| Medstream Programmable Infusion System (P890055/S063) | Intera Oncology | 2016-08-18 |
| GORE VIATORR TIPS (P040027/S048) | W. L. Gore & Associates, Inc. | 2016-08-18 |
| Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Resume, Specify, and Vectris Spinal Cord Stimul (P840001/S336) | Medtronic Neuromodulation | 2016-08-18 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S130) | Boston Scientific Corp | 2016-08-18 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S086) | W. L. Gore & Associates, Inc. | 2016-08-18 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S078) | Medtronic | 2016-08-18 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047/S043) | Neomend, Inc. | 2016-08-17 |
| NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS (P040046/S016) | Allergan | 2016-08-17 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S006) | Boston Scientific Corporation | 2016-08-17 |
| OVATION ABDOMINAL STENT GRAFT SYSTEM PLATFORM (P120006/S025) | Endologix, LLC | 2016-08-17 |
| Amplia MRI CRT-D DTMB1D4; Amplia MRI Quad CRT-D DTMB1QQ; Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ (P010031/S558) | Medtronic Cardiac Rhythm Disease Management | 2016-08-16 |
| Revo MRI SureScan IPG RVDR01 (P090013/S232) | Medtronic, Inc. | 2016-08-16 |
| TECNIS TORIC CALCULATOR (P980040/S066) | Johnson & Johnson Surgical Vision, Inc. | 2016-08-16 |
| Micra TPS MC1VR01 (P150033/S005) | Medtronic, Inc. | 2016-08-16 |
| Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever (P980016/S597) | Medtronic Cardiac Rhythm Disease Management | 2016-08-16 |
| Adapta, Versa, Sensia IPG ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, A (P980035/S472) | Medtronic, Inc. | 2016-08-16 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S241) | Boston Scientific Corp | 2016-08-16 |
| Consulta CRT-P C4TR01; Syncra CRT-P C2TR01; Viva CRT-P C6TR01 (P010015/S306) | Medtronic, Inc. | 2016-08-16 |
| IPRO2 CGM SYSTEM WITH ENLITE SENSOR (P150029/S001) | Medtronic Minimed | 2016-08-15 |
| SELECTSECURE LEAD (P030036/S086) | Medtronic Cardiac Rhythm Disease Management | 2016-08-15 |
| MICRA TRANSCATHETER PACING SYSTEM (P150033/S006) | Medtronic, Inc. | 2016-08-15 |
| RESTYLANE / PERLANE INJECTABLE GEL (P040024/S091) | Q-Med AB | 2016-08-15 |
| PARADIGM REAL-TIME REVEL SYSTEM (P150019/S017) | Medtronic Minimed | 2016-08-15 |
| MINIMED 530G SYSTEM (P120010/S092) | Medtronic, Inc. | 2016-08-15 |
| G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM/DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S051) | Dexcom, Inc. | 2016-08-12 |
| VNS THERAPY ASPRICE HC AND ASPIRESR, DEMIPULSE AND DEMIPULSE DUO, PULSE AND PULSE DUO GENERATORS; VNS THERAPY PERENNIAD (P970003/S202) | LivaNova USA, Inc. | 2016-08-12 |
| EDWARDS INTUITY ELITE VALVE SYSTEM (P150036) | Edwards Lifesciences, LLC | 2016-08-12 |
| SOFLENS (POLYMACON) VISIBILITY TINTED CONTACT LENSES (N16895/S098) | Bausch & Lomb, Inc. | 2016-08-12 |
| ALGOVITA SPINAL CORD STIMULATION SYSTEM (P130028/S011) | Nuvectra Corporation | 2016-08-12 |
| VNS THERAPY SYSTEM (P970003/S203) | LivaNova USA, Inc. | 2016-08-12 |
| ACRYSOF INTRAOCULAR LENSES (P930014/S093) | Alcon Laboratories, Inc. | 2016-08-12 |
| Single-Piece Anterior Chamber IOL (P880087/S025) | Alcon Laboratories | 2016-08-11 |
| BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S090) | Boston Scientific | 2016-08-11 |
| THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER; THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL NAVIGATION CATHETE (P030031/S072) | Biosense Webster, Inc. | 2016-08-11 |
| Multi-Piece Posterior Chamber IOL (P810032/S066) | Alcon Laboratories | 2016-08-11 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S077) | Boston Scientific Corp | 2016-08-11 |
| INGEVITY ACTIVE FIXATION LEAD (P150012/S012) | Boston Scientific | 2016-08-11 |
| EXPRESS LD ILIAC OVER-THE-WIRE PREMOUNTED STENT SYSTEM (P090003/S042) | Boston Scientific Corporation | 2016-08-11 |
| BRYAN CERVICAL DISC SYSTEM (P060023/S005) | Companion Spine France Sas | 2016-08-11 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S094) | Boston Scientific Corp | 2016-08-11 |
| BLAZER OPEN-IRRIGATED TEMPERATURE ABLATION CATHETER (P150005/S009) | Boston Scientific Corp | 2016-08-11 |
| PRESTIGE CERVICAL DISC SYSTEM (P060018/S005) | Medtronic Sofamor Danek, Inc. | 2016-08-11 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S075) | Boston Scientific Corp | 2016-08-11 |
| CHILLI COOLED ABLATION CATHETER AND CABLE (P980003/S068) | Boston Scientific Corp | 2016-08-11 |
| ACRYSOF Posterior Chamber Intraocular Lens with UltraSert Preloaded Delivery System (P930014/S095) | Alcon Laboratories, Inc. | 2016-08-11 |
| Single-Piece Posterior Chamber IOL (P840060/S043) | Alcon Laboratories | 2016-08-11 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S036) | Boston Scientific Corp | 2016-08-11 |
| MEDTRONIC CARELINK ENCORE 29901 PROGRAMMER (P890003/S360) | Medtronic, Inc. | 2016-08-11 |
| PRESTIGE LP CERVICAL DISC SYSTEM (P090029/S005) | Medtronic Sofamor Danek USA, Inc. | 2016-08-11 |
| LT-CAGE LUMBAR TAPERED/INTER FIX THREADED/INTER FIX RP THREADED/PERIMETER INTERBODY FUSION DEVICE, CLYDESDALE SPINAL SYS (P000058/S061) | Medtronic Sofamor Danek USA, Inc. | 2016-08-11 |
| ADVIA CENTAUR HBC TOTAL ASSAY (P040004/S012) | Siemens Healthcare Diagnostics | 2016-08-11 |
| MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM SFA and PPA (P110040/S010) | Medtronic Vascular | 2016-08-10 |
| MYCARELINK PATIENT MONITOR, MYCARELINK READER FIELD REPLACEMENT UNIT (FRU), MYCARELINK SMART PATIENT READER, CARELINK EN (P890003/S362) | Medtronic, Inc. | 2016-08-10 |
| VALIANT THORACIC STENT GRAFT SYSTEM W/ the Captivia Delivery System (P100040/S027) | Medtronic Vascular | 2016-08-10 |
| SYNERGY EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P150003/S016) | Boston Scientific Corporation | 2016-08-10 |
| RESOLUTE INTEGRITY CORONARY STENT SYSTEM (P110013/S074) | Medtronic Vascular | 2016-08-10 |
| MEDTRONIC COREVALVE SYSTEM and Medtronic CoreValve Evolut R System (P130021/S023) | Medtronic, Inc. | 2016-08-10 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM Monorail & OTW (P130030/S025) | Boston Scientific Corp | 2016-08-10 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S025) | Boston Scientific Corp | 2016-08-10 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S026) | Boston Scientific Corp | 2016-08-10 |
| COMPLETE SE VASCULAR STENT SYSTEM Iliac (P090006/S018) | Medtronic Vascular | 2016-08-10 |
| VALITUDE CRT-P, ACCOLADE CRT-P (P030005/S140) | Guidant Corp. | 2016-08-10 |
| VISTAKON(etafilcon A) brand contact lenses (N18033/S082) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2016-08-10 |
| MEDTRONIC ENDURANT STENT GRAFT SYSTEM (P100021/S055) | Medtronic Vascular | 2016-08-10 |
| EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S076) | Boston Scientific Corp | 2016-08-10 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S129) | Boston Scientific Corp | 2016-08-10 |
| Integrity CORONARY STENT SYSTEMS (P030009/S088) | Medtronic, Ireland | 2016-08-10 |
| ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM (P110011/S012) | Medtronic, Ireland | 2016-08-10 |
| ROTABLATOR Rotational Atherectomy System (P900056/S154) | Boston Scientific Corp | 2016-08-10 |
| TALENT Occluder W Occluder Delivery System (P070027/S047) | Medtronic Vascular | 2016-08-10 |
| IN PACT ADMIRAL PACLITAXEL-Coated PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S021) | Medtronic, Inc. | 2016-08-10 |
| ALTRUA, ESSENTIO, PROPONENT, ACCOLADE PACEMAKERS (N970003/S192) | Boston Scientific Corp | 2016-08-10 |
| EXPRESS 2 MR & OTW (P020009/S128) | Boston Scientific Scimed, Inc. | 2016-08-10 |
| PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S128) | Boston Scientific Corp | 2016-08-10 |
| MINIMED 630G SYSTEM WITH SMARTGUARD(TM) (P150001) | Medtronic Minimed | 2016-08-10 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S015) | Boston Scientific Corporation | 2016-08-09 |
| BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S005) | Stryker Corporation | 2016-08-09 |
| PLATINIUM CRT-D 1711/1741 (P060027/S081) | MicroPort CRM USA, Inc. | 2016-08-09 |
| PLATINIUM VR 1210/1240, PLATINIUM DR 1510/1540 (ICD) (P980049/S115) | MicroPort CRM USA, Inc. | 2016-08-09 |
| Impella Ventricular Support Systems (P140003/S010) | Abiomed, Inc. | 2016-08-09 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S018) | ABBOTT MEDICAL | 2016-08-09 |
| IMPELLA VENTRICULAR SUPPORT SYSTEMS (P140003/S009) | Abiomed, Inc. | 2016-08-09 |
| ELECSYS ANTI-HBC IMMUNOASSAY (P100032/S011) | Roche Diagnostics Corp. | 2016-08-08 |
| ELECSYS HBSAG IMMUNOASSAY (P990012/S024) | Roche Diagnostics Corp. | 2016-08-08 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S083) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2016-08-08 |
| ELECSYS ANTI-HCV II IMMUNOASSAY (P140021/S003) | Roche Diagnostics Operations, Inc. | 2016-08-08 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY (P110022/S015) | Roche Diagnostics Corp. | 2016-08-08 |
| Platinium CRT-D 1711; Platinium CRT-D 1741 (P060027/S082) | MicroPort CRM USA, Inc. | 2016-08-08 |
| Elecsys Anti-HBc II, PreciControl Anti-HBc (P100031/S014) | Roche Diagnostics Corp. | 2016-08-08 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY (P110025/S013) | Roche Diagnostics Corp. | 2016-08-08 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY (P110031/S012) | Roche Diagnostics Corp. | 2016-08-08 |
| ELECSYS HBEAG IMMUNOASSAY (P130015/S005) | Roche Diagnostics Operations, Inc. | 2016-08-08 |
| Platinium VR 1210; Platinium VR 1240; Platinium DR 1510; Platinium DR 1540 (P980049/S116) | MicroPort CRM USA, Inc. | 2016-08-08 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S058) | Boston Scientific Corporation | 2016-08-08 |
| ELECSYS ANTI-HBS IMMUNOASSAY (P010054/S026) | Roche Diagnostics Corp. | 2016-08-08 |
| GEM II DR/GEM II VR/GEM III DR/GEM III VR/ENTRUST/INTRINSIC 30/INTRINSIC/MARQUIS DR/MARQUIS VR/MAXIMO II DR/MAXIMO II/MA (P980016/S592) | Medtronic Cardiac Rhythm Disease Management | 2016-08-07 |
| CONCERTO/CONCERTO II/CONSULTA DF4/CONSULTA/INSYNC II PROTECT/INSYNC III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/INSYNC II MA (P010031/S553) | Medtronic Cardiac Rhythm Disease Management | 2016-08-07 |
| GEM III AT ICD (P980050/S104) | Medtronic, Inc. | 2016-08-07 |
| COBAS HPV TEST (P100020/S020) | Roche Molecular Systems, Inc. | 2016-08-05 |
| ACRYSOF IQ TORIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM (P930014/S091) | Alcon Laboratories, Inc. | 2016-08-05 |