| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S127) | Abbott Vascular, Inc. | 2015-02-06 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEMS,XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS,XIENCE (P110019/S074) | Abbott Vascular | 2015-02-06 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S054) | Abbott Vascular | 2015-02-06 |
| ABSOLUTE PRO VASCULAR STENT SYSTEMS (P110028/S014) | Abbott Vascular, Inc. | 2015-02-06 |
| INTERSTIM THERAPY SYSTEM (P970004/S188) | Medtronic Neuromodulation | 2015-02-06 |
| SYNCHROMED IMPLANTABLE INFUSION PUMPS (P860004/S219) | Medtronic, Inc. | 2015-02-06 |
| INTERSTIM THERAPY SYSTEM (P080025/S084) | Medtronic Neuromodulation | 2015-02-06 |
| MULTI-LINK VISION,MULTI-LINK MINI VISION,MULTI-LINK 8 CORONARY STENT SYSTEMS (P020047/S061) | Abbott Vascular | 2015-02-06 |
| MOBI-C CERVICAL DISC PROSTHESIS (P110002/S009) | Highridge Medical, LLC | 2015-02-05 |
| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM (P910001/S077) | Spectranetics Corp. | 2015-02-05 |
| MOBI-C CERVICAL DISC PROSTHESIS (P110009/S009) | Highridge Medical, LLC | 2015-02-05 |
| INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE (P900033/S026) | Integra Lifesciences Corp. | 2015-02-05 |
| EDWARDS EXPANDABLE INTRODUCER SHEATH SET (P130009/S023) | Edwards Lifesciences, LLC | 2015-02-05 |
| INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S002) | Inspire Medical Systems | 2015-02-05 |
| MINILINK TRANSMITTER, WATERTIGHT TESTER, MINILINK KIT WITH ENLITE SERTER AND MINILINK REPLACEMENT KIT (P120010/S026) | Medtronic, Inc. | 2015-02-04 |
| ENLITE SENSOR (P120010/S030) | Medtronic, Inc. | 2015-02-04 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S113) | Boston Scientific Corp | 2015-02-04 |
| FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE (P950020/S071) | Boston Scientific Corp | 2015-02-04 |
| MONOVISC (P090031/S003) | Anika Therapeutics, Inc. | 2015-02-04 |
| THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S077) | Therakos Development Limited | 2015-02-03 |
| COHERA MEDICAL TISSUGLU (P130023) | Cohera Medical, Inc. | 2015-02-03 |
| AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS (P060022/S020) | Bausch & Lomb, Inc. | 2015-02-03 |
| BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA) (P100025/S007) | Meridian Bioscience, Inc. | 2015-02-03 |
| AORFIX AND AORFIX PLUS AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE (P110032/S010) | Lombard Medical Limited | 2015-02-03 |
| TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION IX ILIAC STENT GRAFT (P120006/S015) | Endologix, LLC | 2015-02-02 |
| CONSULTA CRT-P, SYNERA CRT-P, VIVA CRT-P (P010015/S256) | Medtronic, Inc. | 2015-02-02 |
| DEXTRUS, SETROX S, TILDA, SAFIO S (P950037/S146) | Biotronik, Inc. | 2015-02-02 |
| ADVIA CENTAUR HBSAGII ASSAY (P110041/S001) | Siemens Corp. | 2015-02-02 |
| LINOX SMART SD, LINOX SMART S, VOLTA 1CR, VOLTA 2CR (P980023/S063) | Biotronik, Inc. | 2015-02-02 |
| COLOGUARD (P130017/S001) | Exact Sciences Corporation | 2015-02-02 |
| LIVEWIRE TC ABLATION CATHETER AND SAFIRE BI-DIRECTIONAL ABLATION CATHETER (P960016/S051) | St Jude Medical | 2015-02-02 |
| EDWARDS SAPIEN CT TRANSCATHETER HEART VALVE (P130009/S022) | Edwards Lifesciences, LLC | 2015-01-30 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S049) | Edwards Lifesciences, LLC | 2015-01-30 |
| ESTEEM SYSTEM (P090018/S028) | Envoy Medical Corporation | 2015-01-30 |
| ENLITE GLUCOSE SENSOR. (P120010/S055) | Medtronic, Inc. | 2015-01-30 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S131) | Edwards Lifesciences, LLC | 2015-01-30 |
| RADIESSE (+) LIDOCAINE DERMAL FILTER (P050052/S052) | Merz North America, Inc. | 2015-01-30 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S062) | Edwards Lifesciences, LLC | 2015-01-30 |
| THXID-BRAF KIT (P120014/S001) | bioMerieux, Inc. | 2015-01-30 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO I (P980016/S513) | Medtronic Cardiac Rhythm Disease Management | 2015-01-30 |
| CERAMAX (R) CERAMIC TOTAL HIP SYSTEM (P070026/S023) | DePuy Orthopaedics, Inc. | 2015-01-30 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO 11 CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA XT CRT-D, PROTECTA XT CRT-D, (P010031/S477) | Medtronic Cardiac Rhythm Disease Management | 2015-01-30 |
| NG3 FAMILY OF CRT-D'S (ORIGEN, INOGEN, & DYNAGEN); PROGENY FAMILY OF CRT-D'S (INCEPTA, ENERGEN, & PUNCTUA) (P010012/S376) | Boston Scientific Corp | 2015-01-29 |
| IN PACT ADMIRAL PACLITAXEL-COATING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLON CATHETER (P140010/S001) | Medtronic, Inc. | 2015-01-29 |
| NG3 FAMILY OF ICD'S (ORIGEN, INOGEN, & DYNAGEN); PROGENY FAMILY OF ICD'S (INCEPTA, ENERGEN, & PUNCTUA) (P960040/S336) | Boston Scientific | 2015-01-29 |
| ENLITE SENSOR (P120010/S042) | Medtronic, Inc. | 2015-01-29 |
| ENLITE GLUCOSE SENSORS (P120010/S053) | Medtronic, Inc. | 2015-01-29 |
| SOF-SENSOR (P980022/S167) | Medtronic Minimed | 2015-01-29 |
| FORTIFY VR,FORTIFY DR,FORTIFY ASSURA VR, FORTIFY ASSURA DR ICDS (P910023/S351) | ABBOTT MEDICAL | 2015-01-28 |
| GUARDIAN REAL TIME MONITOR (P980022/S168) | Medtronic Minimed | 2015-01-28 |
| UNIFY,UNIFY ASSURA,UNIFY QUADRA,QUADRA ASSURA CRT-DS (P030054/S280) | ABBOTT MEDICAL | 2015-01-28 |
| ENLITE GLUCOSE SENSORS (P120010/S041) | Medtronic, Inc. | 2015-01-28 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S102) | Boston Scientific Corp | 2015-01-28 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S019) | OraSure Technologies, Inc. | 2015-01-28 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S053) | Boston Scientific Corp | 2015-01-28 |
| MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) (P140017) | Medtronic, Inc. | 2015-01-27 |
| JUVEDERM VOLUMA XC (P110033/S011) | Allergan | 2015-01-27 |
| VISIONCARE IMPLANTABLE MINIATURE TELESCOPE (P050034/S015) | Samsara Vision, Inc. | 2015-01-27 |
| INFUSE(R) BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S058) | Medtronic Sofamor Danek USA, Inc. | 2015-01-27 |
| PIPELINE EMBOLIZATION DEVICES,PIPELINE FLEX EMBOLIZATION DEVICE (P100018/S011) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015-01-26 |
| EVERA S DR/S VR,XT DR, XT VR ICD; ENTRUST; INTRINSIC 30 & INTRINSIC ICD; MARQUIS DR, VR ICD; MAXIMO DR, II, VR ICD; PROT (P980016/S492) | Medtronic Cardiac Rhythm Disease Management | 2015-01-26 |
| MYCARELINK SMART MONITOR AND THE MYCARELINK HEART APPLICATION (P890003/S313) | Medtronic, Inc. | 2015-01-26 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ENTHYTHM, KAPPA D (KAPPA 700) IPG & KAPA (P980035/S384) | Medtronic, Inc. | 2015-01-26 |
| REVO MRI IPG (P090013/S149) | Medtronic, Inc. | 2015-01-26 |
| MELAFIND (P090012/S008) | Strata Skin Sciences, Inc. | 2015-01-26 |
| BRAVA CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA ICD, INSYNC II PROTECT ICD ,III MARQUIS ICD, INSYNC MAXIMO ICD, (P010031/S455) | Medtronic Cardiac Rhythm Disease Management | 2015-01-26 |
| CONSULTA CRT-P, SYNERA CRT-P (P010015/S244) | Medtronic, Inc. | 2015-01-26 |
| FLEXABILITY ABLATION CATHETER (P110016/S013) | ABBOTT MEDICAL | 2015-01-23 |
| DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM, DEXCOM SHARE SYSTEM (P120005/S028) | Dexcom, Inc. | 2015-01-23 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S127) | Cochlear Americas | 2015-01-23 |
| NUCLEUS 24 HYBRID SYSTEM (P130016/S010) | Cochlear Americas | 2015-01-23 |
| LUTONIX DRUG COATED BALLOON (DCB) (P130024/S001) | Lutonix | 2015-01-22 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S110) | W. L. Gore & Associates, Inc. | 2015-01-22 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S049) | Vistakon, Division of Johnson & Johnson Vision Car | 2015-01-22 |
| NUCLEUS CI512 COCHLEAR IMPLANT (P970051/S116) | Cochlear Americas | 2015-01-22 |
| BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES (P080011/S034) | CooperVision, Inc. | 2015-01-22 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S071) | W. L. Gore & Associates, Inc. | 2015-01-22 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S032) | Dexcom, Inc. | 2015-01-22 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S075) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2015-01-22 |
| ENDURANT AND ENDURANT II STENT SYSTEM, ENDURANT II AORTO-UNI-LLIAC(AUI) STENT GRAFT SYSTEM, ENDURANT IIS STENT GRAFT SYS (P100021/S041) | Medtronic Vascular | 2015-01-22 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S211) | Boston Scientific Corp | 2015-01-21 |
| EASYTRAK 2+ IS-1 CORONARY VENOUS STEROID ELUTING DUAL ELECTRODE PACE/SENSE LEADS (P010012/S380) | Boston Scientific Corp | 2015-01-21 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, (P010031/S479) | Medtronic Cardiac Rhythm Disease Management | 2015-01-21 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S011) | Torax Medical | 2015-01-21 |
| SOLESTA INJECTABLE GEL (P100014/S017) | Palette Life Sciences | 2015-01-21 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM- MONORAIL AND ION PACLITAXEL-ELUTING CORONAY STENT SYSTEM- OVER THE WIRE (P100023/S104) | Boston Scientific Corp | 2015-01-21 |
| NIT-OCCLUD SYSTEM (P120009/S002) | Pfm Medical, Inc. | 2015-01-21 |
| BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES (P080011/S033) | CooperVision, Inc. | 2015-01-21 |
| PROTEGE GPS SELF EXPANDING PERIPHERAL STENT SYSTEM (P060001/S020) | Medtronic Vascular, Inc. | 2015-01-21 |
| EUFLEXXA (P010029/S021) | Ferring Pharmaceuticals, Inc. | 2015-01-21 |
| LCS TOTAL KNEE SYSTEM (P830055/S154) | Depuy, Inc. | 2015-01-21 |
| PROGENSA PCA3 ASSAY (P100033/S002) | Gen-Probe Incorporated | 2015-01-21 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA (P980016/S515) | Medtronic Cardiac Rhythm Disease Management | 2015-01-21 |
| MTROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S022) | Corcym Canada Corp | 2015-01-21 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S079) | Med-El Corp. | 2015-01-20 |
| PERCLOSE PROGLIDE SUTURE- MEDIATED CLOSURE SYSTEM, PERCLOSE A-T SUTURE-MEDIATED CLOSURE SYSTEM (P960043/S089) | Abbott Vascular, Inc. | 2015-01-20 |
| WAVELIGHT EX500 LASER SYSTEM (P020050/S018) | Alcon Laboratories, Inc. | 2015-01-20 |
| WAVELIGHT EX500 LASER SYSTEM (P030008/S016) | Alcon Laboratories, Inc. | 2015-01-20 |
| NEUROPACE RNS SYSTEM (P100026/S027) | NeuroPace, Inc. | 2015-01-16 |
| NATRELLE SILICONE GEL-FILLED BREAST IMPLANTS (P020056/S029) | Allergan | 2015-01-16 |