| HV Splitter/Adapter kit, Sprint Quattro Lead (P920015/S252) | Medtronic, Inc. | 2021-03-04 |
| 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/S769) | Medtronic Cardiac Rhythm Disease Management | 2021-03-04 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P180046/S032) | Boston Scientific Corporation | 2021-03-04 |
| On-X Prosthetic Heart Valve and On-X Ascending Aortic Prosthesis devices (P000037/S057) | On-X Life Technologies, Inc. | 2021-03-04 |
| 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/S731) | Medtronic Cardiac Rhythm Disease Management | 2021-03-04 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S158) | Medtronic, Inc. | 2021-03-04 |
| Attain StarFix Lead (P060039/S106) | Medtronic, Inc. | 2021-03-04 |
| Plasmaflo OP-05W(A) (P820033/S014) | Asahi Kasei Medical Co., Ltd. | 2021-03-03 |
| iStent inject Trabecular Micro-Bypass System (P170043/S008) | Glaukos Corporation | 2021-03-03 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S041) | Boston Scientific Corp | 2021-03-03 |
| 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/S671) | Medtronic, Inc. | 2021-03-03 |
| Micra AV TPS, Micra TPS (P150033/S093) | Medtronic, Inc. | 2021-03-03 |
| 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/S770) | Medtronic Cardiac Rhythm Disease Management | 2021-03-03 |
| MetriQ Pump (P150005/S062) | Boston Scientific Corp | 2021-03-03 |
| 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/S732) | Medtronic Cardiac Rhythm Disease Management | 2021-03-03 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S057) | Alcon Research, Ltd. | 2021-03-03 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Relia IPG (P980035/S675) | Medtronic, Inc. | 2021-03-03 |
| Abbott RealTime IDH1 (P170041/S005) | Abbott Molecular, Inc. | 2021-03-03 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S467) | Medtronic, Inc. | 2021-03-03 |
| Epic Self Expanding Stent System (P110035/S065) | Boston Scientific Corp | 2021-03-03 |
| Arctic Front Advance and Arctic Front Advance Pro (P100010/S113) | Medtronic Cryocath, LP | 2021-03-03 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M (P980016/S773) | Medtronic Cardiac Rhythm Disease Management | 2021-03-03 |
| VENTANA ALK (D5F3) CDx Assay (P140025/S014) | Ventana Medical Systems, Inc. | 2021-03-03 |
| Restylane Refyne, Restylane Defyne, Restylane Kysse Injectable Gels (P140029/S036) | Q-Med AB | 2021-03-03 |
| Amplia MRl 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/S735) | Medtronic Cardiac Rhythm Disease Management | 2021-03-03 |
| Innova Self Expanding Stent System (P140028/S067) | Boston Scientific Corporation | 2021-03-03 |
| VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PRIVSC and VISCOAT) (P840064/S074) | Alcon Laboratories | 2021-03-03 |
| Abbott RealTime IDH2 (P170005/S003) | Abbott Molecular, Inc. | 2021-03-03 |
| Thermocool Smarttouch (P040036/S078) | Biosense Webster, Inc. | 2021-03-02 |
| Thermocool Smarttouch SF (P030031/S113) | Biosense Webster, Inc. | 2021-03-02 |
| Biofinity (comfilcon A) Soft (hydrophilic) Contact Lenses for Extended Wear (P080011/S123) | CooperVision, Inc. | 2021-03-02 |
| Prometra Programmable Infusion Pump System (P080012/S069) | Infusyn Therapeutics, LLC | 2021-03-02 |
| VenaSeal Closure System (P140018/S023) | Medtronic Vascular, Inc. | 2021-03-02 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extens (P100040/S044) | Medtronic Vascular | 2021-03-02 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P180046/S031) | Boston Scientific Corporation | 2021-03-02 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf (P100021/S087) | Medtronic Vascular | 2021-03-02 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S011) | Medtronic Vascular, Inc. | 2021-03-02 |
| Axonics Sacral Neuromodulation (SNM) System for Urinary Control (P190006/S031) | Boston Scientific Corporation | 2021-03-02 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S056) | Medtronic, Inc. | 2021-03-02 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Proo Delivery Catheter Sys (P130021/S086) | Medtronic, Inc. | 2021-03-02 |
| Axonics Sacral Neuromodulation (SNM) System Urinary Control (P190006/S030) | Boston Scientific Corporation | 2021-03-01 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S037) | Nevro Corporation | 2021-03-01 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P180046/S030) | Boston Scientific Corporation | 2021-03-01 |
| ezSert Preloaded Delivery System (P080004/S036) | Hoya Surgical Optics, Inc. | 2021-03-01 |
| Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S094) | Integra LifeSciences Corporation | 2021-02-26 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S111) | Abbott Vascular, Inc. | 2021-02-26 |
| iDesign Advanced WaveScan Studio, STAR Excimer Laser System (P930016/S062) | Amo Manufacturing USA, LLC | 2021-02-26 |
| Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S093) | Integra Lifesciences Corp. | 2021-02-26 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S094) | Integra LifeSciences Corporation | 2021-02-26 |
| CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S079) | Integra Lifesciences Corp. | 2021-02-26 |
| Evolut PRO+ Transcatheter Aortic Valves of the Evolut PRO+ System (P130021/S085) | Medtronic, Inc. | 2021-02-26 |
| Pipeline Flex Embolization Device (P100018/S031) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-02-26 |
| AF-1 Family of Intraocular Lens (IOL) (P080004/S033) | Hoya Surgical Optics, Inc. | 2021-02-26 |
| Nevro Corp Senza Spinal Cord Stimulation (SCS) System (P130022/S035) | Nevro Corporation | 2021-02-26 |
| Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. (P170013/S003) | MicroVention, Inc. | 2021-02-25 |
| Durasphere Injectable Bulking Agent (P980053/S018) | Carbon Medical Technologies, Inc. | 2021-02-25 |
| iPro2 CGM System with Enlite Glucose Sensor (P150029/S036) | Medtronic Minimed | 2021-02-25 |
| Guardian Connect system (P160007/S040) | Medtronic Minimed | 2021-02-25 |
| MiniMed 630G System with SmartGuard (P150001/S090) | Medtronic Minimed | 2021-02-25 |
| Paradigm Real-Time Revel System (P150019/S063) | Medtronic Minimed | 2021-02-25 |
| Defibtech Automated External Defibrillator (AED) Systems (P160032/S002) | Defibtech, LLC | 2021-02-25 |
| OraQuick HCV Rapid Antibody Test (P080027/S038) | OraSure Technologies, Inc. | 2021-02-25 |
| HEMOBLAST Bellows (P170012/S025) | Dilon Technologies, Inc. | 2021-02-25 |
| MiniMed 530G System (P120010/S139) | Medtronic, Inc. | 2021-02-25 |
| MiniMed 670G System and MiniMed 770G System (P160017/S090) | Medtronic Minimed, Inc. | 2021-02-25 |
| Cerene Cryotherapy Device (P180032/S003) | Channel Medsystems, Inc. | 2021-02-25 |
| Spinal Cord Stimulation (SCS) System (P010032/S169) | ABBOTT MEDICAL | 2021-02-24 |
| Life Pulse High Frequency Ventilator (P850064/S044) | Bunnell, Inc. | 2021-02-24 |
| PROMUS Everolimus-Eluting Coronary Stent System (P110010/S188) | Boston Scientific Corp | 2021-02-24 |
| OPTIGUIDE Cylindrical Fiber Optic (P940010/S017) | Pinnacle Biologics, Inc. | 2021-02-24 |
| Gelfoam Sterile Sponge (N18286/S037) | Pfizer, Inc. | 2021-02-24 |
| ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L (P010012/S532) | Boston Scientific Corp | 2021-02-24 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P180046/S029) | Boston Scientific Corporation | 2021-02-24 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S006) | Boston Scientific Corporation | 2021-02-24 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S482) | Medtronic Neuromodulation | 2021-02-24 |
| Deep Brain Stimulation (DBS) System (P140009/S065) | ABBOTT MEDICAL | 2021-02-24 |
| VisuMax Femtosecond Laser (P150040/S009) | Carl Zeiss Meditec, Inc. | 2021-02-24 |
| prodisc C (P070001/S020) | Centinel Spine, LLC | 2021-02-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck (P190034) | Roche Diagnostics | 2021-02-23 |
| Integrity Coronary Stent System (P030009/S099) | Medtronic, Ireland | 2021-02-23 |
| Cerene Cryotherapy Device (P180032/S004) | Channel Medsystems, Inc. | 2021-02-23 |
| Axonics Sacral Neuromodulation (SNM) System for Urinary Control (P190006/S029) | Boston Scientific Corporation | 2021-02-23 |
| Resolute Integrity RX Zotarolimus-Eluting Coronary Stent System (P110013/S107) | Medtronic Vascular | 2021-02-23 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S043) | Medtronic Vascular | 2021-02-23 |
| PD-L1 IHC 22C3 pharmDx (P150013/S021) | Agilent Technologies, Inc. | 2021-02-22 |
| VNS Therapy System (P970003/S234) | LivaNova USA, Inc. | 2021-02-22 |
| Straumann Emdogain (P930021/S027) | The Straumann Company | 2021-02-22 |
| Internal Leads Extensions and 8 Chanel Adapters (P140009/S053) | ABBOTT MEDICAL | 2021-02-22 |
| Paddle Leads (P010032/S157) | ABBOTT MEDICAL | 2021-02-22 |
| MitraClip Clip System (P100009/S038) | ABBOTT MEDICAL | 2021-02-22 |
| SENSAR 1-Piece IOL with Smart LOAD Delivery Technology, TECNIS 1-Piece IOL with Smart LOAD Delivery Technology, TECNIS O (P980040/S130) | Johnson & Johnson Surgical Vision, Inc. | 2021-02-22 |
| VisuMax Femtosecond Laser (P150040/S008) | Carl Zeiss Meditec, Inc. | 2021-02-19 |
| Stellarex 035 OTW Drug-Coated Angiopiasty Balloon (DCB) (P160049/S011) | The Spectranetics Corp. | 2021-02-19 |
| RxSight Light Adjustable Lens and Light Delivery Device (P160055/S016) | Rxsight, Inc. | 2021-02-19 |
| LCS Total Knee System (P830055/S262) | Depuy, Inc. | 2021-02-19 |
| AcrySof ReSTOR Posterior Chamber Intraocular Lenses (P040020/S094) | Alcon Research, Ltd. | 2021-02-18 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S010) | Medtronic Vascular, Inc. | 2021-02-18 |
| WaveLlght EX500 Laser System (P020050/S037) | Alcon Laboratories, Inc. | 2021-02-18 |
| Micra TPS (P150033/S092) | Medtronic, Inc. | 2021-02-18 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S039) | Medtronic Vascular | 2021-02-18 |