| SCULPTRA AND SCULPTRA AESTHETIC (P030050/S021) | Q-Med AB | 2014-04-29 |
| THINPREP IMAGING SYSTEM (P020002/S007) | Hologic, Inc. | 2014-04-29 |
| CAMERON HEALTH SUBSUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S031) | Boston Scientific Corporation | 2014-04-29 |
| CERVISTA HPV 16/18 (P080015/S009) | Hologic, Inc. | 2014-04-29 |
| VISCOAT, DUOVISC,DISCOVISC (P840064/S056) | Alcon Laboratories | 2014-04-29 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S044) | Vistakon, Division of Johnson & Johnson Vision Car | 2014-04-29 |
| ADVANTIO, INGENIO, VITALIO AND FORMIO PACEMAKERS (N970003/S161) | Boston Scientific Corp | 2014-04-29 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S042) | Roche Molecular Systems, Inc. | 2014-04-28 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S042) | Roche Molecular Systems, Inc. | 2014-04-28 |
| THERAPY CATHETER (NON-IRRIGATED) (P040014/S022) | Irvine Biomedical, Inc. | 2014-04-28 |
| COLLACOTE/COLLATAPE/COLLA[LUG ABSORBABLE COLLAGEN WOUND DRESS (P840062/S038) | Integra Lifesciences Corp. | 2014-04-28 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S049) | Roche Molecular Systems, Inc. | 2014-04-28 |
| THERAPY COOL PATH DUO CATHETER (12 HOLE IRRIGATED), SAFIRE BLU DUO CATHETER(12 HOLE IRRIGATED), COOL PATH DUO ABLATION C (P110016/S011) | ABBOTT MEDICAL | 2014-04-28 |
| LIVEWIRE TC ABLATION CATHETER (NON-IRRIGATED),SAFIRE ABLATION CATHETER (NON-IRRIGATED) (P960016/S045) | St Jude Medical | 2014-04-28 |
| THERAPY DUAL 8 CATHETER (NON-IRRIGATED), THERAPY 8MM THERMISTOR ABLATION CATHERER (NON-IRRIGATED) SAFIRE TX CATHETER (NO (P040042/S027) | Irvine Biomedical,Inc.(Ibi) | 2014-04-28 |
| ACRYSOF INTRAOCULAR LENS (P930014/S069) | Alcon Laboratories, Inc. | 2014-04-28 |
| BD PREPSTAIN SYSTEM (P970018/S028) | Bd Diagnostic Systems | 2014-04-28 |
| TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM (P980040/S046) | Johnson & Johnson Surgical Vision, Inc. | 2014-04-28 |
| JUVEDERM VOLUMA XC (P110033/S006) | Allergan | 2014-04-28 |
| ACRYSOF RESTOR INTRAOCULAR LENS (P040020/S048) | Alcon Research, Ltd. | 2014-04-28 |
| THERAPY COOL PATH CATHETER(6 HOLE IRRIGATED) AND BI-DIRECTIONAL, SAFIRE BLU (6HOLE IRRIGATED) SAFIRE BLUE SP AND THERAPY (P060019/S027) | Irvine Biomedical, Inc. | 2014-04-28 |
| HELISTAT/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S051) | Integra LifeSciences Corporation | 2014-04-28 |
| COLLASTAT/INSTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P810006/S051) | Integra LifeSciences Corporation | 2014-04-28 |
| COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST (P110037/S015) | Roche Molecular Systems, Inc. | 2014-04-28 |
| ARCHITECT ANTI-HCV (P050042/S029) | Abbott Laboratories, Inc. | 2014-04-28 |
| CAMERON HEALTH SUBCUTANEOUSIMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S032) | Boston Scientific Corporation | 2014-04-28 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S047) | Hologic, Inc. | 2014-04-25 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S118) | Cochlear Americas | 2014-04-25 |
| EN VISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS (P910056/S016) | Bausch & Lomb, Inc. | 2014-04-25 |
| EON MINI IPG NEUROSTIMULATION SYSTEM (P010032/S073) | ABBOTT MEDICAL | 2014-04-25 |
| EON CTM IPG NEUROSTIMULATION SYSTEM (P010032/S076) | ABBOTT MEDICAL | 2014-04-25 |
| NUCLEUS HYBRID L24 IMPLANT SYSTEM (P130016/S001) | Cochlear Americas | 2014-04-25 |
| LCS TOTAL KNEE SYSTEM (P830055/S141) | Depuy, Inc. | 2014-04-25 |
| LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S031) | Boston Scientific Corporation | 2014-04-24 |
| ENRHYTHM MRI EMDRO1; REVO MRI RVDRO1 (P090013/S132) | Medtronic, Inc. | 2014-04-24 |
| MARQUIS DR 7274; MARQUIS VR 7230B/7230X/723E; MAXIMO DR7278; MAXIMO VR 7232 (P980016/S468) | Medtronic Cardiac Rhythm Disease Management | 2014-04-24 |
| COBAS HPV TEST (P100020/S008) | Roche Molecular Systems, Inc. | 2014-04-24 |
| SYNCHROMED II DRUG DELIVERY INFUSION SYSTEM (P860004/S204) | Medtronic, Inc. | 2014-04-24 |
| ASSURITY, ASSURITY +, AND ENDURITY OF PACEMAKER DEVICES (P880086/S241) | ABBOTT MEDICAL | 2014-04-24 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S051) | Cordis US Corporation | 2014-04-24 |
| PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S096) | Boston Scientific Corp | 2014-04-24 |
| ITREL/ RESTORE/ SYNERGY/ SCS IMPLANTABLE NEUROSTIMULATOR SYSTEM FAMILIES (P840001/S266) | Medtronic Neuromodulation | 2014-04-24 |
| RELIANCE IS-1/DF-1 LEAD FAMILY,RELIANCE 4-SITE LEAD FAMILY (P910073/S123) | Boston Scientific | 2014-04-24 |
| ACUITY SPIRAL, EASYTRAK 2, EASYTRAK 3 (P010012/S345) | Boston Scientific Corp | 2014-04-24 |
| INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM (P080025/S067) | Medtronic Neuromodulation | 2014-04-24 |
| THINPREP SLIDES (P950039/S028) | Hologic, Inc. | 2014-04-24 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S136) | Boston Scientific Corp | 2014-04-24 |
| FLEXTEND (P960006/S041) | Boston Scientific | 2014-04-24 |
| EXPRESS CORONARY STENT SYSTEM (P020009/S122) | Boston Scientific Scimed, Inc. | 2014-04-24 |
| ACUITY STEERABLE (P050046/S023) | Guidant Corp. | 2014-04-24 |
| PROMUS ELEMENT PLUS PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S081) | Boston Scientific Corp | 2014-04-24 |
| INTERSTIM/ INTERSTIM II SACRAL NERVE STIMULATION SYSTEM (P970004/S171) | Medtronic Neuromodulation | 2014-04-24 |
| VERIFLEX CORONARY STENT SYSTEM (P040016/S128) | Boston Scientific Scimed, Inc. | 2014-04-24 |
| ALLURE AND ALLURE QUADRA FAMILIES OF CRT-P DEVICES (P030035/S119) | ABBOTT MEDICAL | 2014-04-24 |
| ACTIVA/ KINETRA/ SOLETRA IMPLANTABLE DEEP BRAIN STIMULATION SYSTEM FAMILIES (P960009/S192) | Medtronic, Inc. | 2014-04-24 |
| CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S048) | Boston Scientific Corp | 2014-04-23 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S058) | Boston Scientific Corp | 2014-04-23 |
| HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S050) | Integra LifeSciences Corporation | 2014-04-23 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S035) | Bard Peripheral Vascular | 2014-04-23 |
| VIRTUOSO DR, VIRTUOSO VR, SECURA DR AND MAXIMO II DR (P980016/S398) | Medtronic Cardiac Rhythm Disease Management | 2014-04-23 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S068) | Boston Scientific Corp | 2014-04-23 |
| BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S056) | Boston Scientific | 2014-04-23 |
| OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S009) | Endologix, LLC | 2014-04-23 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S078) | Boston Scientific Corp | 2014-04-23 |
| EXOSEAL VASCULAR CLOSURE DEVICE (VCD) (P100013/S010) | Cordis US Corporation | 2014-04-23 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S043) | Bard Peripheral Vascular, Inc. | 2014-04-23 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S126) | Boston Scientific Scimed, Inc. | 2014-04-23 |
| EXPRESS 2 MONORAIL AND OVER THE WIRE (P020009/S120) | Boston Scientific Scimed, Inc. | 2014-04-23 |
| ROTABLATOR RATATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE (P900056/S135) | Boston Scientific Corp | 2014-04-23 |
| MEDTRONIC REMOTE HOME MONITOR (P890003/S268) | Medtronic, Inc. | 2014-04-23 |
| CONSULTA CRT-D, MAXIMO II CRT-D, CONCERTO 11 CRT-D, CPMCERTP CRT-D (P010031/S361) | Medtronic Cardiac Rhythm Disease Management | 2014-04-23 |
| SCULPTRA AESTHETIC (P030050/S016) | Q-Med AB | 2014-04-23 |
| XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, SV (P110019/S047) | Abbott Vascular | 2014-04-23 |
| BARD E-LUMINEXX VASCULAR STENT (P080007/S020) | Bard Peripheral Vascular, Inc. | 2014-04-23 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S093) | Boston Scientific Corp | 2014-04-23 |
| NOVASURE MODEL 10 RADIOFREQUENCY CONTROL UNIT (P010013/S051) | Hologic, Inc. | 2014-04-22 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S090) | MicroPort CRM USA, Inc. | 2014-04-21 |
| PARADYM VR 8750, PARADYM DR 8750,PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101), (P980049/S096) | MicroPort CRM USA, Inc. | 2014-04-21 |
| PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS (P030017/S193) | Boston Scientific Corp | 2014-04-21 |
| PARADYM CRT-D 8750,PARADYM RF CRT-D 9750 (ZL101),PARADYM RF CRT-D9750 (ZL102) (P060027/S063) | MicroPort CRM USA, Inc. | 2014-04-21 |
| BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA) (P100025/S005) | Meridian Bioscience, Inc. | 2014-04-18 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM (P080025/S046) | Medtronic Neuromodulation | 2014-04-18 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL (P060038/S017) | Corcym Canada Corp | 2014-04-18 |
| LCS TOTAL KNEE SYSTEM (P830055/S142) | Depuy, Inc. | 2014-04-18 |
| INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S150) | Medtronic Neuromodulation | 2014-04-18 |
| MEMORYGEL BREAST IMPLANT (P030053/S017) | Mentor Corp. | 2014-04-18 |
| INTERGRITY CORONARY STENT SYSTEMS (P030009/S076) | Medtronic, Ireland | 2014-04-17 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMINUM CORONARY STENT SYSTEM OVER THE WIRE (P100023/S092) | Boston Scientific Corp | 2014-04-17 |
| PARADYM CRT-D 8750, PARADYM RF CRT-D 9750 (P060027/S061) | MicroPort CRM USA, Inc. | 2014-04-17 |
| SOFTEC INTRAOCULAR LENSES (IOLS) (P090022/S021) | Lenstec, Inc. | 2014-04-17 |
| SPECTRANETICS LASER SHEATHS (SLS) (P960042/S048) | Spectranetics (Philips) | 2014-04-17 |
| PARADYM VR/DR, PARADYM RF VR/RF DR (P980049/S094) | MicroPort CRM USA, Inc. | 2014-04-17 |
| ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM (P110011/S007) | Medtronic, Ireland | 2014-04-17 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S038) | Edwards Lifesciences, LLC | 2014-04-17 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S192) | Boston Scientific Corp | 2014-04-17 |
| ELCA CORONARY ATHRECTOMY CATHETERS (P910001/S070) | Spectranetics Corp. | 2014-04-17 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S033) | Allergan | 2014-04-17 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S134) | Boston Scientific Corp | 2014-04-17 |
| PERCLOSE PROGLIDE/ AT AND PROSTAR XL (P960043/S088) | Abbott Vascular, Inc. | 2014-04-17 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STNET SYSTEM (P110013/S038) | Medtronic Vascular | 2014-04-17 |