| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P180046/S033) | Boston Scientific Corporation | 2021-03-16 |
| AMS 700 Inflatable Penile Prosthesis (N970012/S185) | Boston Scientific Corp | 2021-03-16 |
| Tack Endovascular System (P180034/S004) | Philips Image Guided Therapy Corporation | 2021-03-16 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S739) | Medtronic Cardiac Rhythm Disease Management | 2021-03-16 |
| Micra AV TPS, Micra TPS (P150033/S097) | Medtronic, Inc. | 2021-03-16 |
| 13 C-Spirulina Gastric Emptying Breath Test (GEBT) (P110015/S007) | Advanced Breath Diagnostics | 2021-03-16 |
| GELSYN-3 (P110005/S008) | Ibsa Institut Biochimique SA | 2021-03-15 |
| prodisc L (P050010/S023) | Centinel Spine, LLC | 2021-03-15 |
| Ranger Over-The-Wire Paclitaxel-Coated PTA Balloon Catheter (P190019/S007) | Boston Scientific Corporation | 2021-03-15 |
| Clareon PanOptix Trifocal Hydrophobic IOL, Clareon PanOptix Trifocal UV Absorbing IOL, Clareon PanOptix Trifocal Hydroph (P190018/S009) | Alcon Laboratories, LLC | 2021-03-15 |
| Scandinavian Total Ankle Replacement (STAR Ankle) (P050050/S017) | Djo Global | 2021-03-15 |
| CardioMEMS HF System (P100045/S047) | ABBOTT MEDICAL | 2021-03-12 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S076) | Abiomed, Inc. | 2021-03-12 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst (P130021/S087) | Medtronic, Inc. | 2021-03-12 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S044) | Medtronic Vascular | 2021-03-12 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S471) | Medtronic, Inc. | 2021-03-12 |
| Livewire TC Steerable Electrophysiology Catheter, Safire Bi-directional Ablation Catheter (P960016/S086) | St Jude Medical | 2021-03-12 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S013) | Medtronic Vascular, Inc. | 2021-03-12 |
| Impella RP (P170011/S027) | Abiomed, Inc. | 2021-03-12 |
| Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters (P040042/S048) | Irvine Biomedical,Inc.(Ibi) | 2021-03-12 |
| Cobalt MRI ICD, CObalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/SR ICD, Evera XT DR/VR I (P980016/S776) | Medtronic Cardiac Rhythm Disease Management | 2021-03-12 |
| 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 (P010031/S738) | Medtronic Cardiac Rhythm Disease Management | 2021-03-12 |
| Integrity Coronary Stent System (P030009/S100) | Medtronic, Ireland | 2021-03-12 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Attesta D (P980035/S678) | Medtronic, Inc. | 2021-03-12 |
| Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters (P060019/S050) | Irvine Biomedical, Inc. | 2021-03-12 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S058) | Medtronic, Inc. | 2021-03-12 |
| TactiCath Quartz Catheter and TactiSys Quartz Equipment (P130026/S068) | St Jude Medical | 2021-03-12 |
| Therapy Ablation Catheters (P040014/S042) | Irvine Biomedical, Inc. | 2021-03-12 |
| Therapy Cool Path Duo, Safire BLU Duo, Cool Path, Duo, Safire Duo, Therapy Cool Path Duo SP, Safire, BLU Duo SP and Ther (P110016/S073) | ABBOTT MEDICAL | 2021-03-12 |
| Endurant Stent Grafyt System, Endurant II Stent Graft System, Ednurant II AUI Stent Graft System, Endurant IIs Stent Gra (P100021/S088) | Medtronic Vascular | 2021-03-12 |
| Resolute Integrity zotarolimus-Eluting Coronary Stent Systems (P110013/S108) | Medtronic Vascular | 2021-03-12 |
| Inspire II Upper Airway Stimulator (P130008/S063) | Inspire Medical Systems | 2021-03-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Navion Thoracic Stent Graft System and Valiant T (P100040/S045) | Medtronic Vascular | 2021-03-12 |
| ADVIA Centaur Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM He (P030040/S019) | Siemens Healthcare Diagnostics | 2021-03-11 |
| HeartWare HVAD System (P100047/S175) | Medtronic | 2021-03-11 |
| IMMULITE 2000/2000 XPi Anti-HBc IgM (P010053/S013) | Siemens Healthcare Diagnostics Products, Ltd. | 2021-03-11 |
| ADVIA Centaur HBc Total ReadyPack Reagents, ADVIA Centaur HBc Total Quality Control Materials, Atellica IM Anti-Hepatiti (P040004/S019) | Siemens Healthcare Diagnostics | 2021-03-11 |
| ADVIA Centaur HBsAg ReadyPack Reagents/ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, ADVIA Centaur HBsAg Quality (P030049/S016) | Siemens Healthcare Diagnostics | 2021-03-11 |
| IMMULITE 2000/2000 XPi Anti-HBc (P010051/S014) | Siemens Healthcare Diagnostics Products, Ltd. | 2021-03-11 |
| ADVIA Centaur HCV ReadyPack Reagents, Atellica IM Hepatitis C (aHCV), Atellica IM Hepatitis C Quality Control(aHCV QC) (P030056/S019) | Siemens Healthcare Diagnostics | 2021-03-11 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S159) | Medtronic, Inc. | 2021-03-11 |
| ADVIA Centaur anti-HBs2 (aHBs2), ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material, Atellica IM Anti-Hepatitis B (P100039/S011) | Siemens Healthcare Diagnostics, Inc. | 2021-03-11 |
| ADVIA Centaur HBsAg II(HBsII), ADVIA Centaur HBsAg Confirmatory, ADVIA Centaur HBsAg Quality Control Material, Atellica (P110041/S011) | Siemens Corp. | 2021-03-11 |
| Hintermann Series H3 Total Ankle Replacement System (P160036/S002) | Dt Medtech, LLC | 2021-03-11 |
| Reply SR, Reply DR (P950029/S131) | MicroPort CRM USA, Inc. | 2021-03-10 |
| HeartStart OnSite Defibrillator and HeartStart Home Defibrillator (P160029/S010) | Philips Medical Systems, Inc. | 2021-03-10 |
| THxID-BRAF kit (P120014/S011) | bioMerieux, Inc. | 2021-03-10 |
| HeartStart FRx Defibrillator (P180028/S007) | Philips Medical Systems | 2021-03-10 |
| RxSight Light Adjustable Lens and Light Delivery Device (P160055/S017) | Rxsight, Inc. | 2021-03-10 |
| Impella 2.5 System, Impella CP System and Impella CP System with SmartAssist System, Impella 5.0 System, Impella LD Syst (P140003/S074) | Abiomed, Inc. | 2021-03-10 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 (P060030/S085) | Roche Molecular Systems, Inc. | 2021-03-09 |
| MitraClip NT Clip Delivery System, MitraClip XT Clip Delivery System, and MitraClip G4 Clip Delivery System (P100009/S039) | ABBOTT MEDICAL | 2021-03-09 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S055) | Roche Molecular Systems, Inc. | 2021-03-09 |
| CardioMEMS HF System (P100045/S048) | ABBOTT MEDICAL | 2021-03-09 |
| Optune System (P100034/S027) | Novocure, GmbH | 2021-03-09 |
| Optune System (P100034/S025) | Novocure, GmbH | 2021-03-09 |
| COBAS AmpliPrep/COBAS TaqMan HBV Test, V2.0 (P050028/S084) | Roche Molecular Systems, Inc. | 2021-03-09 |
| AED Plus (P160015/S010) | ZOLL Medical Corporation | 2021-03-09 |
| Phylax AV ICD System (P000009/S086) | Biotronik, Inc. | 2021-03-08 |
| Renamic Neo Programmer (P950037/S213) | Biotronik, Inc. | 2021-03-08 |
| TECNIS Symfony Toric II OptiBlue Extended Range of Vision (ERV) IOLs (P980040/S131) | Johnson & Johnson Surgical Vision, Inc. | 2021-03-08 |
| 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, Ev (P980016/S771) | Medtronic Cardiac Rhythm Disease Management | 2021-03-08 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S468) | Medtronic, Inc. | 2021-03-08 |
| Tupos LV/ATX & Kronos LV-T CRT-D & Corox OWT Steroid LV Pacing Lead (P050023/S148) | Biotronik, Inc. | 2021-03-08 |
| 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/S733) | Medtronic Cardiac Rhythm Disease Management | 2021-03-08 |
| Stratos LV CRT-P and Stratos LV-T CRT-P, Corox OTW BP Lead and Corox OTW-S BP Lead (P070008/S116) | Biotronik, Inc. | 2021-03-08 |
| 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/S672) | Medtronic, Inc. | 2021-03-08 |
| DiamondTemp Ablation Catheters (P200028/S001) | Medtronic, Inc. | 2021-03-08 |
| Alinity m HBV (P200013/S004) | Abbott Molecular, Inc. | 2021-03-08 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S036) | Nevro Corporation | 2021-03-06 |
| Abbott RealTime CMV (P160044/S003) | Abbott Molecular | 2021-03-05 |
| Abbott RealTime HCV Genotype II (P120012/S019) | Abbott Molecular | 2021-03-05 |
| Trident Ceramic System (P000013/S018) | Howmedica Osteonics Corp. | 2021-03-05 |
| SYNERGY, SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S070) | Boston Scientific Corporation | 2021-03-05 |
| Infinity family of DBS IPGs (P140009/S064) | ABBOTT MEDICAL | 2021-03-05 |
| Proclaim DRG IPG (P150004/S043) | ABBOTT MEDICAL | 2021-03-05 |
| Abbott RealTime HBV (P080026/S024) | Abbott Molecular, Inc. | 2021-03-05 |
| Abbott RealTime HCV (P100017/S024) | Abbott Molecular, Inc. | 2021-03-05 |
| Deep Brain Stimulation Multilead Trial Cable (DBS MLTC) (P140009/S066) | ABBOTT MEDICAL | 2021-03-05 |
| Intellis Spinal Cord Stimulation Systems; Specify and Vectris Spinal Cord Stimulation Leads; Injex lead anchors (P840001/S480) | Medtronic Neuromodulation | 2021-03-05 |
| Proclaim family of SCS IPGs (P010032/S168) | ABBOTT MEDICAL | 2021-03-05 |
| PROMUS Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S189) | Boston Scientific Corp | 2021-03-05 |
| Alinity m HCV (P190025/S005) | Abbott Molecular, Inc. | 2021-03-05 |
| Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S010) | Stryker Leibinger GmbH & Co KG | 2021-03-05 |
| Alinity m HBV (P200013/S003) | Abbott Molecular, Inc. | 2021-03-05 |
| CapSure Epicardial Pacing Lead (P950024/S098) | Medtronic, Inc. | 2021-03-04 |
| HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead (P920015/S253) | Medtronic, Inc. | 2021-03-04 |
| CapSureFix MRI Lead (P090013/S314) | Medtronic, Inc. | 2021-03-04 |
| Myocardial Pacing Lead (P120017/S027) | Medtronic, Inc. | 2021-03-04 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S442) | Medtronic, Inc. | 2021-03-04 |
| GORE VIATORR TIPS Endoprosthesis, GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S084) | W. L. Gore & Associates, Inc. | 2021-03-04 |
| SelectSecure Lead (P030036/S130) | Medtronic Cardiac Rhythm Disease Management | 2021-03-04 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S154) | Medtronic Cardiac Rhythm Disease Management | 2021-03-04 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S193) | Medtronic Cardiac Rhythm Disease Management | 2021-03-04 |
| Axonics Sacral Neuromodulation (SNM) System for Urinary Control (P190006/S032) | Boston Scientific Corporation | 2021-03-04 |
| GORE VIATORR TIPS Endoprosthesis, GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S085) | W. L. Gore & Associates, Inc. | 2021-03-04 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, S (P010015/S466) | Medtronic, Inc. | 2021-03-04 |
| Transvene CS/SVC Lead (P980050/S132) | Medtronic, Inc. | 2021-03-04 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S223) | Medtronic, Inc. | 2021-03-04 |
| Epicardial Patch Lead (P900061/S164) | Medtronic Cardiac Rhythm Disease Management | 2021-03-04 |