| PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEM (P960043/S091) | Abbott Vascular, Inc. | 2015-12-31 |
| FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CATHETER (P020045/S069) | Medtronic Cryocath, LP | 2015-12-31 |
| RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT (P140012/S004) | Boston Scientific Corporation | 2015-12-31 |
| ACRYSOF INTRAOCULAR LENS (P930014/S087) | Alcon Laboratories, Inc. | 2015-12-31 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S138) | Cochlear Americas | 2015-12-30 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS) (P050039/S018) | Exactech, Inc. | 2015-12-30 |
| SYNCHROMED INFUSION SYSTEM (P860004/S235) | Medtronic, Inc. | 2015-12-30 |
| CERAMIC TRANSCEND ARTICULATION SYSTEM (P030027/S008) | Microport Orthopedics, Inc. | 2015-12-30 |
| NUCLEUS 24 HYBRID SYSTEM (P130016/S013) | Cochlear Americas | 2015-12-30 |
| ALAIR BRONCHIAL THERMOPLASTY SYSTEM (P080032/S016) | Boston Scientific Corp | 2015-12-29 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (MAESTRO COCHLEAR IMPLANT SYSTEM) (P000025/S083) | Med-El Corp. | 2015-12-29 |
| RADIESSE INJECTABLE IMPLANT (P050037/S064) | Merz North America, Inc. | 2015-12-29 |
| UROVYSION BLADDER CANCER KIT,PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT (P030052/S017) | Abbott Molecular | 2015-12-29 |
| RADIESSE (+) LIDOCAINE DERMAL FILLER (P050052/S075) | Merz North America, Inc. | 2015-12-29 |
| PROMETRA PROGRAMMABLE PUMP SYSTEM (P080012/S031) | Infusyn Therapeutics, LLC | 2015-12-28 |
| ANIMAS VIBE SYSTEM (P130007/S004) | Animas Corp. | 2015-12-24 |
| LCS TOTAL KNEE SYSTEM (P830055/S165) | Depuy, Inc. | 2015-12-23 |
| COLOGUARD (P130017/S005) | Exact Sciences Corporation | 2015-12-23 |
| INTERSTIM THERAPY SYSTEM (P080025/S103) | Medtronic Neuromodulation | 2015-12-23 |
| MINIMED 530G SYSTEM (P120010/S080) | Medtronic, Inc. | 2015-12-23 |
| PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM (P980022/S189) | Medtronic Minimed | 2015-12-23 |
| RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME,SPECIFY, & VECTRIS CORD STIMULATION LEADS (P840001/S318) | Medtronic Neuromodulation | 2015-12-23 |
| INTERSTIM THERAPY SYSTEM (P970004/S208) | Medtronic Neuromodulation | 2015-12-23 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S242) | Medtronic, Inc. | 2015-12-23 |
| SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES-HEALON, HEALON GV, HEALON5 PRODUCTS, HEALON ULTIMATE DUAL PACK, AND H (P810031/S055) | Johnson & Johnson Surgical Vision, Inc. | 2015-12-22 |
| HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICES (OVD), (3% SODIUM HYALURONATE) (P110007/S007) | Johnson & Johnson Surgical Vision, Inc. | 2015-12-22 |
| CARDIOGENESIS TMR SYSTEM (P970029/S028) | Cryolife, Inc. | 2015-12-22 |
| TACTICATH QUARTZ SET (P130026/S013) | St Jude Medical | 2015-12-22 |
| BRACANALYSIS CDX (P140020/S004) | Myriad Genetic Laboratories | 2015-12-22 |
| NOVAFLEX+ DELIVERY SYSTEM (P130009/S043) | Edwards Lifesciences, LLC | 2015-12-21 |
| IFORIA 7 DR-T (DF-1 & DF4), IPERIA 7 DR-T (DF-1 & DF-4), INVENTRA 7 DR-T (DF-1 & DF-4) (P050023/S087) | Biotronik, Inc. | 2015-12-21 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S237) | Medtronic, Inc. | 2015-12-21 |
| INTERSTIM THERAPY SYSTEM (P970004/S204) | Medtronic Neuromodulation | 2015-12-21 |
| FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL) ; FLEXABILITY ABLATION CATHETER(UNI-DIRECTIONAL) (P110016/S028) | ABBOTT MEDICAL | 2015-12-21 |
| SYNCHROMED INFUSION SYSTEM (P860004/S236) | Medtronic, Inc. | 2015-12-21 |
| PROGRAMMER SOFTWARE(1503.U) FOR ICS 3000/RENAMIC PROGRAMMERS (P000009/S063) | Biotronik, Inc. | 2015-12-21 |
| INTERSTIM THERAPY SYSTEM (P080025/S099) | Medtronic Neuromodulation | 2015-12-21 |
| PROGRAMMER SOFTWARE (1503.U) FOR THE ICS 3000/RENAMIC PROGRAMMERS (P070008/S063) | Biotronik, Inc. | 2015-12-21 |
| LINOX SMART S65,LINOX SMART SD 65/18,LINOX S DX 65/15,LINOX S DX 65/17,PROTEGO DF-1 S 65,PROTEGO DF-1 SD 65/18,PROTEGO D (P980023/S072) | Biotronik, Inc. | 2015-12-21 |
| LINOX SMART(S65)(SD65/18)(SDX65/15&65/17),PROTEGO DF-1(S65)(SD65/18)(DX65/15&65/17),PROTEGO(S65&75)(SD65/16,65/18,75/18) (P950037/S151) | Biotronik, Inc. | 2015-12-21 |
| ORIGEN, INOGEN, AND DYNAGEN ICD, INCEPTA, ENERGEN, AND PUNCTUA ICD, TELIGEN ICD (P960040/S360) | Boston Scientific | 2015-12-21 |
| RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,RESUME,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION (P840001/S312) | Medtronic Neuromodulation | 2015-12-21 |
| RESHAPE INTEGRATED DUAL BALLOON SYSTEM,RESHAPE BALLOON ASSEMBLY,RESHAPE REMOVAL CATHETER,RESHAPE VALVE SEALANT (P140012/S002) | Boston Scientific Corporation | 2015-12-21 |
| VISCO-3 (P980044/S027) | Seikagaku Corp. | 2015-12-21 |
| ORIGEN, INOGEN, AND DYNAGEN CRT-D, INCEPTA ENERGEN PUNCTUA CRT-D, COGNIS CRT-D (P010012/S405) | Boston Scientific Corp | 2015-12-21 |
| BIOTRONIK ICD FAMILIES (P050023/S090) | Biotronik, Inc. | 2015-12-18 |
| ONYX 18, ONYX LIQUID EMBOLIC SYSTEM, ONYX 34,ONYX LIQUID EMBOLIC SYSTEM, APPOLLO ONYX DELIVERY MICRO CATHETER 1.5CM, STR (P030004/S009) | Ev3 Neurovascular | 2015-12-18 |
| ASPIRESR GENERATOR -MODEL 106 (P970003/S182) | LivaNova USA, Inc. | 2015-12-18 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S054) | Boston Scientific Corp | 2015-12-18 |
| ELCA CORONARY LASER ATHERCOTOMY CATHETER (ELCA 2.0 VITESSE ELL) (P910001/S082) | Spectranetics Corp. | 2015-12-18 |
| BRIO LE CHARGING SYSTEM (P140009/S005) | ABBOTT MEDICAL | 2015-12-18 |
| EON CHARGING SYSTEM, EON MINI LE CHARGING SYSTEM, PRODIGY CHARGING SYSTEM (P010032/S102) | ABBOTT MEDICAL | 2015-12-18 |
| PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S243) | Boston Scientific Corp | 2015-12-18 |
| ALGOVITA SPINAL CORD STIMULATION SYSTEM (P130028/S001) | Nuvectra Corporation | 2015-12-18 |
| ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM (P140030) | Biotronik AG | 2015-12-17 |
| CELSIUS RMT THERMOCCOL CAT, CELSIUS THERMOCCOL CATH NAVISTAR & RMT THERMOCOOL CATHS,THERMOCOOL SF, SMARTTOUCH& NAV CATH (P030031/S059) | Biosense Webster, Inc. | 2015-12-17 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S056) | Zoll Manufacturing Corporation | 2015-12-17 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047/S041) | Neomend, Inc. | 2015-12-17 |
| BIOSENSE WEBSTER CABLES (P990071/S028) | Biosense Webster, Inc. | 2015-12-17 |
| REFLECTION CERAMIC ACETABULAR HIPS SYSTEM (RCHS) (P030022/S034) | Smith & Nephew, Inc. | 2015-12-17 |
| EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS (P790005/S053) | Ahp Eos Buyer, Inc. | 2015-12-17 |
| BIOSENSE WEBSTER CABLES, CELSIUS CATHETER, CELSIUS RMT CATHETER, CLESIUS FLTR, DEFLECTABLE DISGNOSTIC/ABLATION CATHETER (P950005/S051) | Biosense Webster, Inc. | 2015-12-17 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S022) | Boston Scientific Corp | 2015-12-17 |
| EZ STEER THERMOCOOL CATH, EZ STEER THERMOCOOL NAV CATH NAVISTAR RMT THERMOCOOL & THERMOCOOL CATH, THERMOCOOL SMARTTOUCH (P040036/S044) | Biosense Webster, Inc. | 2015-12-17 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM (P110023/S016) | Medtronic Vascular, Inc. | 2015-12-17 |
| ACTIVL ARTIFICIAL DISC (P120024/S003) | Highridge Medical, LLC | 2015-12-17 |
| BLAZER PRIME HTD, BLAZER II, BLAZER II HTD (P920047/S087) | Boston Scientific Corp | 2015-12-17 |
| BLAZER II XP, BLAZER PRIME XP AND INTELLA TIP MIFI XP (P020025/S081) | Boston Scientific | 2015-12-17 |
| BIOSENSE WEBSTER CABLES, CELSIUS DS CATHETER, CELSIUS FLTR, EZ STEER NAV DS CATH, NAVISTAR DS CATH, NAVISTAR RMT DS CATH (P010068/S040) | Biosense Webster, Inc. | 2015-12-17 |
| BIOSENSE WEBSTER CABLES, EZ STEER NAV CATHETER, NAVISTAR CATHETER, NAVISTAR RMT CATHETER (P990025/S040) | Biosense Webster, Inc. | 2015-12-17 |
| SPF-XL IIB 2/DM IMPLANTABLE SPINAL FUSION STIMULATORS, SPF-PLUS-MINI SPINAL FUSION STIMULATORS (P850035/S040) | Ahp Eos Buyer, Inc. | 2015-12-17 |
| LIFE PULSE HIGH FREQUENCY VENTILATOR, PATIENT BOX (P850064/S028) | Bunnell, Inc. | 2015-12-17 |
| OPEN PIVOT AORTIC VALVED GRAFT (P990046/S043) | Medtronic Ats Medical, Inc. | 2015-12-16 |
| CAPSUREFIX MRI LEAD (P090013/S210) | Medtronic, Inc. | 2015-12-16 |
| CAPSURE SENSE LEAD (P830061/S124) | Medtronic Cardiac Rhythm Disease Management | 2015-12-16 |
| ADAPTA, VERSA, SENSIA IPG (P980035/S448) | Medtronic, Inc. | 2015-12-16 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S078) | W. L. Gore & Associates, Inc. | 2015-12-16 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S012) | Abbott Vascular (Idef Technologies Inc) | 2015-12-16 |
| CAPSUREFIX NOVUS LEAD (P930039/S144) | Medtronic, Inc. | 2015-12-16 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S124) | W. L. Gore & Associates, Inc. | 2015-12-16 |
| OPEN PIVOT HEART VALVE,OPEN PIVOT AORTIC VALVED GRAFT,OPEN PIVOT HEART VALVE-APEX,OPEN PIVOT HEART VALVE-AP360 (P990046/S044) | Medtronic Ats Medical, Inc. | 2015-12-16 |
| VITROS IMMUNADIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATO (P000014/S029) | Ortho-Clinical Diagnostics, Inc. | 2015-12-16 |
| CAROTID WALLSTENT MONORAIL STENT SYSTEM (P050019/S023) | Boston Scientific Corp | 2015-12-16 |
| PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS (P980006/S025) | Bausch & Lomb, Inc. | 2015-12-16 |
| DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE (P020027/S022) | Siemens Healthcare Diagnostics | 2015-12-15 |
| CERAMAX CERAMIC TOTAL HIP SYSTEM. (P070026/S033) | DePuy Orthopaedics, Inc. | 2015-12-15 |
| DIMENSION TPSA FLEX REAGENT CARTRIGE AND DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE (P000021/S027) | Siemens Healthcare Diagnostics | 2015-12-15 |
| ANTHEM, ALLURE RF, ALLURE QUADRA, ALLURE QUADRA RF FAMILY OF CRT-P DEVICES (P030035/S143) | ABBOTT MEDICAL | 2015-12-15 |
| CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILES OF ICD DEVICES (P910023/S366) | ABBOTT MEDICAL | 2015-12-15 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S046) | W. L. Gore & Associates, Inc. | 2015-12-15 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S069) | Medtronic | 2015-12-15 |
| SUPERION INTERSPINOUS SPACER (P140004/S002) | Boston Scientific Neuromodulation | 2015-12-15 |
| RESTYLANE, RESTYLANE-L, PERLANE, PERLANE-L, RESTYLANE SILK (P040024/S083) | Q-Med AB | 2015-12-15 |
| VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX FAMILY OF PACEMAKERS DEVICES (P880086/S265) | ABBOTT MEDICAL | 2015-12-15 |
| PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S296) | ABBOTT MEDICAL | 2015-12-15 |
| LCS TOTAL KNEE SYSTEM (P830055/S166) | Depuy, Inc. | 2015-12-15 |
| PROTEGE GPS STENT SYSTEM (P060001/S024) | Medtronic Vascular, Inc. | 2015-12-14 |
| ANGIOJET ULTRA XMI THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY (P980037/S046) | Boston Scientific Corp | 2015-12-14 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S018) | Cardiva Medical, Inc. | 2015-12-14 |
| TECNIS 1-PIECE IOL, TECNIS OPTIBLUE 1-PIECE, TECNIS MULTIFOCAL 1-PIECE IOL (P980040/S063) | Johnson & Johnson Surgical Vision, Inc. | 2015-12-14 |