| COAPTITE INJECTABLE IMPLANT (P040047/S027) | Merz North America, Inc. | 2013-07-23 |
| VITATRON C20 SR IPG , C60 DR IPG, T20 SR IPG, VITATRON T60 DR IPG (P990001/S112) | Medtronic, Inc. | 2013-07-23 |
| ACRYSOF RESTOR APODIZED DIFFRACTIVE IOLS (P040020/S045) | Alcon Research, Ltd. | 2013-07-23 |
| Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR POT PIN PLUG, HV SPLITTER/ADAPTOR KIT, IS-I CONNECTOR PORT PIN PLUG KIT, (P920015/S113) | Medtronic, Inc. | 2013-07-23 |
| CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD (P850089/S098) | Medtronic Cardiac Rhythm Disease Management | 2013-07-23 |
| PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S017) | Ventana Medical Systems, Inc. | 2013-07-23 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S050) | Medtronic, Inc. | 2013-07-23 |
| ADHESIVE, CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELENCE PS+LEAD (P830061/S093) | Medtronic Cardiac Rhythm Disease Management | 2013-07-23 |
| PMMA SINGLE-PIECE POSTERIOR CHAMBER IOLS (P840060/S039) | Alcon Laboratories | 2013-07-23 |
| ADAPTA, VERSA, SENSIA IPG (P980035/S327) | Medtronic, Inc. | 2013-07-23 |
| ATTAIN ABILITY LEAD (P080006/S054) | Medtronic, Inc. | 2013-07-23 |
| PMMA ANTERIOR CHAMBER IOLS (P880087/S021) | Alcon Laboratories | 2013-07-23 |
| CELSIUS CATHETER, CELSIUS RMT CATHETER, EZ STEER DS CATHETER, DEFLECTABLE DIAGNOSTIC/ABLATION (P950005/S042) | Biosense Webster, Inc. | 2013-07-22 |
| NAVISTAR CATHETER, NAVISTAR RMT CATHETER, EZ STEER NAY CATHETER, BIOSENSE WEBSTER CABLES (P990025/S035) | Biosense Webster, Inc. | 2013-07-22 |
| EDWARDS SAPIEN TRANSCATETER HEART VALVE AN TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S020) | Edwards Lifesciences, LLC | 2013-07-22 |
| NAVISTAR THERMOCOOL CATHETER, NAVISTAR RMT THERMOCOOL CATHETER, EZ STEER (P040036/S033) | Biosense Webster, Inc. | 2013-07-22 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S042) | Zoll Manufacturing Corporation | 2013-07-22 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S034) | Edwards Lifesciences, LLC | 2013-07-22 |
| CELSIUS DS CATHETER, NAVISTAR DS CATHETER, NAVISTAR RMT DS CATHETER, EZ STEER NAY DS (P010068/S032) | Biosense Webster, Inc. | 2013-07-22 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S045) | Cordis US Corporation | 2013-07-22 |
| BLAZER II TEMPERATURE ABLATION CATHETER, BLAZER II XP TEMPERATURE ABLATION CATHETER, BLAZER PRIME HTD TEMPERATURE ABLATI (P920047/S058) | Boston Scientific Corp | 2013-07-22 |
| CELSIUS THERMOCOOL CATHETER, CELSIUS RMT THERMOCOOL CATHETER, CELSIUS RMT THERMOCOOL (P030031/S050) | Biosense Webster, Inc. | 2013-07-22 |
| ONYX LIQUID EMBOLIC SYSTEM (LES) (P030004/S007) | Ev3 Neurovascular | 2013-07-19 |
| ZILVER PTX DRUG ELUTING PERIPHERAL STENT (P100022/S006) | Cook Ireland, Ltd. | 2013-07-19 |
| GENESYS HTA SYSTEM (P000040/S030) | Axora Medical, Inc. | 2013-07-19 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S171) | Boston Scientific Corp | 2013-07-19 |
| WALLSTENT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S046) | Boston Scientific Corp | 2013-07-18 |
| AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE (P110032/S005) | Lombard Medical Limited | 2013-07-18 |
| ARCHITECT AUSAB (P050051/S021) | Abbott Laboratories, Inc. | 2013-07-18 |
| LIVEWARE TC ABLATION CATHETER (P960016/S042) | St Jude Medical | 2013-07-18 |
| CAROTID WALLSTENT MONORAIL (P050019/S016) | Boston Scientific Corp | 2013-07-18 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S025) | Boston Scientific Corporation | 2013-07-18 |
| ARCHITECT HBSAG/HBSAG CONFIRMATORY (P060007/S027) | Abbott Laboratories | 2013-07-18 |
| WALLSTENT (VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S035) | Boston Scientific Corporation | 2013-07-18 |
| TOTAL KNEE SYSTEM (P830055/S135) | Depuy, Inc. | 2013-07-17 |
| INTERSECTENT PROPEL MINI SINUS IMPLANT (P100044/S008) | Intersect Ent. | 2013-07-17 |
| DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S008) | DePuy Orthopaedics, Inc. | 2013-07-17 |
| PUREVISION (BALAFILCON A) VISIBILLITY TINTED CONTACT LENS,PUREVISION TORIC (BALAFILCON A) VISIBILITY TINTED CONTACT LEN (P980006/S021) | Bausch & Lomb, Inc. | 2013-07-17 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S035) | W. L. Gore & Associates, Inc. | 2013-07-17 |
| SMARTABLATE SYSTEM-SMARTABLATE IRRIGATION PUMP KIT (P990071/S023) | Biosense Webster, Inc. | 2013-07-17 |
| ADAPTA, VERSA, SENSIA IPG (P980035/S326) | Medtronic, Inc. | 2013-07-17 |
| RADIESSE DERMAL FILLER (P050037/S038) | Merz North America, Inc. | 2013-07-16 |
| RADIESSE DERMAL FILLER (P050052/S041) | Merz North America, Inc. | 2013-07-16 |
| RELIANCE IS-1/DF-1,RELIANCE 4-SITE PASSIVE FIXATION LEADS (P910073/S118) | Boston Scientific | 2013-07-16 |
| ADVISA DR IPG,ADVISA DR MRI IPG (P980035/S336) | Medtronic, Inc. | 2013-07-16 |
| BELOTERO BALANCE DERMAL FILLER (P090016/S007) | Merz North America, Inc. | 2013-07-16 |
| CARPENTIER-EDWARDS BIOSPROSTHETIC PULMONIC VALVED CONDUIT (P870056/S060) | Edwards Lifesciences, LLC | 2013-07-16 |
| ALERE NMP22 TEST (P940035/S010) | Abbott Diagnostics Scarborough, Inc. | 2013-07-16 |
| BIOFINITY XR (P080011/S024) | CooperVision, Inc. | 2013-07-16 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S056) | Thoratec Laboratories Corp. | 2013-07-16 |
| CONSULTA CRT-P,SYNCRA CRT-P (P010015/S206) | Medtronic, Inc. | 2013-07-16 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S201) | Medtronic, Inc. | 2013-07-15 |
| CARELINK MONITORS, CARELINK EXPRESS MONITIORS, CARDIOSIGHT READERS, REVEAL DX, REVEAL XT (P890003/S277) | Medtronic, Inc. | 2013-07-15 |
| APTIMA HPV ASSAY (P100042/S001) | Gen-Probe Incorporated | 2013-07-15 |
| CONSULTA CRT D,MAXIMO II CRT-D,CONCERTO II CRT-D,CONCERTO CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA XT CRT-D,VIVA S (P010031/S376) | Medtronic Cardiac Rhythm Disease Management | 2013-07-15 |
| XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S043) | Abbott Vascular | 2013-07-15 |
| HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S041) | CooperSurgical, Inc. | 2013-07-15 |
| VIRTUOSO DR,VIRTUOSO VR,SECURA DR, MAXIMO II DR,VIRTUOSO II DR,SECURA VR,MAXIMO II VR,VIRTUOSO II VR,PROTECTA XT DR (P980016/S416) | Medtronic Cardiac Rhythm Disease Management | 2013-07-15 |
| SILIKON 1000 (P950008/S010) | Alcon | 2013-07-15 |
| ADVISA, ENRHYTHM MRI (P980035/S325) | Medtronic, Inc. | 2013-07-15 |
| PROMUS ELEMENT PLUS EVEROLIMUS PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S050) | Boston Scientific Corp | 2013-07-15 |
| REVO MRI (P090013/S098) | Medtronic, Inc. | 2013-07-15 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S170) | Boston Scientific Corp | 2013-07-12 |
| EONC 16-CHANNEL IPG NEUROSTIMULATION SYSTEM (P010032/S072) | ABBOTT MEDICAL | 2013-07-12 |
| SUPARTZ (P980044/S015) | Seikagaku Corp. | 2013-07-12 |
| THERASCREEN EGFR RGQ PCR KIT (P120022) | QIAGEN GmbH | 2013-07-12 |
| RENAMIC (P950037/S124) | Biotronik, Inc. | 2013-07-12 |
| PRESTIGE CERVICAL DISC (P060018/S003) | Medtronic Sofamor Danek, Inc. | 2013-07-12 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICDO) SYSTEM (P110042/S010) | Boston Scientific Corporation | 2013-07-12 |
| LIFESTENT VASCULAR STENT SYSTEMS (P070014/S039) | Bard Peripheral Vascular, Inc. | 2013-07-12 |
| TRANSCATHER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S019) | Edwards Lifesciences, LLC | 2013-07-11 |
| APLIGRAF (P950032/S072) | Organogenesis, Inc. | 2013-07-11 |
| TRANSCATHER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S033) | Edwards Lifesciences, LLC | 2013-07-11 |
| GORE TAG THORACIC AAA ENDOPROSTHESIS (P040043/S054) | W. L. Gore & Associates, Inc. | 2013-07-11 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S169) | Boston Scientific Corp | 2013-07-11 |
| GORE EXCUDER AAA EDOPROSTHESIS (P020004/S083) | W. L. Gore & Associates, Inc. | 2013-07-11 |
| NATRELLE SILICONE FILLED BREAST IMPLANTS (P020056/S022) | Allergan | 2013-07-10 |
| NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS (P040046/S004) | Allergan | 2013-07-10 |
| NATRELLE SALINE FILLED BREAST IMPLANT (P990074/S027) | Allergan | 2013-07-10 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S055) | W. L. Gore & Associates, Inc. | 2013-07-10 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S077) | Medtronic, Inc. | 2013-07-10 |
| AKREOS INTRAOCULAR LENSES (IOLS) (P060022/S017) | Bausch & Lomb, Inc. | 2013-07-10 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S084) | W. L. Gore & Associates, Inc. | 2013-07-10 |
| VNS THERAPY GENERATOR (DEMIPULSE) (ASPIREHC) (P970003/S162) | LivaNova USA, Inc. | 2013-07-10 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S014) | Medtronic Vascular | 2013-07-10 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM, & WITH SURESOUND ULTRINE SOUND, NOVASURE RF CONTROLLER 115V (P010013/S046) | Hologic, Inc. | 2013-07-10 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S002) | Bolton Medical, Inc. | 2013-07-10 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM. (P900056/S124) | Boston Scientific Corp | 2013-07-10 |
| ISERT MODEL 251 PRELOADED POSTERIOR CHAMBER IOL LEVEL B MODIFICATION OF PARENT IOL (P080004/S011) | Hoya Surgical Optics, Inc. | 2013-07-10 |
| WALLSTENT RP ENDOPROSTHESIS LLIAC (P940019/S039) | Boston Scientific Scimed, Inc. | 2013-07-09 |
| WALLSTENT RP ENDOPROSTHESIS TIPS (P930031/S045) | Boston Scientific Corp | 2013-07-09 |
| EXPRESS MONORAIL AND OTW CORONARY STENT SYSTEM (P020009/S108) | Boston Scientific Scimed, Inc. | 2013-07-09 |
| CORONARY FLEXTOME CUTTING BALLON (P950020/S063) | Boston Scientific Corp | 2013-07-09 |
| EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S024) | Boston Scientific Corporation | 2013-07-09 |
| PERFLUORON OCULAR ENDOTAMPONADE (P950018/S016) | Alcon Laboratories | 2013-07-09 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S015) | Boston Scientific Corp | 2013-07-09 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S055) | Boston Scientific Corp | 2013-07-09 |
| WALLSTENT RP ENDOPROSTHESIS VENOUS (P980033/S034) | Boston Scientific Corporation | 2013-07-09 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S047) | Boston Scientific Corp | 2013-07-09 |
| ION (TAXUS ELEMENT CORONARY STENT SYSTEM (P100023/S074) | Boston Scientific Corp | 2013-07-09 |