| Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent (P200015/S011) | Edwards Lifesciences, LLC | 2021-12-16 |
| Elecsys HBsAg II (P160019/S013) | Roche Diagnostics, Inc. | 2021-12-16 |
| Elecsys Anti-HBs (P010054/S041) | Roche Diagnostics Corp. | 2021-12-16 |
| Elecsys Anti-HBs II (P190034/S001) | Roche Diagnostics | 2021-12-16 |
| Venovo Venous Stent System (P180037/S008) | Bard Peripheral Vascular, Inc. | 2021-12-16 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, Medt (P130021/S107) | Medtronic, Inc. | 2021-12-16 |
| Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S045) | ABBOTT MEDICAL | 2021-12-16 |
| Harmony Transcatheter Pulmonary Valve (P200046/S006) | Medtronic, Inc. | 2021-12-16 |
| Lutonix Drug Coated Balloon PTA Catheter (P170003/S024) | Lutonix | 2021-12-16 |
| Biocor, Biocor Supra, Epic, Epic Supra, Epic Plus, Epic Plus Supra (P040021/S048) | ABBOTT MEDICAL | 2021-12-16 |
| Portico Transcatheter Heart Valve (P190023/S004) | ABBOTT MEDICAL | 2021-12-16 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S080) | Boston Scientific Corporation | 2021-12-16 |
| Gore Excluder Conformable AAA Endoprosthesis (EXCC) (P200030/S006) | W. L. Gore and Associates, Inc. | 2021-12-16 |
| GORE®1 EXCLUDER® AAA Endoprosthesis (AAA), GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) (P020004/S186) | W. L. Gore & Associates, Inc. | 2021-12-16 |
| OPTIMIZER Smart Mini System (P180036/S011) | Impulse Dynamics (Usa), Inc. | 2021-12-16 |
| NeuroPace® RNS® System (P100026/S089) | NeuroPace, Inc. | 2021-12-16 |
| Arctic Front Cardiac CryoAblation System: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoabl (P100010/S118) | Medtronic Cryocath, LP | 2021-12-16 |
| InterStim® Therapy System, Verify® Evaluation System, InterStim Micro Implantable Neurostimulator (P080025/S243) | Medtronic Neuromodulation | 2021-12-15 |
| Cordis® EXOSEAL® Vascular Closure Device (P100013/S023) | Cordis US Corporation | 2021-12-15 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S073) | Zimmer, Inc. | 2021-12-15 |
| ARCHITECT HBsAg Qualitative/Confirmatory / Alinity i HBsAg Qualitative II/Confirmatory (P110029/S036) | Abbott Laboratories | 2021-12-15 |
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S036) | Abbott Laboratories | 2021-12-15 |
| Innova Vascular Self-Expanding Stent System (P140028/S072) | Boston Scientific Corporation | 2021-12-15 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S046) | Abbott Laboratories | 2021-12-15 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S383) | Medtronic, Inc. | 2021-12-15 |
| Zenith® Dissection Endovascular System (P180001/S003) | William Cook Europe Aps | 2021-12-15 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense Implantable Neurostimulator (P960009/S414) | Medtronic, Inc. | 2021-12-15 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S048) | Boston Scientific Corp | 2021-12-15 |
| InterStim® Therapy System, Verify® Evaluation System, InterStim Micro Implantable Neurostimulator (P970004/S348) | Medtronic Neuromodulation | 2021-12-15 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S057) | Abbott Laboratories | 2021-12-15 |
| ARCHITECT Anti-HCV / Alinity i Anti-HCV (P050042/S047) | Abbott Laboratories, Inc. | 2021-12-15 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S034) | Abbott Laboratories | 2021-12-15 |
| Master Restore, Itrel®, Synergy® and Intellis Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® Spina (P840001/S504) | Medtronic Neuromodulation | 2021-12-15 |
| ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S045) | Abbott Laboratories, Inc. | 2021-12-15 |
| Arctic Front Advance, Arctic Front Advance Pro (P100010/S122) | Medtronic Cryocath, LP | 2021-12-14 |
| Resolute Integrity RX and OTW Zotarolimus-Eluting Coronary Stent System (P110013/S113) | Medtronic Vascular | 2021-12-14 |
| Restylane-L, Restylane Lyft, Restylane Silk (P040024/S129) | Q-Med AB | 2021-12-14 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S047) | Boston Scientific Corp | 2021-12-14 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System RX and OTW (P160043/S049) | Medtronic Vascular | 2021-12-14 |
| Integrity Coronary Stent System RX and OTW (P030009/S105) | Medtronic, Ireland | 2021-12-14 |
| Perlane, Restylane (P040024/S130) | Q-Med AB | 2021-12-14 |
| Precision Spinal Cord Stimulator {SCS) Systems (P030017/S349) | Boston Scientific Corp | 2021-12-14 |
| HV Splitter/Adaptor kit, Sprint Quattro Lead (P920015/S263) | Medtronic, Inc. | 2021-12-13 |
| G-Armor Stent, G-Armor Covered Stent, G-Armor Mounted Stent, G-Armor Covered Mounted Stent (P150028/S006) | NuMED, Inc. | 2021-12-13 |
| QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus (P010033/S047) | Qiagen | 2021-12-13 |
| MynxGrip Vascular Closure Device (SF, 6F/7F), Mynx Control Vascular Closure Device (SF, 6F/7F) (P040044/S090) | Cordis US Corporation | 2021-12-13 |
| SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Ex (P210014) | Advanced Bifurcation Systems, Inc. | 2021-12-13 |
| Cologuard® (P130017/S050) | Exact Sciences Corporation | 2021-12-13 |
| Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprostheses (P860057/S202) | Edwards Lifesciences, LLC | 2021-12-13 |
| Portico TAVI System (P190023/S003) | ABBOTT MEDICAL | 2021-12-13 |
| Valiant Captivia Stent Graft ith the Captivia Delivery System (P100040/S050) | Medtronic Vascular | 2021-12-10 |
| Floseal Hemostatic Matrix (FLOSEAL) (P990009/S068) | Baxter Healthcare Corp | 2021-12-10 |
| MENTOR MemoryShape Breast Implants (P060028/S042) | Mentor Worldwide, LLC | 2021-12-10 |
| IntellaTip MiFi OI, IntellaNav MiFi OI, IntellaNav OI, Blazer OI (P150005/S068) | Boston Scientific Corp | 2021-12-10 |
| MemoryGel BOOST Moderate Plus Profile Breast Implants and MemoryGel BOOST High Profile BOOST Breast Implants (P030053/S051) | Mentor Corp. | 2021-12-10 |
| Cartiva Synthetic Cartilage Implant (SCI) (P150017/S015) | Cartiva, Inc. | 2021-12-10 |
| MENTOR MemoryGel Breast Implants (P030053/S063) | Mentor Corp. | 2021-12-10 |
| Biofinity Sphere, Biofinity Toric (P080011/S136) | CooperVision, Inc. | 2021-12-10 |
| Carotid Wallstent Monorail Endoprosthesis (P050019/S033) | Boston Scientific Corp | 2021-12-10 |
| Inspire Programmer System (P130008/S072) | Inspire Medical Systems | 2021-12-10 |
| IN.PACT® AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S017) | Medtronic Vascular, Inc. | 2021-12-09 |
| 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/S697) | Medtronic, Inc. | 2021-12-09 |
| IN.PACT® Admiral® Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S063) | Medtronic, Inc. | 2021-12-09 |
| Amplatzer Amulet LAA Occluder (P200049/S002) | ABBOTT MEDICAL | 2021-12-09 |
| Micra AV TPS, Micra TPS (P150033/S129) | Medtronic, Inc. | 2021-12-09 |
| Masters HP Valved Graft with Gelweave Valsalva Technology (VAVGJ) (P810002/S115) | ABBOTT MEDICAL | 2021-12-09 |
| NEO 2101.U (P000009/S092) | Biotronik, Inc. | 2021-12-09 |
| NEO 2101.U (P950037/S225) | Biotronik, Inc. | 2021-12-09 |
| 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/S766) | Medtronic Cardiac Rhythm Disease Management | 2021-12-09 |
| ORSIRO Mission Sirolimus Eluting Coronary Stent System (P170030/S020) | Biotronik AG | 2021-12-09 |
| Restylane® Refyne, Restylane® Defyne, Restylane® Kysse, Restylane® Contour (P140029/S044) | Q-Med AB | 2021-12-09 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S487) | Medtronic, Inc. | 2021-12-09 |
| BioGlue® Surgical Adhesive (P010003/S039) | Cryolife, Inc. | 2021-12-09 |
| 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/S800) | Medtronic Cardiac Rhythm Disease Management | 2021-12-09 |
| VenaSeal Closure System (P140018/S030) | Medtronic Vascular, Inc. | 2021-12-09 |
| Elecsys HBsAg Confirmatory Test (P160019/S012) | Roche Diagnostics, Inc. | 2021-12-09 |
| NEO 2101.U (P050023/S157) | Biotronik, Inc. | 2021-12-09 |
| Restylane® Injectable Gel (P040024/S128) | Q-Med AB | 2021-12-09 |
| Preveleak Surgical Sealant, Preveleak Delivery Tips - 1O pack (P100030/S016) | Baxter Healthcare Corporation | 2021-12-09 |
| TherOx DownStream System (P170027/S006) | Zoll Circulation, Inc. | 2021-12-09 |
| OrganOx metra System (P200035) | Organox Limited | 2021-12-09 |
| NEO 2101.U (P070008/S126) | Biotronik, Inc. | 2021-12-09 |
| NovaSure Impedance Controlled Endometrial Ablation System (P010013/S082) | Hologic, Inc. | 2021-12-09 |
| LCS® Total Knee System (P830055/S276) | Depuy, Inc. | 2021-12-09 |
| CERAMAX (R) Ceramic Total Hip System (P070026/S088) | DePuy Orthopaedics, Inc. | 2021-12-09 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S017) | Smith & Nephew, Inc. | 2021-12-08 |
| Master InterStim Therapy System, Verify Evaluation System (P970004/S349) | Medtronic Neuromodulation | 2021-12-08 |
| Belotero Balance + Lidocaine Dermal Filler, Belotero Balance Dermal Filler (P090016/S045) | Merz North America, Inc. | 2021-12-08 |
| XACT Carotid Stent System (P040038/S039) | Abbott Vascular, Inc. | 2021-12-08 |
| Tendril STS Pacing Leads (P960013/S118) | ABBOTT MEDICAL | 2021-12-08 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S123) | Vistakon, Division of Johnson & Johnson Vision Car | 2021-12-08 |
| RX Acculink Carotid Stent System (P040012/S063) | Abbott Vascular | 2021-12-08 |
| InterStim Therapy System, Verify Evaluation System (P080025/S244) | Medtronic Neuromodulation | 2021-12-08 |
| Belotero Balance + Lidocaine Dermal Filler, Belotero Balance Dermal Filler (P090016/S044) | Merz North America, Inc. | 2021-12-08 |
| RX Herculink Elite Renal Stent System (P110001/S017) | Abbott Vascular | 2021-12-08 |
| CapSure Epicardial Pacing Lead (P950024/S101) | Medtronic, Inc. | 2021-12-07 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Stylet Kit, Vitatron Impulse II Lead (P850089/S159) | Medtronic Cardiac Rhythm Disease Management | 2021-12-07 |
| Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Stylet Kit, Vitatron Crystalline Lead (P830061/S200) | Medtronic Cardiac Rhythm Disease Management | 2021-12-07 |
| ACE Header End Cap, Epicardial Patch Lead, Upsizing Sleeve (P900061/S167) | Medtronic Cardiac Rhythm Disease Management | 2021-12-07 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena (P010015/S486) | Medtronic, Inc. | 2021-12-07 |