021-08-12 |
| SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S131) | Edwards Lifesciences, LLC | 2021-08-12 |
| AngioJet Thrombectomy System (P980037/S086) | Boston Scientific Corp | 2021-08-12 |
| Integra Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template (P900033/S097) | Integra Lifesciences Corp. | 2021-08-12 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S488) | Medtronic Neuromodulation | 2021-08-12 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S480) | Medtronic, Inc. | 2021-08-12 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S479) | Medtronic, Inc. | 2021-08-12 |
| Medtronic Evolut FX System (P130021/S094) | Medtronic, Inc. | 2021-08-12 |
| HeartWare HVAD System (P100047/S174) | Medtronic | 2021-08-12 |
| Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S099) | Integra LifeSciences Corporation | 2021-08-12 |
| 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 MR (P010031/S753) | Medtronic Cardiac Rhythm Disease Management | 2021-08-12 |
| CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S083) | Integra Lifesciences Corp. | 2021-08-12 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 (P060030/S086) | Roche Molecular Systems, Inc. | 2021-08-11 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S056) | Roche Molecular Systems, Inc. | 2021-08-11 |
| AutoDELFIA hAFP Test System (P970037/S012) | Revvity, Inc. | 2021-08-11 |
| LeukoStrat CDx FLT3 Mutation Assay (P160040/S009) | Invivoscribe Technologies, Inc. | 2021-08-11 |
| AngioJet Thrombectomy System (P980037/S085) | Boston Scientific Corp | 2021-08-11 |
| COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S085) | Roche Molecular Systems, Inc. | 2021-08-11 |
| LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX Control HBsAg Qual (P190017/S002) | DiaSorin, Inc. | 2021-08-10 |
| LIAISON XL MUREX Anti-HBc, LIAISON XL MUREX Control Anti-HBc (P180038/S005) | DiaSorin, Inc. | 2021-08-10 |
| CardioMEMS HF System (P100045/S053) | ABBOTT MEDICAL | 2021-08-10 |
| HeartWare HVAD System (P100047/S188) | Medtronic | 2021-08-10 |
| LIAISON XL MUREX Anti-HBe, LIAISON XL MUREX Control Anti-HBe (P180049/S002) | DiaSorin, Inc. | 2021-08-10 |
| LIAISON QuantiFERON-TB Gold Plus, LIAISON XL Control QuantiFERON-TB Gold Plus (P180047/S010) | DiaSorin, Inc. | 2021-08-10 |