| Model 2889 EMBLEM S-ICD Automated Screening Tool, v1.01 (P110042/S067) | Boston Scientific Corporation | 2017-07-06 |
| Auditory Brainstem Implant (P000015/S022) | Cochlear Americas | 2017-07-06 |
| Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System (P060037/S049) | Zimmer, Inc. | 2017-07-06 |
| Gynecare Interceed Absorbable Adhesion Barrier (P880047/S027) | ETHICON, Inc. | 2017-07-06 |
| Nucleus 24 Cochlear Implant System (P970051/S165) | Cochlear Americas | 2017-07-06 |
| TRIDYNE VASCULAR SEALANT (P150016/S005) | Neomend, Inc. | 2017-07-06 |
| Nucleus 24 Hybrid System (P130016/S029) | Cochlear Americas | 2017-07-06 |
| Surgicel Absorbable Hemostat (N12159/S044) | ETHICON, Inc. | 2017-07-06 |
| MULTIPLE APPLICATION UTILITY MODEL 2909 (FROM V9.03 TO V9.04) (P910077/S155) | Boston Scientific | 2017-07-06 |
| Restylane Refyne and Restylane Defyne (P140029/S003) | Q-Med AB | 2017-07-06 |
| Life Pulse High Frequency Ventilator (P850064/S034) | Bunnell, Inc. | 2017-07-06 |
| Heparin_Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System (P940016/S023) | B. Braun Avitum AG | 2017-07-06 |
| Micra Transcatheter Pacing System (P150033/S024) | Medtronic, Inc. | 2017-07-05 |
| Codman 3000 and Medstream Implantable Infusion Pumps (P890055/S068) | Intera Oncology | 2017-07-05 |
| CapSure Epicardial Pacing Lead (P950024/S074) | Medtronic, Inc. | 2017-07-05 |
| Subcutaneous Lead, Transvene CS/SVC Lead (P920015/S200) | Medtronic, Inc. | 2017-07-05 |
| CapSure SP/Z Novus Lead, Vitatron Excellence SS+/Impulse II Lead (P850089/S126) | Medtronic Cardiac Rhythm Disease Management | 2017-07-05 |
| NATRELLE Highly Cohesive Anatomically Shaped Silicone-Filled (P040046/S023) | Allergan | 2017-07-05 |
| CapSure VDD 2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S376) | Medtronic, Inc. | 2017-07-05 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S148) | Medtronic Cardiac Rhythm Disease Management | 2017-07-05 |
| Avitene® Microfibrillar Collagen Hemostat (P800002/S022) | C.R. Bard, Inc. | 2017-07-05 |
| Attain Ability/Performa Lead (P080006/S112) | Medtronic, Inc. | 2017-07-05 |
| Myocardial Pacing Lead (P120017/S009) | Medtronic, Inc. | 2017-07-05 |
| Codman Trufill N-Butyl Cyanoacrylate Liquid Embolic System (P990040/S025) | Cerenovus, Inc. | 2017-07-05 |
| NATRELLE-Saline-Filled Breast Implants (P990074/S039) | Allergan | 2017-07-05 |
| Rotational Atherectomy System (P900056/S157) | Boston Scientific Corp | 2017-07-05 |
| IN PACT Admiral Paclitarel-Coated Balloon Catheter (P140010/S032) | Medtronic, Inc. | 2017-07-05 |
| Transvene CS/SVC Lead (P980050/S112) | Medtronic, Inc. | 2017-07-05 |
| Model 400 Implantable Infusion Pump (P800036/S040) | Intera Oncology | 2017-07-05 |
| NATRELLE Silicone-Filled Breast Implants (P020056/S042) | Allergan | 2017-07-05 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation/Pirouet Lead (P930039/S174) | Medtronic, Inc. | 2017-07-05 |
| Axium Leads and other accessories (P150004/S005) | ABBOTT MEDICAL | 2017-07-03 |
| Wallstent (Venous) Endoprosthesis with unistep plus delivery system (P980033/S049) | Boston Scientific Corporation | 2017-07-03 |
| Wallstent Illiac Endoprosthesis with unistep plus delivery system (P940019/S051) | Boston Scientific Scimed, Inc. | 2017-07-03 |
| Carotid Wallstent Monorail Endoprothesis plus delivery system (P050019/S028) | Boston Scientific Corp | 2017-07-03 |
| Wallstent (Tips) Endoprosthesis with unistep plus delivery system (P930031/S060) | Boston Scientific Corp | 2017-07-03 |
| EASYTRACK 2 Lead, ACUITY Spiral Lead (P010012/S456) | Boston Scientific Corp | 2017-06-30 |
| Hanock II Bioprosthesis, Models T505 and T510 (P980043/S059) | Medtronic, Inc. | 2017-06-30 |
| Mosaic Bioprosthesis, Models 305 and 310 (P990064/S068) | Medtronic, Inc. | 2017-06-30 |
| FINELINE II Lead (P960040/S397) | Boston Scientific | 2017-06-30 |
| ENDOTAK RELIANCE IS-1 LEAD (P910073/S143) | Boston Scientific | 2017-06-30 |
| Air Optix Night & Day Aqua (P010019/S055) | Alcon Laboratories, Inc. | 2017-06-30 |
| HEARTMATE II LVAS (P060040/S065) | ABBOTT MEDICAL | 2017-06-30 |
| Cologuard (P130017/S018) | Exact Sciences Corporation | 2017-06-30 |
| STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System (P930016/S048) | Amo Manufacturing USA, LLC | 2017-06-30 |
| OraQuick HCV Antibody Test (P080027/S028) | OraSure Technologies, Inc. | 2017-06-30 |
| Virtuso/Entrust/Maximo/Intrinsic/Marquis/Implantable Cardiverter Defibrillators (P980016/S635) | Medtronic Cardiac Rhythm Disease Management | 2017-06-30 |
| Concerto/Insync Sentry/Insync Maximo Implantable Cardiovascular Defibrillators with Cardiac Resynchicnization (P010031/S596) | Medtronic Cardiac Rhythm Disease Management | 2017-06-30 |
| SEPRAFILM ADHESION BARRIER (P950034/S047) | Baxter Healthcare Corporation | 2017-06-29 |
| EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500) (P150048) | Edwards Lifesciences, LLC | 2017-06-29 |
| Minimed 630G System with Smartguard (P150001/S017) | Medtronic Minimed | 2017-06-29 |
| HeartWare Ventricular Assist Device System (P100047/S100) | Medtronic | 2017-06-29 |
| Prometra Programmable Infusion Pump System (P080012/S044) | Infusyn Therapeutics, LLC | 2017-06-29 |
| Genesys Hta 115V Control Unit, Genesys Hta 115V Control Unit (Demo), Genesys Hta 115V Control Unit (Refurb), Genesys Hta (P000040/S035) | Axora Medical, Inc. | 2017-06-29 |
| Praxis Extended RAS Panel (P160038) | Illumina, Inc. | 2017-06-29 |
| MiniMed 670G System (P160017/S014) | Medtronic Minimed, Inc. | 2017-06-29 |
| Trim Change (P010032/S129) | ABBOTT MEDICAL | 2017-06-28 |
| Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (P810025/S037) | Bausch & Lomb, Inc. | 2017-06-28 |
| PROPEL Contour Sinus Implant Delivery System (P100044/S029) | Intersect Ent. | 2017-06-28 |
| Wallstent (Venous) Endoprosthesis With Unistep Plus Delivery System (P980033/S048) | Boston Scientific Corporation | 2017-06-28 |
| NEVISENSE (P150046) | Scibase AB | 2017-06-28 |
| MYNXGRIP VASCULAR CLOSURE DEVICE (P040044/S075) | Cordis US Corporation | 2017-06-28 |
| CapSureFix MRI Lead 5086MRI (P090013/S258) | Medtronic, Inc. | 2017-06-28 |
| Wallstent (Tips) Endoprosthesis With Unistep Plus Delivery System (P930031/S059) | Boston Scientific Corp | 2017-06-28 |
| Axium Neurostimulator System (P150004/S010) | ABBOTT MEDICAL | 2017-06-28 |
| OcuCoat OVD (P860047/S032) | Bausch & Lomb, Inc. | 2017-06-28 |
| ASTRA S DR MRI IPG X3DR01, ASTRA S SR MRI IPG X3SR01, ASTRA XT DR MRI IPG X1DR01, ASTRA XT SR MRI IPG X1SR01 (P980035/S509) | Medtronic, Inc. | 2017-06-28 |
| BRIO NEUROSTIMULATION SYSTEM (P140009/S024) | ABBOTT MEDICAL | 2017-06-28 |
| EnVeo R Delivery Catheter System (P130021/S038) | Medtronic, Inc. | 2017-06-28 |
| Percepta Bipolar CRT-P W1TR01, Percepta Quadripolar CRT-P W4TR01, Serena Bipolar CRT-P W1TR02, Serena Quadripolar CRT-P (P010015/S334) | Medtronic, Inc. | 2017-06-28 |
| CapSureFix Novus Lead 4076, 5076 - Vitatron Crystalline Active Fixation Lead ICF09, ICF09B, ICFQ09B (P930039/S171) | Medtronic, Inc. | 2017-06-28 |
| Wallstent Lilac Endoprosthesis With Unistep Plus Delivery System (P940019/S050) | Boston Scientific Scimed, Inc. | 2017-06-28 |
| ReShape Integrated Dual Ballon System (P140012/S010) | Boston Scientific Corporation | 2017-06-27 |
| HeartWare Ventricular Assist System (P100047/S095) | Medtronic | 2017-06-27 |
| IntellaNav XP and IntellaNav MiFi XP Temperature Ablation Catheters (P020025/S102) | Boston Scientific | 2017-06-27 |
| COAPTITE Injectabl Implant (P040047/S045) | Merz North America, Inc. | 2017-06-27 |
| VITROS Immunodiagnostic Products HBsAg Reagent Pack; VITROS Immunodiagnostic Products HBsAg Calibrator (P000044/S035) | Ortho-Clinical Diagnostics, Inc. | 2017-06-27 |
| CELT ACD VASCULAR CLOSURE DEVICE (P150006/S001) | Vasorum, Ltd. | 2017-06-27 |
| IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT (P120011/S006) | Bimini Health Tech | 2017-06-27 |
| RADIESSE (+) Lidocaine Derma Filler (P050052/S094) | Merz North America, Inc. | 2017-06-27 |
| RADIESSE Injectable Implant (P050037/S080) | Merz North America, Inc. | 2017-06-27 |
| HeartWare Ventricular Assist Device System (P100047/S097) | Medtronic | 2017-06-27 |
| HeartWare Ventricular Assist System (P100047/S098) | Medtronic | 2017-06-27 |
| Minerva Endometrial Ablation System (P140013/S007) | Axora Medical, Inc. | 2017-06-26 |
| Contak CD,Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill (P010012/S455) | Boston Scientific Corp | 2017-06-26 |
| Radiesse Injectable Implant (P050037/S081) | Merz North America, Inc. | 2017-06-26 |
| ExAblate (P150038/S003) | Insightec | 2017-06-26 |
| Radiesse (+) Lidocaine Injectable Implant (P050052/S095) | Merz North America, Inc. | 2017-06-26 |
| XIENCE PRIME SV/LL Everolimus Eluting Coronary Stent System (P110019/S093) | Abbott Vascular | 2017-06-23 |
| Absorb GTi Bioresorbable Vascular Scaffold (BVS) System (P150023/S009) | Abbott Vascular, Inc. | 2017-06-23 |
| MiniMed 530G System (P120010/S104) | Medtronic, Inc. | 2017-06-23 |
| RF Filter Module (P020025/S095) | Boston Scientific | 2017-06-23 |
| Elecsys HBsAg II (100/200 tests) Immunoassay (P160019/S002) | Roche Diagnostics, Inc. | 2017-06-23 |
| Elecsys Anti-HBc IgM Immunoassay (P110025/S019) | Roche Diagnostics Corp. | 2017-06-23 |
| VNS THERAPY SYSTEM (P970003/S207) | LivaNova USA, Inc. | 2017-06-23 |
| XIENCE V/nano Everolimus Eluting Coronary Stent System (P070015/S137) | Abbott Vascular, Inc. | 2017-06-23 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S059) | ABBOTT MEDICAL | 2017-06-23 |
| Elecsys free PSA Immunoassay (P000027/S025) | Roche Diagnostics Corp. | 2017-06-23 |
| Elecsys total PSA (100/200 tests) Immunoassay (P990056/S026) | Roche Diagnostics Corp. | 2017-06-23 |
| COHERA MEDICAL TISSUEGLU SURGICAL ADHESIVE (P130023/S002) | Cohera Medical, Inc. | 2017-06-23 |