| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S051) | Edwards Lifesciences, LLC | 2014-04-17 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S091) | Medtronic, Inc. | 2014-04-17 |
| SMART AND SMART CONTROL VASCULAR STENT SYSTEM (P120002/S001) | Cordis US Corporation | 2014-04-16 |
| SMART AND SMART CONTROL NITINOL STENT SYSTEM (P020036/S026) | Cordis US Corporation | 2014-04-16 |
| PARADYM RF VR (P980049/S095) | MicroPort CRM USA, Inc. | 2014-04-16 |
| PARADYM RF CRT-D (P060027/S062) | MicroPort CRM USA, Inc. | 2014-04-16 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S004) | Bolton Medical, Inc. | 2014-04-16 |
| ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY (P110029/S017) | Abbott Laboratories | 2014-04-15 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG (P980035/S370) | Medtronic, Inc. | 2014-04-15 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S121) | Abbott Vascular, Inc. | 2014-04-15 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S065) | Abbott Vascular | 2014-04-15 |
| INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S153) | Medtronic Neuromodulation | 2014-04-15 |
| ARCHITECT AFP (P120008/S006) | Abbott Laboratories | 2014-04-15 |
| S-ICD SYSTEM (P110042/S028) | Boston Scientific Corporation | 2014-04-15 |
| EVERA S DR ICD, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD,PROTECTA ICD, PROTECTA (P980016/S475) | Medtronic Cardiac Rhythm Disease Management | 2014-04-15 |
| ARCHITECT AUSAB (P050051/S026) | Abbott Laboratories, Inc. | 2014-04-15 |
| REVO MRI IPG (P090013/S137) | Medtronic, Inc. | 2014-04-15 |
| INTERSTIM THERAPY FOR BOWEL CONTROL (P080025/S049) | Medtronic Neuromodulation | 2014-04-15 |
| MULTI-LINK VISION / MULTI-LINK MINI VISION / MULTI-LINK 8 CORONARY STENT SYSTEMS (P020047/S057) | Abbott Vascular | 2014-04-15 |
| BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA S CRT-D, VIVA XT (P010031/S436) | Medtronic Cardiac Rhythm Disease Management | 2014-04-15 |
| NEUROPACE RNS SYSTEM (P100026/S015) | NeuroPace, Inc. | 2014-04-14 |
| DIGENE HC2 HIGH RISK HPV DNA TEST AND DIGENE HC2 HPV DNA TEST (P890064/S029) | Qiagen Gaithersburg, Inc. | 2014-04-14 |
| JUVEDERM VOLUMA XC (P110033/S005) | Allergan | 2014-04-14 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S036) | Allergan | 2014-04-14 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S114) | Cochlear Americas | 2014-04-14 |
| TECNIS TORIC 1-PIECE INTRAOCULAR LENSES (IOLS) (P980040/S044) | Johnson & Johnson Surgical Vision, Inc. | 2014-04-14 |
| SNS BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY (P080025/S065) | Medtronic Neuromodulation | 2014-04-11 |
| DYNAGEN EL & MINI ICD'S; INOGEN EL & MINI ICD'S; ORIGEN EL & MINI ICD'S; TELIGEN ICD (P960040/S306) | Boston Scientific | 2014-04-11 |
| MODEL 3140 ZOOM WIRELESS TRANSMITTER AND MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM) (P910077/S139) | Boston Scientific | 2014-04-11 |
| DYNAGEN & DYNAGEN X4 CRT-D'S; INOGEN & INOGEN X4 CRT-D'S; ORIGEN & ORIGEN X4 CRT-D'S; COGNIS CRT-D (P010012/S341) | Boston Scientific Corp | 2014-04-11 |
| CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S420) | Medtronic Cardiac Rhythm Disease Management | 2014-04-11 |
| ADAPTA, VERSA, SENSIA IPG, RELIA IPG (P980035/S371) | Medtronic, Inc. | 2014-04-11 |
| SNS URINARY NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY (P970004/S169) | Medtronic Neuromodulation | 2014-04-11 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S458) | Medtronic Cardiac Rhythm Disease Management | 2014-04-11 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S091) | Boston Scientific Corp | 2014-04-11 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE BIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S001) | W. L. Gore & Associates, Inc. | 2014-04-10 |
| SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S081) | St. Jude Medical, Inc. | 2014-04-10 |
| SCS NEUROSTIMULATORS IMPLANTABLE ITREL FAMILY (P840001/S265) | Medtronic Neuromodulation | 2014-04-10 |
| CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICES (P010015/S205) | Medtronic, Inc. | 2014-04-10 |
| WAVELIGHT EX500 EXCIMER LASER SYSTEM (P020050/S015) | Alcon Laboratories, Inc. | 2014-04-10 |
| NUVISC (P000046/S023) | Anika Therapeutics, Inc. | 2014-04-10 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S050) | ABBOTT MEDICAL | 2014-04-10 |
| INTERSTIM II NEUROSTIMULATOR (P970004/S170) | Medtronic Neuromodulation | 2014-04-10 |
| CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICES (P010031/S381) | Medtronic Cardiac Rhythm Disease Management | 2014-04-10 |
| INTERSTIM II BOWEL NEUROSTIMULATOR (P080025/S066) | Medtronic Neuromodulation | 2014-04-10 |
| BELOTERO BALANCE DERMAL FILLER (P090016/S008) | Merz North America, Inc. | 2014-04-10 |
| FRONTIER/ FRONTIER II /ANTHEM FAMILY OF CRT-P'S (P030035/S098) | ABBOTT MEDICAL | 2014-04-10 |
| WAVELIGHT EX500 EXCIMER LASER SYSTEM (P030008/S013) | Alcon Laboratories, Inc. | 2014-04-10 |
| EPIC HF/ATLAS + HF/QUANDRA ASSURA/UNIFY ASSURA FAMILY OF CRT-D'S (P030054/S226) | ABBOTT MEDICAL | 2014-04-10 |
| EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S476) | Medtronic Cardiac Rhythm Disease Management | 2014-04-10 |
| CADENCE/ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S (P910023/S297) | ABBOTT MEDICAL | 2014-04-10 |
| SYNCHROMED II INFUSION PUMP (P860004/S203) | Medtronic, Inc. | 2014-04-10 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S043) | Vistakon, Division of Johnson & Johnson Vision Car | 2014-04-10 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S220) | ABBOTT MEDICAL | 2014-04-10 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S437) | Medtronic Cardiac Rhythm Disease Management | 2014-04-10 |
| ACTIVA PC IMPLANTABLE NEUROSTIMULATOR (P960009/S191) | Medtronic, Inc. | 2014-04-10 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S035) | Medtronic | 2014-04-10 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S002) | W. L. Gore & Associates, Inc. | 2014-04-10 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSEM (P060033/S090) | Medtronic, Inc. | 2014-04-09 |
| PARADYM RF CRT-D9750 (P060027/S060) | MicroPort CRM USA, Inc. | 2014-04-09 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LVAS (P060040/S034) | ABBOTT MEDICAL | 2014-04-09 |
| REPLY SR, REPLY DR, ESPIRIT SR, ESPIRIT DR (P950029/S088) | MicroPort CRM USA, Inc. | 2014-04-09 |
| INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S016) | Ventana Medical Systems, Inc. | 2014-04-09 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S037) | Medtronic Vascular | 2014-04-09 |
| GYNECARE THERMACHOICE UTERINE BALLON THERAPY SYSTEM (P970021/S041) | Gynecare, Inc. | 2014-04-09 |
| PATHWAY ANTI-HER-2/NEU (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S027) | Ventana Medical Systems, Inc. | 2014-04-09 |
| GELFOAM (ABSORBLE GELTON)STERILE SPONGE (N18286/S026) | Pfizer, Inc. | 2014-04-09 |
| LINX REGLUX MANAGEMENT SYSTEM (P100049/S008) | Torax Medical | 2014-04-09 |
| SURESCAN MRI IMPLANTABLE NEUROSTIMULATORS (P840001/S264) | Medtronic Neuromodulation | 2014-04-09 |
| PARADYM VR 8750, PARADYM DR 8750, PARADYM RF CRT-D (P980049/S093) | MicroPort CRM USA, Inc. | 2014-04-09 |
| HELISTAT ABSORABABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR (P850010/S044) | Integra LifeSciences Corporation | 2014-04-08 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR (P810006/S046) | Integra LifeSciences Corporation | 2014-04-08 |
| ESTEEM SYSTEM (P090018/S025) | Envoy Medical Corporation | 2014-04-08 |
| MULTI-LINK ULTRA RX AND OTW CORONARY STENT SYSTEM (P970020/S079) | Abbott Vascular, Inc. | 2014-04-07 |
| COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY (P840062/S033) | Integra Lifesciences Corp. | 2014-04-07 |
| ENLITE SENSOR (P120010/S017) | Medtronic, Inc. | 2014-04-07 |
| INTEGRA DERMAL REGENERATION TEMPLATE, INTEGRA MESHED DERMAL REGENERATION TEMPLATE (P900033/S033) | Integra Lifesciences Corp. | 2014-04-07 |
| HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT (P850010/S045) | Integra LifeSciences Corporation | 2014-04-04 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S434) | Medtronic Cardiac Rhythm Disease Management | 2014-04-04 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S041) | Roche Molecular Systems, Inc. | 2014-04-04 |
| DBS EXTENSIONS (P960009/S190) | Medtronic, Inc. | 2014-04-04 |
| BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D (P010031/S431) | Medtronic Cardiac Rhythm Disease Management | 2014-04-04 |
| COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE & MICROFIBRILLAR FORM (P810006/S047) | Integra LifeSciences Corporation | 2014-04-04 |
| BLAZER II, BLAZER II HTD, BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS (P920047/S067) | Boston Scientific Corp | 2014-04-04 |
| NEUROPACE RNS SYSTEM (P100026/S014) | NeuroPace, Inc. | 2014-04-04 |
| BLAZER II XP,BLAZER PRIME XP, INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S055) | Boston Scientific | 2014-04-04 |
| ATTAIN STARFIX LEAD (P060039/S058) | Medtronic, Inc. | 2014-04-04 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 (P060030/S041) | Roche Molecular Systems, Inc. | 2014-04-04 |
| 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 ICD (P980016/S470) | Medtronic Cardiac Rhythm Disease Management | 2014-04-04 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.0 (P000012/S048) | Roche Molecular Systems, Inc. | 2014-04-04 |
| ASSURITY, ASSURITY+ AND ENDURITY FAMILIES OF PACEMAKER DEVICES (P880086/S240) | ABBOTT MEDICAL | 2014-04-04 |
| COLLACOTE COLLATAPE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY (P840062/S034) | Integra Lifesciences Corp. | 2014-04-04 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S235) | Medtronic, Inc. | 2014-04-04 |
| TRIPOLE 16 AND TRIPOLE 16C LEADS, EXCLAIM LEADS, LAMITRODE 4, LAMITRODE 44, LAMITRODE 44C LEADS, LAMITRODE 88 LEAD (P010032/S077) | ABBOTT MEDICAL | 2014-04-04 |
| COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST (P110037/S014) | Roche Molecular Systems, Inc. | 2014-04-04 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S041) | Medtronic | 2014-04-04 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S473) | Medtronic Cardiac Rhythm Disease Management | 2014-04-04 |
| REVO MRI IPG (P090013/S135) | Medtronic, Inc. | 2014-04-04 |
| SCS EXTENSIONS, HINGED 2X4 SURGICAL LEAD, SPECIFY LEAD (P840001/S263) | Medtronic Neuromodulation | 2014-04-04 |
| ALLURE AND ALLURE QUADRA FAMILIES OF CRT-P DEVICES (P030035/S118) | ABBOTT MEDICAL | 2014-04-04 |