| TactiCath Quartz Contact Force Ablation Catheter (P130026/S058) | St Jude Medical | 2020-06-05 |
| Infinity Family of DBS IPGs (P140009/S052) | ABBOTT MEDICAL | 2020-06-05 |
| Alinity i AFP Reagent Kit (P120008/S013) | Abbott Laboratories | 2020-06-05 |
| Alinity i Anti-HBs Reagent Kit (P050051/S037) | Abbott Laboratories, Inc. | 2020-06-05 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S056) | Coloplast Corp. | 2020-06-05 |
| FlexAbility and FlexAbility SE Ablation Catheter, FlexAbility Cables Sensor Enabled (P110016/S069) | ABBOTT MEDICAL | 2020-06-04 |
| Amplatzer Septal Occluder, Amplatzer Multi-Fenestrated Septal Occluder (P000039/S073) | ABBOTT MEDICAL | 2020-06-04 |
| Blazer Prime XP cardiac ablation catheters (P920047/S123) | Boston Scientific Corp | 2020-06-04 |
| Dorsal Root Ganglion (DRG) Stimulation (P150004/S039) | ABBOTT MEDICAL | 2020-06-04 |
| Amplatzer Muscular VSD Occluder (P040040/S043) | ABBOTT MEDICAL | 2020-06-04 |
| Durata HV Leads (P950022/S132) | ABBOTT MEDICAL | 2020-06-04 |
| Amplatzer PFO Occluder (P120021/S018) | ABBOTT MEDICAL | 2020-06-04 |
| Deep Brain Stimulation (DBS) (P140009/S060) | ABBOTT MEDICAL | 2020-06-04 |
| Blazer Prime HTD cardiac ablation catheter (P020025/S127) | Boston Scientific | 2020-06-04 |
| ENROUTE Transcarotid Stent System (P140026/S014) | Boston Scientific Corporation | 2020-06-04 |
| IntellaNav MiFi Open-Irrigated (OI) and IntellaTip MiFi OI ablation catheters (P150005/S056) | Boston Scientific Corp | 2020-06-04 |
| Lifeline/ReviveR, Lifeline/ReviveR AUTO, Lifeline/ReviveR VIEW, Lifeline/ReviveR VIEW AUTO, Lifeline/ReviveR ECG, and Li (P160032/S006) | Defibtech, LLC | 2020-06-04 |
| Livewire TC Ablation Catheter, Livewire TC Cables, Safire Ablation Catheter, Safire Cables (P960016/S083) | St Jude Medical | 2020-06-04 |
| Spinal Cord Stimulation (SCS) (P010032/S164) | ABBOTT MEDICAL | 2020-06-04 |
| Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder (P020024/S064) | ABBOTT MEDICAL | 2020-06-04 |
| TactiCath Quartz Contact Force Ablation Catheter, TactiCath Contact Force Ablation Catheter Sensor Enabled (P130026/S061) | St Jude Medical | 2020-06-04 |
| HeartWare Ventricular Assist System (P100047/S162) | Medtronic | 2020-06-03 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S076) | W. L. Gore & Associates, Inc. | 2020-06-03 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S137) | W. L. Gore & Associates, Inc. | 2020-06-03 |
| Axonics Sacral Neuromodulation System (P190006/S006) | Boston Scientific Corporation | 2020-06-02 |
| Bulkamid Urethral Bulking System (P170023/S001) | Boston Scientific Corporation | 2020-06-02 |
| Micra AV Transcatheter Pacing System (P150033/S073) | Medtronic, Inc. | 2020-06-02 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S429) | Medtronic, Inc. | 2020-06-02 |
| CapSureFix Lead (P930039/S211) | Medtronic, Inc. | 2020-06-02 |
| Myocardial Pacing Lead (P120017/S021) | Medtronic, Inc. | 2020-06-02 |
| CapSure Sense Lead, CapSure SP Novus Lead (P830061/S181) | Medtronic Cardiac Rhythm Disease Management | 2020-06-02 |
| Axonics Sacral Neuromodulation System (P180046/S006) | Boston Scientific Corporation | 2020-06-02 |
| Y Adapter/Extender Kit, IS-1 Connector Port Pin Plug Kit, Lead Adapter, Sprint Quattro Lead, Subcutaneous Lead, Transven (P920015/S243) | Medtronic, Inc. | 2020-06-02 |
| SelectSecure Lead (P030036/S119) | Medtronic Cardiac Rhythm Disease Management | 2020-06-02 |
| Floseal Hemostatic Matrix (P990009/S060) | Baxter Healthcare Corp | 2020-06-02 |
| Epicardial Patch Lead (P900061/S158) | Medtronic Cardiac Rhythm Disease Management | 2020-06-02 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S147) | Medtronic Cardiac Rhythm Disease Management | 2020-06-02 |
| CapSure Epicardial Pacing Lead (P950024/S092) | Medtronic, Inc. | 2020-06-02 |
| Transvene CS/SVC Lead (P980050/S126) | Medtronic, Inc. | 2020-06-02 |
| Integrity RX Coronary Stent System and Integrity OTW Coronary Stent System (P030009/S096) | Medtronic, Ireland | 2020-06-02 |
| iStent inject Trabecular Micro-Bypass System (P170043/S003) | Glaukos Corporation | 2020-06-01 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S107) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2020-06-01 |
| VISTAKON (senofilcon A)Brand Contact Lenses (P040045/S114) | Vistakon, Division of Johnson & Johnson Vision Car | 2020-06-01 |
| ENROUTE Transcarotid Stent System (P140026/S015) | Boston Scientific Corporation | 2020-06-01 |
| Deep Brain Stimulation Therapy (P140009/S059) | ABBOTT MEDICAL | 2020-05-30 |
| Dorsal Root Ganglion Stimulator for Pain Relief (P150004/S038) | ABBOTT MEDICAL | 2020-05-30 |
| Totally Implanted Spinal Cord Stimulator for Pain Relief (P010032/S163) | ABBOTT MEDICAL | 2020-05-30 |
| Cordis S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System (P120002/S017) | Cordis US Corporation | 2020-05-29 |
| Bard Fluency Plus Endovascular Stent Graft (P130029/S008) | Bard Peripheral Vascular, Inc. | 2020-05-29 |
| Cordis S.M.A.R.T. CONTROL Nitinol Stent System (P020036/S042) | Cordis US Corporation | 2020-05-29 |
| PSW 1904.U (P050023/S145) | Biotronik, Inc. | 2020-05-29 |
| IntellaNav MiFi Open-Irrigated Ablation Catheter (P150005/S054) | Boston Scientific Corp | 2020-05-29 |
| Bard E-Luminexx Vascular Stent (P080007/S023) | Bard Peripheral Vascular, Inc. | 2020-05-29 |
| PSW 1904.U (P070008/S115) | Biotronik, Inc. | 2020-05-29 |
| PSW 1904.U (P950037/S211) | Biotronik, Inc. | 2020-05-29 |
| PSW 1904.U (P000009/S084) | Biotronik, Inc. | 2020-05-29 |
| Cordis PRECISE Nitinol Stent System (P030047/S040) | Cordis US Corporation | 2020-05-29 |
| PSW 1904.U (P980023/S100) | Biotronik, Inc. | 2020-05-29 |
| IntellaNav OI, and IntellaNav MiFi OI (P150005/S055) | Boston Scientific Corp | 2020-05-28 |
| SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) (P150003/S055) | Boston Scientific Corporation | 2020-05-28 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S032) | Medtronic Vascular | 2020-05-28 |
| TECNIS Symfony OptiBlue IOL, TECNIS Symfomy Toric II OptiBlue IOLs (P980040/S112) | Johnson & Johnson Surgical Vision, Inc. | 2020-05-28 |
| HiResolution Bionic Ear System (P960058/S148) | Advanced Bionics | 2020-05-28 |
| Evolut R, Evolut PRO and Evolut PRO+ Systems (P130021/S072) | Medtronic, Inc. | 2020-05-28 |
| EMBLEM Subcutaneous Implantable Cardioverter-Defibrillator (S-ICD) (P110042/S138) | Boston Scientific Corporation | 2020-05-28 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S060) | St Jude Medical | 2020-05-28 |
| Juvéderm Injectable Gel Implants (P050047/S076) | Allergan | 2020-05-28 |
| Acess AFP Reagents on the Access Immunoassay Systems (P980041/S043) | Beckman Coulter, Inc. | 2020-05-28 |
| VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM (P150031/S035) | Boston Scientific Corp | 2020-05-27 |
| Precision Spinal Cord Stimulator(SCS) Systems (P030017/S339) | Boston Scientific Corp | 2020-05-27 |
| Cobalt XT DR MRI SureScan, Cobalt DR MRI SureScan, Crome DR MRI SureScan, Cobalt XT VR MRI SureScan, Cobalt VR MRI SureS (P980016/S740) | Medtronic Cardiac Rhythm Disease Management | 2020-05-27 |
| Cobalt XT HF Quad CRT-D MRI SureScan, Cobalt XT HF CRT-D MRI SureScan, Cobalt HF Quad CRT-D MRI SureScan, Cobalt HF CRT- (P010031/S701) | Medtronic Cardiac Rhythm Disease Management | 2020-05-27 |
| Juvederm Injectable Gel Implants (P110033/S054) | Allergan | 2020-05-27 |
| Juvederm Injectable Gel Implants (P050047/S075) | Allergan | 2020-05-27 |
| BreathTek UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA) (P100025/S014) | Meridian Bioscience, Inc. | 2020-05-26 |
| Oncomine Dx Target Test (P160045/S020) | Life Technologies Corporation | 2020-05-26 |
| SJM Masters Valved Graft with Hemashield graft technology (P810002/S112) | ABBOTT MEDICAL | 2020-05-26 |
| 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/S626) | Medtronic, Inc. | 2020-05-26 |
| MANTA Vascular Closure Device (P180025/S007) | Teleflex Medical, LLC | 2020-05-26 |
| VICI VENOUS STENT System (P180013/S005) | Boston Scientific Corporation | 2020-05-26 |
| C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens, and RayOne Aspheric (P060011/S021) | Rayner Intraocular Lenses , Ltd. | 2020-05-26 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S033) | Nevro Corporation | 2020-05-26 |
| PRISMAFLEX TPE 2000 Set (P830063/S016) | Vantive US Healthcare, LLC | 2020-05-23 |
| Alinity i Anti-HBc lgM (P060035/S029) | Abbott Laboratories | 2020-05-23 |
| ARCHITECT Anti-HCV (P050042/S042) | Abbott Laboratories, Inc. | 2020-05-23 |
| AMPLATZER PFO Occluder (P120021/S017) | ABBOTT MEDICAL | 2020-05-23 |
| ARCHITECT CORE-M (P060035/S030) | Abbott Laboratories | 2020-05-23 |
| Alinity i Anti-HBc (P080023/S032) | Abbott Laboratories | 2020-05-23 |
| Alinity i Anti-HCV (P050042/S041) | Abbott Laboratories, Inc. | 2020-05-23 |
| ARCHITECT HBsAg Qualitative/Confirmatory (P110029/S032) | Abbott Laboratories | 2020-05-23 |
| AMPLATZER Duct Occluder Family (ADO, ADOII, Piccolo) (P020024/S063) | ABBOTT MEDICAL | 2020-05-23 |
| Alinity i Anti-HBs (P050051/S038) | Abbott Laboratories, Inc. | 2020-05-23 |
| ARCHITECT CORE (P080023/S033) | Abbott Laboratories | 2020-05-23 |
| ARCHITECT Free PSA (P980007/S042) | Abbott Laboratories | 2020-05-23 |
| ARCHITECT Total PSA (P910007/S053) | Abbott Laboratories | 2020-05-23 |
| ARCHITECT AFP (P120008/S015) | Abbott Laboratories | 2020-05-23 |
| AMPLATZER Septal Occluder, AMPLATZER Multi-Fenestrated Septal Occluder (P000039/S072) | ABBOTT MEDICAL | 2020-05-23 |
| Alinity i AFP (P120008/S014) | Abbott Laboratories | 2020-05-23 |
| AMPLATZER Muscular VSD Occluder (P040040/S042) | ABBOTT MEDICAL | 2020-05-23 |
| ARCHITECT AUSAB (P050051/S039) | Abbott Laboratories, Inc. | 2020-05-23 |