| Misago RX Self-expanding Peripheral Stent (P140002/S020) | Terumo Medical Corporation | 2019-12-05 |
| Innova Vascular Self-Expanding Stent System (P140028/S049) | Boston Scientific Corporation | 2019-12-04 |
| Innova Self-Expanding Stent System (P140028/S047) | Boston Scientific Corporation | 2019-12-04 |
| Natrelle Saline-Filled Breast Implants (P990074/S043) | Allergan | 2019-12-04 |
| Nucleus ABI541 Auditory Brainstem Implant (P000015/S038) | Cochlear Americas | 2019-12-04 |
| Origen Mini ICD VR, Origen Mini ICD DR, Inogen Mini ICD VR, Inogen Mini ICD DR, Dynagen Mini ICD VR, Dynagen Mini ICD DR (P960040/S445) | Boston Scientific | 2019-12-04 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S017) | Boston Scientific Corp | 2019-12-04 |
| Platinium 4LV CRT-D (P060027/S100) | MicroPort CRM USA, Inc. | 2019-12-04 |
| Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG and Azure S DR/SR MRI IPG, Azure XT DR/SR MRI IPG (P980035/S607) | Medtronic, Inc. | 2019-12-04 |
| Gynecare Interceed Absorbable Adhesion Barrier (P880047/S033) | ETHICON, Inc. | 2019-12-04 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S018) | Boston Scientific Corp | 2019-12-04 |
| Essentio SR, Essentio DR, Essentio EL DR, Proponent SR, Proponent DR, Proponent EL DR, Accolade SR, Accolade DR, Accola (N970003/S246) | Boston Scientific Corp | 2019-12-04 |
| Valitude CRT-P, Valitude X4 CRT-P, Visionist CRT-P, and Visionist X4 CRT-P (P030005/S192) | Guidant Corp. | 2019-12-04 |
| iSert Preloaded System, iSpheric, iSymm IOL Models, Clarisert Preloaded System (P080004/S027) | Hoya Surgical Optics, Inc. | 2019-12-04 |
| Hybrid L24 CI System (P130016/S038) | Cochlear Americas | 2019-12-04 |
| INFUSE Bone Graft (P050053/S049) | Medtronic, Inc. | 2019-12-04 |
| Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S027) | Boston Scientific Corp | 2019-12-04 |
| AMS 800 Series Product Line/Artificial Urinary sphincter with and without InhibiZone Treatment (P000053/S109) | Boston Scientific Corp | 2019-12-04 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S019) | Boston Scientific Corp | 2019-12-04 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S009) | Biotronik AG | 2019-12-04 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S056) | Boston Scientific Corporation | 2019-12-04 |
| INFUSE Bone Graft (P000054/S058) | Medtronic Sofamor Danek USA, Inc. | 2019-12-04 |
| Innova Vascular Self-Expanding Stent System (P140028/S048) | Boston Scientific Corporation | 2019-12-04 |
| Biocor, Biocor Supra, Epic and Epic Supra Heart Valves (P040021/S042) | ABBOTT MEDICAL | 2019-12-04 |
| Origen CRT-D, Origen X4 CRT-D, Momentum, Momentum CRT-D, Momentum X4 CRT-D, Inogen CRT-D, Inogen X4 CRT-D, Dynagen CRT-D (P010012/S513) | Boston Scientific Corp | 2019-12-04 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S005) | Biotronik AG | 2019-12-04 |
| CapSureFix MRI Lead (P090013/S302) | Medtronic, Inc. | 2019-12-04 |
| LCS Total Knee System (P830055/S240) | Depuy, Inc. | 2019-12-04 |
| Nucleus 24 Cochlear Implant System (P970051/S187) | Cochlear Americas | 2019-12-04 |
| CapSureFix Novus; Vitatron Crystalline Active Fixation Lead (P930039/S205) | Medtronic, Inc. | 2019-12-04 |
| Astron Pulsar Stent System and Pulsar-18 Stent System (P160025/S009) | Biotronik AG | 2019-12-04 |
| iSymm, iSpheric IOL (P080004/S026) | Hoya Surgical Optics, Inc. | 2019-12-04 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S011) | Biotronik AG | 2019-12-04 |
| Promus PREMIER/ Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S173) | Boston Scientific Corp | 2019-12-04 |
| Sprint Quattro Lead (P920015/S237) | Medtronic, Inc. | 2019-12-04 |
| Essentio MRI SR, Essentio MRI DR, Essentio MRI EL DR, Proponent, Accolade MRI SR, Accolade MRI DR and Accolade MRI EL DR (P150012/S087) | Boston Scientific | 2019-12-04 |
| Trifecta and Trifecta GT Heart Valves (P100029/S042) | ABBOTT MEDICAL | 2019-12-04 |
| INFUSE Bone Graft/Medtronic Interbody Fusion Device (P000058/S077) | Medtronic Sofamor Danek USA, Inc. | 2019-12-04 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S170) | Boston Scientific Corp | 2019-12-04 |
| CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead (P830061/S177) | Medtronic Cardiac Rhythm Disease Management | 2019-12-03 |
| ARCHITECT AUSAB, LN 1L82 (P050051/S036) | Abbott Laboratories, Inc. | 2019-12-03 |
| FoundationOne CDx (P170019/S006) | Foundation Medicine, Inc. | 2019-12-03 |
| CapSureFix MRI Lead (P090013/S303) | Medtronic, Inc. | 2019-12-03 |
| Attain StarFix Lead (P060039/S098) | Medtronic, Inc. | 2019-12-03 |
| Myocardial Pacing Lead (P120017/S020) | Medtronic, Inc. | 2019-12-03 |
| Juvederm Injectable Gel Implants (P110033/S051) | Allergan | 2019-12-03 |
| HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead and Transvene CS/SVC L (P920015/S239) | Medtronic, Inc. | 2019-12-03 |
| Attain Ability Lead, Attain Performa Lead and Attain Stability Quad MRI Lead (P080006/S143) | Medtronic, Inc. | 2019-12-03 |
| SelectSecure Lead (P030036/S115) | Medtronic Cardiac Rhythm Disease Management | 2019-12-03 |
| LCS(R) Total Knee System (P830055/S241) | Depuy, Inc. | 2019-12-03 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S VR/DR/ICD, Evera XT DR/VR/ ICD, Mirror MRI DR/VR ICD, Primo MRI DR/VR ICD, Pr (P980016/S724) | Medtronic Cardiac Rhythm Disease Management | 2019-12-03 |
| LCS Total Knee System (P830055/S238) | Depuy, Inc. | 2019-12-03 |
| Surgicel Absorbable Hemostats (N12159/S067) | ETHICON, Inc. | 2019-12-03 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Attesta DR/SR (P980035/S609) | Medtronic, Inc. | 2019-12-03 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSUre SP Novus Lead and Vitatron Impulse II Lead (P850089/S145) | Medtronic Cardiac Rhythm Disease Management | 2019-12-03 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena (P010015/S422) | Medtronic, Inc. | 2019-12-03 |
| Biomet OrthoPak Non-invasive Bone Growth Stimulator System and Biomet SpinalPak Non-invasive Spine Fusion Stimulator Sys (P850022/S030) | Ahp Eos Buyer, Inc. | 2019-12-03 |
| Transvene CS/SVC Lead (P980050/S124) | Medtronic, Inc. | 2019-12-03 |
| Epicardial Patch Lead (P900061/S156) | Medtronic Cardiac Rhythm Disease Management | 2019-12-03 |
| CapSure VDD-2 Lead, CareLink SmartSync Device manager Programmer and Vitatron Brilliant S+ VDD Lead (P890003/S422) | Medtronic, Inc. | 2019-12-03 |
| Gore Viabahn VBX Balloon Expandable Endoprosthesis (P160021/S023) | W. L. Gore & Associates, Inc. | 2019-12-03 |
| Juvederm Injectable Gel Implants (P050047/S074) | Allergan | 2019-12-03 |
| Amplia MRI CRT-D, Amplia/Claria/Compia MRI QUAD CRT-D, Brava CRT-D, Brava Quad CRT-D, Compia MRI CRT-D,Consulta/Protecta (P010031/S685) | Medtronic Cardiac Rhythm Disease Management | 2019-12-03 |
| CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S207) | Medtronic, Inc. | 2019-12-03 |
| CapSure Epicardial Pacing Lead (P950024/S090) | Medtronic, Inc. | 2019-12-03 |
| Micra TPS (P150033/S063) | Medtronic, Inc. | 2019-12-03 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S033) | Pfizer, Inc. | 2019-12-03 |
| MarginProbe System (P110014/S010) | Dilon Medical Technologies, Ltd. | 2019-12-02 |
| Superion Indirect Decompression System (P140004/S016) | Boston Scientific Neuromodulation | 2019-12-02 |
| VICI VENOUS STENT System (P180013/S003) | Boston Scientific Corporation | 2019-12-02 |
| Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S076) | Medtronic Sofamor Danek USA, Inc. | 2019-11-29 |
| Infuse Bone Graft (P000054/S057) | Medtronic Sofamor Danek USA, Inc. | 2019-11-29 |
| iSert Preloaded System/ iSert Micro Injector (P080004/S025) | Hoya Surgical Optics, Inc. | 2019-11-29 |
| CERAMAX Ceramic Total Hip System (P070026/S059) | DePuy Orthopaedics, Inc. | 2019-11-29 |
| Hintermann Series H3 Total Ankle Replacement System (P160036/S001) | Dt Medtech, LLC | 2019-11-29 |
| INFUSE BONE GRAFT (P050053/S048) | Medtronic, Inc. | 2019-11-29 |
| Impella 5.5 with SmartAssist (P140003/S064) | Abiomed, Inc. | 2019-11-28 |
| CapSure Sense Lead (P830061/S178) | Medtronic Cardiac Rhythm Disease Management | 2019-11-27 |
| AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S168) | Boston Scientific Corp | 2019-11-27 |
| Lotrafilcon A and B Soft Contact Lenses for Extended Wear (P010019/S072) | Alcon Laboratories, Inc. | 2019-11-27 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S169) | Boston Scientific Corp | 2019-11-27 |
| Valitude CRT-P IS1/IS4 EL, Visionist CRT-P IS1 El and Visionist CRT-P LV1 EL (P030005/S191) | Guidant Corp. | 2019-11-27 |
| AMS 800 Series Product Line/ Artificial Urinary Sphincter with and without InhibiZone Treatment (P000053/S108) | Boston Scientific Corp | 2019-11-27 |
| CapSureFix MRI Lead (P090013/S304) | Medtronic, Inc. | 2019-11-27 |
| CapSureFix Novus Lead (P930039/S208) | Medtronic, Inc. | 2019-11-27 |
| Essentio SR/DR SL, Essentio DR EL, Proponent SR/DR SL, Proponent DR EL, Accolade SR/DR SL, Accolade DR EL, Altrua 2 SR/D (N970003/S245) | Boston Scientific Corp | 2019-11-27 |
| Essentio MRI SR/DR SL, Essentio MRI DR EL, Proponent MRI SR/DR SL, Proponent MRI DR EL, Accolade MRI SR/DR SL and Accola (P150012/S086) | Boston Scientific | 2019-11-27 |
| PROMUS PREMIER Everolimus-Eluting Chromium Coronary Stent System (Monorail and Over The Wire) and PROMUS ELITE Everolimu (P110010/S172) | Boston Scientific Corp | 2019-11-26 |
| REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P130030/S063) | Boston Scientific Corp | 2019-11-26 |
| Carpentier-Edwards Perimount Aortic Bioprostheses and Carpentier-Edwards Perimount Mitral Bioprostheses (P860057/S195) | Edwards Lifesciences, LLC | 2019-11-26 |
| LATITUDE Programming System (P910077/S175) | Boston Scientific | 2019-11-26 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S074) | Syncardia Systems, LLC | 2019-11-26 |
| LUTONIX 035 Drug Coated Balloon PTA Catheter, Model 9010 (P170003/S014) | Lutonix | 2019-11-26 |
| Cartiva Synthetic Cartilage Implant (P150017/S014) | Cartiva, Inc. | 2019-11-26 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P150003/S057) | Boston Scientific Corporation | 2019-11-26 |
| SURGICEL Absorbable Hemostats (N12159/S052) | ETHICON, Inc. | 2019-11-26 |
| LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software (P180047) | DiaSorin, Inc. | 2019-11-26 |
| HeartStart OnSite Defibrillator and HeartStart Home Defibrillator (P160029/S002) | Philips Medical Systems, Inc. | 2019-11-26 |
| Edwards Pericardial Aortic Bioprostheses and Edwards Inspiris Resilia Aortic Valve (P150048/S042) | Edwards Lifesciences, LLC | 2019-11-26 |
| InterStim Therapy System and Verify Evaluation System (P080025/S194) | Medtronic Neuromodulation | 2019-11-26 |