| ARCHITECT CORE-M (LN 6L23) (P060035/S025) | Abbott Laboratories | 2015-08-13 |
| TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS (P960013/S061) | ABBOTT MEDICAL | 2015-08-13 |
| ARCHITECT HBSAG QUALITATIVE (LN 4P53), ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54) (P110029/S022) | Abbott Laboratories | 2015-08-13 |
| ZILVER VASCULAR STENT (P050017/S011) | Cook Ireland, Ltd. | 2015-08-13 |
| PASSIVE PLUS, ISOFLEX S&P, AND ISOFLEX OPTIM LEADS (P960030/S031) | ABBOTT MEDICAL | 2015-08-13 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S235) | Medtronic, Inc. | 2015-08-13 |
| ARCHITECT AFP (LN 3P36) (P120008/S009) | Abbott Laboratories | 2015-08-13 |
| ARCHITECT ANTI-HCV (LN 1L79) (P050042/S032) | Abbott Laboratories, Inc. | 2015-08-13 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S015) | Cook Ireland, Ltd. | 2015-08-13 |
| ARCHITECT CORE (LN 6L22) (P080023/S027) | Abbott Laboratories | 2015-08-13 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S053) | Medtronic Vascular | 2015-08-12 |
| WALLSTENT ENDOPROSTHESIS TIPS (P930031/S054) | Boston Scientific Corp | 2015-08-12 |
| EXPRESS LD ILIAC PREMOUNTED SYSTEM (P090003/S037) | Boston Scientific Corporation | 2015-08-12 |
| WALLSTENT VENOUS ENDOPROSTHESIS (P980033/S043) | Boston Scientific Corporation | 2015-08-12 |
| VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM (P040016/S134) | Boston Scientific Scimed, Inc. | 2015-08-12 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED SYSTEM (P060006/S064) | Boston Scientific Corp | 2015-08-12 |
| H.E.L.P. PLASMAT FUTURA SYSTEM (P940016/S016) | B. Braun Avitum AG | 2015-08-11 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S028) | Smith & Nephew, Inc. | 2015-08-10 |
| ANIMAS VIBE SYSTEM (P130007/S006) | Animas Corp. | 2015-08-10 |
| VALITUDE CRT-P (P030005/S128) | Guidant Corp. | 2015-08-08 |
| ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 (N970003/S181) | Boston Scientific Corp | 2015-08-08 |
| INCEPTA, ENERGEN,PUNCTUA, DYNAGEN, INOGEN, ORIGEN ICD'S (P960040/S352) | Boston Scientific | 2015-08-08 |
| INCEPTA, ENERGEN, PUNCTUA, DYNAGEN,INOGEN,ORIGEN CRT-D (P010012/S396) | Boston Scientific Corp | 2015-08-08 |
| BELLAFILL PMMA COLLAGEN DERMAL FILLER (P020012/S011) | Tiger Aesthetics Medical, LLC | 2015-08-07 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS; THEON PERICARDIAL AORTIC BIOPROSTHESIS WITH THERMALFIX TI (P860057/S138) | Edwards Lifesciences, LLC | 2015-08-07 |
| ENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-LLIAC(AUI) STENT GRAFT SYSTEM, ENDURA (P100021/S048) | Medtronic Vascular | 2015-08-07 |
| EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S001) | Edwards Lifesciences, LLC | 2015-08-07 |
| ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S013) | Glaukos Corporation | 2015-08-07 |
| OVATION ABDOMINAL STENT GRAFT SYSTEM, OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, OVATION IX ILIAC STENT GRAFT (P120006/S021) | Endologix, LLC | 2015-08-07 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S040) | Edwards Lifesciences, LLC | 2015-08-07 |
| ASCENDRA + DELIVERY SYSTEM (P130009/S039) | Edwards Lifesciences, LLC | 2015-08-07 |
| BELOTERO BALANCE (P090016/S016) | Merz North America, Inc. | 2015-08-06 |
| THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER (P030031/S069) | Biosense Webster, Inc. | 2015-08-06 |
| THERMOCOOK SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER (P040036/S051) | Biosense Webster, Inc. | 2015-08-06 |
| THERASCREEN KRAS RGQ PCR KIT (P110027/S008) | QIAGEN GmbH | 2015-08-06 |
| THERASCREEN EGFR RGQ PCR KIT (P120022/S010) | QIAGEN GmbH | 2015-08-06 |
| INTEGRA DERMAL REGENERATION TEMPLATE, INTEGRA MESHED DERMAL REGENERATION TEMPLATE (P900033/S047) | Integra Lifesciences Corp. | 2015-08-06 |
| BELOTERO BALANCE (P090016/S009) | Merz North America, Inc. | 2015-08-06 |
| COFLEX INTERLAMINAR TECHNOLOGY (P110008/S003) | Companion Spine France | 2015-08-05 |
| NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED BREAST IMPLANTS (P040046/S013) | Allergan | 2015-08-05 |
| ORBERA INTRAGASTRIC BALLOON (P140008) | Boston Scientific Corporation | 2015-08-05 |
| RADIESSE DERMAL FILLER (P050037/S061) | Merz North America, Inc. | 2015-08-05 |
| VIDAS TOTAL PSA ASSAY (P040008/S012) | bioMerieux, Inc. | 2015-08-05 |
| RADIESSE, RADIESSE (+) (P050052/S071) | Merz North America, Inc. | 2015-08-05 |
| AMS 700, AMS AMBICOR, AMS 700 WITH MS PUMP INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S110) | Boston Scientific Corp | 2015-08-04 |
| GORE VIABAHN ENDOPROSTHESIS,GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S023) | W. L. Gore & Associates, Inc. | 2015-08-04 |
| GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S084) | W. L. Gore & Associates, Inc. | 2015-08-04 |
| MYNXGRIP VASCULAR CLOSURE DEVICES (P040044/S059) | Cordis US Corporation | 2015-08-03 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S023) | Allergan | 2015-08-03 |
| MYNX ACE VASCULAR CLOSURE DEVICE (P040044/S065) | Cordis US Corporation | 2015-08-03 |
| ZENITH TX2 TAA ENDOVASCULAR GRAFT (P070016/S010) | William Cook Europe Aps | 2015-08-03 |
| ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S001) | Boston Scientific Corporation | 2015-08-03 |
| GEL-ONE (P080020/S014) | Seikagaku Corp. | 2015-08-03 |
| MEDTRONIC COREVALVE (R) SYSTEM (P130021/S013) | Medtronic, Inc. | 2015-08-03 |
| NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS (P040046/S012) | Allergan | 2015-08-03 |
| DYNAGEN, INOGEN, ORIGEN, CRT-D DEVICES (P010012/S394) | Boston Scientific Corp | 2015-07-31 |
| PARADYM CRT-D 8750, PARADYM RF CRT-D9750 (ZL101), PARADYM RF CRT-D9750 (ZL102), INTENSIA CRT-D 174 (P060027/S078) | MicroPort CRM USA, Inc. | 2015-07-31 |
| ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG (P980035/S432) | Medtronic, Inc. | 2015-07-31 |
| PARADYM RF CRT-D9750 (ZL101) & (ZL102) ; INTENSIA CRT-D 174 (P060027/S077) | MicroPort CRM USA, Inc. | 2015-07-31 |
| PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL 101) & (ZL102) (P980049/S111) | MicroPort CRM USA, Inc. | 2015-07-31 |
| TECNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TENCNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TECNIS TORIC 1-PIECE INTRAOCU (P980040/S058) | Johnson & Johnson Surgical Vision, Inc. | 2015-07-31 |
| REVO MRI SURESCAN IPG (P090013/S194) | Medtronic, Inc. | 2015-07-31 |
| PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101), PARADYM RF VR 9750, PARADYM RF DR 9750 (P980049/S112) | MicroPort CRM USA, Inc. | 2015-07-31 |
| SMART AND SMART CONTROL NITINOL STENT SYSTEM (P020036/S031) | Cordis US Corporation | 2015-07-31 |
| ARCTIC FRONT ADVANCE ST (P100010/S050) | Medtronic Cryocath, LP | 2015-07-31 |
| ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/FLEXITIP XL-R (P050038/S025) | Davol, Inc. | 2015-07-31 |
| DYNAGEN, INOGEN, ORIGEN ICD DEVICES (P960040/S350) | Boston Scientific | 2015-07-31 |
| PARADYM VR 8750,PARADYM DR 8750,PARADYM RF VR 9750,PARADYM RF DR 9750(ZL101,ZL102)) (P980049/S110) | MicroPort CRM USA, Inc. | 2015-07-31 |
| SMART AND SMART CONTROL VASCULAR STENT SYSTEM (P120002/S006) | Cordis US Corporation | 2015-07-31 |
| CYBERONICS VNS THERAPY SYSTEM (P970003/S181) | LivaNova USA, Inc. | 2015-07-31 |
| SPRINT QUATTRO LEAD (P920015/S160) | Medtronic, Inc. | 2015-07-31 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S107) | MicroPort CRM USA, Inc. | 2015-07-31 |
| PROMETRA PROGRAMMABLE IMPLANTABLE PUMP (P080012/S028) | Infusyn Therapeutics, LLC | 2015-07-31 |
| PARADYM CRT-D 8750,PARADYM RF CRT-D 9750(ZL101),PARADYM RF CRT-D 9750 (ZL102),INTENSIA CRT-D (P060027/S076) | MicroPort CRM USA, Inc. | 2015-07-31 |
| REPLY SR,REPLY DR,ESPRIT SR, ESPRIT DR (P950029/S106) | MicroPort CRM USA, Inc. | 2015-07-31 |
| PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S217) | Boston Scientific Corp | 2015-07-30 |
| GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S083) | W. L. Gore & Associates, Inc. | 2015-07-30 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S114) | Boston Scientific Corp | 2015-07-30 |
| GORE VIABAHN ENDOPROSTHESIS,GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S082) | W. L. Gore & Associates, Inc. | 2015-07-30 |
| THERAKOS CELLEX PROCEDURAL KIT (P860003/S080) | Therakos Development Limited | 2015-07-30 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S016) | Abbott Vascular, Inc. | 2015-07-30 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE, GORE VIABAHN ENDOPROSTHESIS (P130006/S022) | W. L. Gore & Associates, Inc. | 2015-07-30 |
| GORE VIABAHN ENDR0PROSTHESIS WITH HEPARIN BIOACTIVE SURFAC, GORE VIABAHN ENDOPROTHESIS (P130006/S021) | W. L. Gore & Associates, Inc. | 2015-07-30 |
| PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S023) | Infusyn Therapeutics, LLC | 2015-07-29 |
| FREEDOM DRIVER SYSTEM (P030011/S031) | Syncardia Systems, LLC | 2015-07-29 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S016) | Cardiva Medical, Inc. | 2015-07-29 |
| STRAUMANN EMDOGAIN (P930021/S015) | The Straumann Company | 2015-07-29 |
| ENLITE SENSOR (P120010/S067) | Medtronic, Inc. | 2015-07-29 |
| RESHAPE INTEGRATED DUAL BALLOON SYSTEM (P140012) | Boston Scientific Corporation | 2015-07-28 |
| BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P780007/S054) | CooperVision, Inc. | 2015-07-28 |
| ALERE NMP22 BLADDERCHEK TEST (P940035/S011) | Abbott Diagnostics Scarborough, Inc. | 2015-07-28 |
| HV SPLITTER/ADAPTOR KIT, SPRINT QUATTRO LEAD, SPRINT QUATTRO LEAD (P920015/S161) | Medtronic, Inc. | 2015-07-28 |
| ELECSYS HBEAG IMMUNOASSAY/ELECSYS PRECICONTROL HBEAG (P130015/S003) | Roche Diagnostics Operations, Inc. | 2015-07-28 |
| 5F MYNXGRIP VASCULAR CLOSURE DEVICE (MX5021) (P040044/S064) | Cordis US Corporation | 2015-07-28 |
| BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P080011/S038) | CooperVision, Inc. | 2015-07-28 |
| BIOMEDICS 55 (OCUFILCON D) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P890023/S023) | The Cooper Companies | 2015-07-28 |
| IMMULITE ANTI-HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) SYSTEMS (P010052/S012) | Siemens Healthcare Diagnostics Products, Ltd. | 2015-07-27 |
| MINERVA ENDOMETRIAL ABLATION SYSTEM (P140013) | Axora Medical, Inc. | 2015-07-27 |
| SYNVISC, SYNVISC-ONE (P940015/S034) | Sanofi Genzyme Corp. | 2015-07-24 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S009) | Abbott Vascular (Idef Technologies Inc) | 2015-07-24 |