| AcrySof Posterior Chamber Intraocular Lens (P930014/S132) | Alcon Laboratories, Inc. | 2021-02-18 |
| WaveLlght EX500 Laser System (P030008/S033) | Alcon Laboratories, Inc. | 2021-02-18 |
| Orchestra/Orchestra Plus C3PR/C3PRH, Orchestra Plus Link, USB adapter for CPR3H, Smart ECG (P980049/S137) | MicroPort CRM USA, Inc. | 2021-02-18 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (with the AutonoMe Pre-Loaded Delivery System) Claeron Toric Asphe (P190018/S005) | Alcon Laboratories, LLC | 2021-02-18 |
| Mobi-C Cervical Disc Prosthesis One-level (P110002/S029) | Highridge Medical, LLC | 2021-02-17 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S016) | Berlin Heart, Inc. | 2021-02-17 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.5 with SmartAssist, and Impella 5.0/LD (P140003/S079) | Abiomed, Inc. | 2021-02-17 |
| ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S014) | Biotronik AG | 2021-02-17 |
| AngelMed Guardian System (P150009/S005) | Avertix Medical, Inc. | 2021-02-17 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S028) | C.R. Bard, Inc. | 2021-02-17 |
| Mobi-C Cervical Disc Prosthesis Two-level (P110009/S029) | Highridge Medical, LLC | 2021-02-17 |
| SpF Implantable Spinal Fusion Stimulators (P850035/S056) | Ahp Eos Buyer, Inc. | 2021-02-17 |
| SAPIEN 3 Transcatheter Heart Valve System (P200015/S005) | Edwards Lifesciences, LLC | 2021-02-17 |
| EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S067) | Ahp Eos Buyer, Inc. | 2021-02-17 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S673) | Medtronic, Inc. | 2021-02-17 |
| SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S126) | Edwards Lifesciences, LLC | 2021-02-17 |
| Minerva Endometrial Ablation System (P140013/S012) | Axora Medical, Inc. | 2021-02-17 |
| Avitene Microfibrillar Collagen Hemostat (N17600/S035) | Davol Inc., Sub. C. R. Bard, Inc. | 2021-02-17 |
| Micra AV TPS, Micra TPS (P150033/S094) | Medtronic, Inc. | 2021-02-16 |
| LIFEPAK CR2 Automated External Defibrillator (P170018/S012) | Physio-Control, Inc. | 2021-02-16 |
| BD PrepStain System (P970018/S037) | Bd Diagnostic Systems | 2021-02-16 |
| Silikon 1000 (P950008/S015) | Alcon | 2021-02-15 |
| OPRA Implant System (P190009/S001) | Integrum AB | 2021-02-12 |
| HeartWare HVAD System (P100047/S149) | Medtronic | 2021-02-12 |
| Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039) | Shockwave Medical, Inc. | 2021-02-12 |
| HeartStart FRx Defibrillator (P180028/S006) | Philips Medical Systems | 2021-02-12 |
| HeartStart Home Defibrillator and HeartStart OnSite Defibrillator (P160029/S009) | Philips Medical Systems, Inc. | 2021-02-12 |
| Prismaflex TPE2000 Set (P830063/S013) | Vantive US Healthcare, LLC | 2021-02-12 |
| OPRA System (P190009/S002) | Integrum AB | 2021-02-12 |
| CareLink SmartSync Azure Astra Application (P980035/S670) | Medtronic, Inc. | 2021-02-12 |
| CareLink SmartSync Percepta Serena Solara Application (P010015/S464) | Medtronic, Inc. | 2021-02-12 |
| Inspire Programmer System (P130008/S056) | Inspire Medical Systems | 2021-02-12 |
| Progel Pleural Air Leak Sealant (Progel PALS) (P010047/S064) | Neomend, Inc. | 2021-02-11 |
| Tridyne Vascular Sealant (Tridyne VS) (P150016/S020) | Neomend, Inc. | 2021-02-11 |
| Arctic Front Cardiac CryoAblation System: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoabl (P100010/S108) | Medtronic Cryocath, LP | 2021-02-11 |
| VICI VENOUS STENT System and VICI RDS Stent System (P180013/S006) | Boston Scientific Corporation | 2021-02-11 |
| Itrel®, Synergy® and Intellis Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vectris® Spinal Cord Stimulati (P840001/S483) | Medtronic Neuromodulation | 2021-02-10 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S003) | Boston Scientific Corporation | 2021-02-10 |
| RHA 2, RHA 3, RHA 4 Dermal Fillers (P170002/S010) | Teoxane S.A. | 2021-02-10 |
| Activa® Deep Brain Stimulation Therapy System (P960009/S395) | Medtronic, Inc. | 2021-02-10 |
| WATCHMAN and WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S041) | Boston Scientific Corp | 2021-02-10 |
| Simplify Cervical Artificial Disc (P200022/S004) | Nuvasive, Inc. | 2021-02-10 |
| SelectSecure Lead (P030036/S129) | Medtronic Cardiac Rhythm Disease Management | 2021-02-09 |
| CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S153) | Medtronic Cardiac Rhythm Disease Management | 2021-02-09 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, (P980035/S663) | Medtronic, Inc. | 2021-02-09 |
| Attain Ability Lead (P080006/S157) | Medtronic, Inc. | 2021-02-09 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S458) | Medtronic, Inc. | 2021-02-09 |
| 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, Compia (P010031/S724) | Medtronic Cardiac Rhythm Disease Management | 2021-02-09 |
| Attain Ability Straight Left Ventricular Lead (P080006/S156) | Medtronic, Inc. | 2021-02-09 |
| Attain Bipolar OTW Lead (P010015/S465) | Medtronic, Inc. | 2021-02-09 |
| Micra AV TPS, Micra TPS (P150033/S088) | Medtronic, Inc. | 2021-02-09 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, M (P980016/S764) | Medtronic Cardiac Rhythm Disease Management | 2021-02-09 |
| MyCareLink Patient Monitor (P890003/S438) | Medtronic, Inc. | 2021-02-09 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S192) | Medtronic Cardiac Rhythm Disease Management | 2021-02-09 |
| Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil (P040029/S019) | Euclid Vision Corporation | 2021-02-08 |
| Infuse Bone Graft (P050053/S055) | Medtronic, Inc. | 2021-02-08 |
| Infuse Bone Graft (P000054/S064) | Medtronic Sofamor Danek USA, Inc. | 2021-02-05 |
| Rotablator or ROTAPRO Rotational Atherectomy System (P900056/S183) | Boston Scientific Corp | 2021-02-05 |
| PROMUS Element Plus Everolimus-Eluting Coronary Stent System, Promus PREMIER Everolimus-Eluting Coronary Stent System, P (P110010/S187) | Boston Scientific Corp | 2021-02-05 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S038) | Nevro Corporation | 2021-02-05 |
| Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S083) | Medtronic Sofamor Danek USA, Inc. | 2021-02-05 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S042) | Medtronic Vascular | 2021-02-04 |
| Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil (P040029/S016) | Euclid Vision Corporation | 2021-02-04 |
| IN.PACT AV Paclitaxel-Coated PTA Balloon Catheter (P190008/S009) | Medtronic Vascular, Inc. | 2021-02-04 |
| Helistat® and Helitene® Absorbable Collagen Hemostatic Agents (P850010/S093) | Integra LifeSciences Corporation | 2021-02-04 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S106) | Medtronic Vascular | 2021-02-04 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S055) | Medtronic, Inc. | 2021-02-04 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collaslat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S093) | Integra LifeSciences Corporation | 2021-02-04 |
| Genesis Neurostimulation System (P010032/S170) | ABBOTT MEDICAL | 2021-02-03 |
| Axonics Sacral Neuromodulation System (P180046/S026) | Boston Scientific Corporation | 2021-02-03 |
| Axonics Sacral Neuromodulation System (P190006/S026) | Boston Scientific Corporation | 2021-02-03 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MRI CRT-D (P010031/S729) | Medtronic Cardiac Rhythm Disease Management | 2021-02-03 |
| Elecsys Anti-HBe, PreciControl Anti-HBe (P190005) | Roche Diagnostics | 2021-02-03 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MRI CRT-D (P980016/S767) | Medtronic Cardiac Rhythm Disease Management | 2021-02-03 |
| Powerheart® G5 AED (P160033/S005) | ZOLL Medical Corporation | 2021-02-02 |
| Contak Renewal (P030005/S205) | Guidant Corp. | 2021-02-02 |
| Pulsar/Pulsar Max Implantable Pulse Generator System with Consult Software (N970003/S259) | Boston Scientific Corp | 2021-02-02 |
| LATITUDE Programming System (P910077/S182) | Boston Scientific | 2021-02-02 |
| AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) (P190013) | Aed Battery Exchange, LLC | 2021-02-02 |
| Thermocool SF NAV, Celsius Thermocool, EZ Steer Thermocool, EZ Steer Thermocool Bi-Directional, and Navistar Thermocool (P030031/S112) | Biosense Webster, Inc. | 2021-02-02 |
| Celsius Fluter, NavistarDS Diagnostic, Celsius DS, EZ Steer Nav DS (P010068/S061) | Biosense Webster, Inc. | 2021-02-02 |
| Navistar EP, EZ Steer Nav Bi-Directional (P990025/S061) | Biosense Webster, Inc. | 2021-02-02 |
| Subcutaneous Implantable Defibrillator(S-ICD) System (P110042/S150) | Boston Scientific Corporation | 2021-02-02 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel Programming Systems) (P080025/S217) | Medtronic Neuromodulation | 2021-02-02 |
| Ventak AV AICD, Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioveter Defibrillator Syste (P960040/S460) | Boston Scientific | 2021-02-02 |
| Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill (P010012/S529) | Boston Scientific Corp | 2021-02-02 |
| Imageready MR Conditional Pacing System and Ingevity PACE/SENSE Lead (P150012/S104) | Boston Scientific | 2021-02-02 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary Programming Systems) (P970004/S322) | Medtronic Neuromodulation | 2021-02-02 |
| Celsius, Celsius Flutter, EZ Steer (P950005/S076) | Biosense Webster, Inc. | 2021-02-02 |
| EZ Steer Thermocool, EZ Steer Thermocool Bi-Directional, Navistar Thermocool (P040036/S077) | Biosense Webster, Inc. | 2021-02-02 |
| Gore Excluder Conformable AAA Endoprosthesis (P200030/S001) | W. L. Gore and Associates, Inc. | 2021-02-01 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S475) | Medtronic Neuromodulation | 2021-01-29 |
| LifeVest Wearable Defibrillator (P010030/S144) | Zoll Manufacturing Corporation | 2021-01-29 |
| Restylane Defyne (P140029/S027) | Q-Med AB | 2021-01-29 |
| NaviStar THERMOCOOL Deflectable Diagnostic/Ablation Catheter (P030031/S102) | Biosense Webster, Inc. | 2021-01-28 |
| Percepta Bipolar, Percepta Quadripolar, Serena Bipolar, Serena Quadripolar, Solara Bipolar, and Solara Quadripolar dual (P010015/S456) | Medtronic, Inc. | 2021-01-28 |
| Astra S DR MRI, Astra S SR MRI, Astra XT DR MRI, Astra XT SR MRI, Azure S DR MRI, Azure S SR MRI, Azure XT DR MRI, Azure (P980035/S659) | Medtronic, Inc. | 2021-01-28 |
| DiamondTemp Ablation System (P200028) | Medtronic, Inc. | 2021-01-28 |
| EZ Steer ThermoCool Nav Deflectable Diagnostic/Ablation Catheter (P040036/S070) | Biosense Webster, Inc. | 2021-01-28 |
| Mara Water Vapor Probe (P160047/S020) | CooperSurgical, Inc. | 2021-01-27 |