| ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S053) | Alcon Research, Ltd. | 2013-12-30 |
| ENVISTA IOL (P910056/S015) | Bausch & Lomb, Inc. | 2013-12-30 |
| ACRYSOF INTRAOCULAR LENSES (P930014/S072) | Alcon Laboratories, Inc. | 2013-12-30 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S007) | Torax Medical | 2013-12-27 |
| LCS TOTAL KNEE SYSTEM (P830055/S140) | Depuy, Inc. | 2013-12-26 |
| MINILINK REAL-TIME SYSTEM (P980022/S119) | Medtronic Minimed | 2013-12-26 |
| ATTAIN ABILITY LEAD (P080006/S052) | Medtronic, Inc. | 2013-12-24 |
| ATTAIN STARFIX LEAD (P060039/S044) | Medtronic, Inc. | 2013-12-24 |
| ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA MRI IPG,RELIA IPG (P980035/S319) | Medtronic, Inc. | 2013-12-24 |
| CAPSURE SP NOVUS LEAD,CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD,IMPULSE II LEAD (P850089/S095) | Medtronic Cardiac Rhythm Disease Management | 2013-12-24 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S038) | Baxter Healthcare Corp | 2013-12-24 |
| SELECT SECURE LEAD (P030036/S056) | Medtronic Cardiac Rhythm Disease Management | 2013-12-24 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S021) | Syncardia Systems, LLC | 2013-12-24 |
| TRANSVENE LEAD (P980050/S081) | Medtronic, Inc. | 2013-12-24 |
| TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S017) | Cerenovus, Inc. | 2013-12-24 |
| CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, VITATRON CRYSTALLINE LEAD (P930039/S085) | Medtronic, Inc. | 2013-12-24 |
| PARADIGM REAL-TIME INSULIN PUMPS (P980022/S149) | Medtronic Minimed | 2013-12-24 |
| EPICARDIAL PATCH LEAD (P900061/S120) | Medtronic Cardiac Rhythm Disease Management | 2013-12-24 |
| CAPSURE LEAD (P890003/S272) | Medtronic, Inc. | 2013-12-24 |
| MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRTUOSO II DR/VR IC (P980016/S412) | Medtronic Cardiac Rhythm Disease Management | 2013-12-24 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S048) | Medtronic, Inc. | 2013-12-24 |
| CAPSURE LEAD,CAPSURE SP LEAD,VITATRON CRYSTALINE LEAD,VITATRON EXCELLENCE PS+LEAD (P830061/S089) | Medtronic Cardiac Rhythm Disease Management | 2013-12-24 |
| CAPSUREFIX MRI LEAD, REVO MRI IPG (P090013/S091) | Medtronic, Inc. | 2013-12-24 |
| ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P, LEFT VENTRICULAR PACING LEAD, SYNCRA CRT-P (P010015/S197) | Medtronic, Inc. | 2013-12-24 |
| SPRINT QUATTRO LEAD,SUBCUTANEOUS LEAD,TRANSVENE SVC LEAD (P920015/S109) | Medtronic, Inc. | 2013-12-24 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D,& XT CRT-D, BRAVA CRT-D, VIVA S CRT-D (P010031/S372) | Medtronic Cardiac Rhythm Disease Management | 2013-12-24 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S103) | Advanced Bionics | 2013-12-24 |
| PUNCTUA, ENERGEN, INCEPTA, AND TELIGEN ICD (P960040/S297) | Boston Scientific | 2013-12-23 |
| SPRINT QUATTRO LEAD (P920015/S126) | Medtronic, Inc. | 2013-12-23 |
| PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (V619IMUD) (P970055/S013) | Diasorin | 2013-12-23 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S014) | Natus Medical Incorporated | 2013-12-23 |
| VITATRON CRYSTALLINE LEAD (P930039/S100) | Medtronic, Inc. | 2013-12-23 |
| CAPSURE LEAD (P890003/S296) | Medtronic, Inc. | 2013-12-23 |
| ARTEGRAFT BOVINE HETEROGRAFT (N16837/S011) | LeMaitre Vascular, Inc. | 2013-12-23 |
| EPICARDIAL PATCH LEAD (P900061/S125) | Medtronic Cardiac Rhythm Disease Management | 2013-12-23 |
| PUNCTUA, ENERGEN INCEPTA COGNIS (P010012/S332) | Boston Scientific Corp | 2013-12-23 |
| VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S010) | Siemens Healthcare Diagnostics, Inc. | 2013-12-23 |
| PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY (P970054/S010) | Diasorin | 2013-12-23 |
| NEUROPACE RNS SYSTEM (P100026/S002) | NeuroPace, Inc. | 2013-12-20 |
| INTRODUCTION CP900 SERIES RECHARGEABLE BATTERIES (A29 AND A30) (P970051/S112) | Cochlear Americas | 2013-12-20 |
| PROMUS ELEMENT PLUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S063) | Boston Scientific Corp | 2013-12-20 |
| ELECSYS ANTI-HBC TEST SYSTEM (P100031/S008) | Roche Diagnostics Corp. | 2013-12-20 |
| OMNILINK ELITE VASCULAR BALLON-EXPANDABEL STENT SYSTEM (P110043/S004) | Abbott Vascular-Cardiac Therapies | 2013-12-20 |
| RADIESSE (P050052/S048) | Merz North America, Inc. | 2013-12-20 |
| WALLSTENT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S050) | Boston Scientific Corp | 2013-12-20 |
| WALLSTENT (VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S039) | Boston Scientific Corporation | 2013-12-20 |
| COAPTITE 1.0CC (P040047/S032) | Merz North America, Inc. | 2013-12-20 |
| PATHVYSION HER-2 DNA PROBE KIT (P980024/S012) | Abbott Molecular, Inc. | 2013-12-20 |
| LIFEVEST DEVICE (P010030/S045) | Zoll Manufacturing Corporation | 2013-12-20 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S112) | Boston Scientific Scimed, Inc. | 2013-12-20 |
| UROVYSION BLADDER CANCER KIT (P030052/S014) | Abbott Molecular | 2013-12-20 |
| LIFEVEST® WEARABLE DEFIBRILLATOR (P010030/S046) | Zoll Manufacturing Corporation | 2013-12-20 |
| ELECSYS ANTI-HBC IGM TEST SYSTEM (P110022/S008) | Roche Diagnostics Corp. | 2013-12-20 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S020) | Medtronic | 2013-12-20 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S051) | Boston Scientific Corp | 2013-12-20 |
| WALLSTENT ILIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S042) | Boston Scientific Scimed, Inc. | 2013-12-20 |
| RADIESSE (P050037/S045) | Merz North America, Inc. | 2013-12-20 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S118) | Boston Scientific Scimed, Inc. | 2013-12-20 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYTEM (P100023/S081) | Boston Scientific Corp | 2013-12-20 |
| XIENCE PRIME EVERLIMUS CORONARY STENT SYSTEM (P110019/S050) | Abbott Vascular | 2013-12-19 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROTHESIS (P000007/S044) | Edwards Lifesciences, LLC | 2013-12-19 |
| NIRXCELL COCR CORONARY STENT ON RX SYSTEM (P110004/S001) | Medinol, Ltd. | 2013-12-19 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC AND MITRAL BIOPROSTHESES DEVICE FAMILIES (P860057/S115) | Edwards Lifesciences, LLC | 2013-12-19 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S006) | Torax Medical | 2013-12-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S033) | Edwards Lifesciences, LLC | 2013-12-19 |
| RESOLUTE INTEGRITY RX ZOTAROLIMUS-ELUTING CORNARY STENT SYSTEM; RESOLUTE INTEGRITY OTW ZOTAROLINUS ELUTING STENT SYSTEM (P110013/S031) | Medtronic Vascular | 2013-12-19 |
| ELECSYS ANTI-HBC TEST SYSTEM (P100032/S007) | Roche Diagnostics Corp. | 2013-12-19 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING,CARPENTIER-EDWARDS DURAFLEX LOW (P870077/S057) | Edwards Lifesciences, LLC | 2013-12-19 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROTHESIS (P010041/S046) | Edwards Lifesciences, LLC | 2013-12-19 |
| VIBRANT SOUNDBRIDGE SYSTEM (P990052/S023) | Med-El Elektromedizinische Gerate GmbH | 2013-12-19 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S058) | Thoratec Laboratories Corp. | 2013-12-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S046) | Edwards Lifesciences, LLC | 2013-12-19 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS,PORCINE VALVED CONDUIT (P870056/S063) | Edwards Lifesciences, LLC | 2013-12-19 |
| REGENT, STANDARD AND MASTERS MECHANICAL HEART VALVE (P810002/S088) | ABBOTT MEDICAL | 2013-12-19 |
| INTEGRITY RX CORONARY STENT SYSTEM; INTEGRITY OTW CORONARY STENT SYSTEM (P030009/S072) | Medtronic, Ireland | 2013-12-19 |
| WALLSTENT SYSTEM (10 MM VENOUS ENDOPROSTHESIS) AND UNISTEP PLUS DELIVERY SYSTEM (12 MM VENOUS ENDOPROSTHESIS) (P980033/S040) | Boston Scientific Corporation | 2013-12-18 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE WIRE SYSTEMS) (P100023/S082) | Boston Scientific Corp | 2013-12-18 |
| TECNIS 1-PIECE IOL TEDNIS OPTIBLUE 1-PIECE IOL, TECNIS MULTIFOCAL 1-PIECE IOL (P980040/S047) | Johnson & Johnson Surgical Vision, Inc. | 2013-12-18 |
| CORONARY FLEXTOME CUTTING BALLOON (P950020/S066) | Boston Scientific Corp | 2013-12-18 |
| ARCTIC FRONT CARDIAC CRYOABLATION SYSTEM, ARCTIC FRONT ADVANCE CARDUAC CRYIABKATUIB CATHETER, CRYOCONSOLE AND ACCESSORIE (P100010/S032) | Medtronic Cryocath, LP | 2013-12-18 |
| BLAZER II, BLAZER II HTD,BLAZER PRIME HTD (P920047/S064) | Boston Scientific Corp | 2013-12-18 |
| WALLSTENT TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S051) | Boston Scientific Corp | 2013-12-18 |
| EPIC VACULAR SELF EXPANDING STENT SYSTEM (P110035/S024) | Boston Scientific Corp | 2013-12-18 |
| MOBI-C CERVICAL DISC PROSTHESIS (P110002/S003) | Highridge Medical, LLC | 2013-12-18 |
| WALLSTENT LILAC ENDOPROSTHESIS (P940019/S043) | Boston Scientific Scimed, Inc. | 2013-12-18 |
| EXPRESS2 MONORAIL AND OTW CORONARY STENT SYSTEM (P020009/S113) | Boston Scientific Scimed, Inc. | 2013-12-18 |
| THERAPY COOL FLEX ABLATION CATHETER (P110016/S008) | ABBOTT MEDICAL | 2013-12-18 |
| MOBI-C CERVICAL DISC PROTHESIS (P110009/S003) | Highridge Medical, LLC | 2013-12-18 |
| COAPTITE 1.0CC (P040047/S031) | Merz North America, Inc. | 2013-12-18 |
| OXFORD PARTIAL KNEE SYSTEM (P010014/S047) | Biomet Manufacturing Corp | 2013-12-18 |
| SIENTRA SILICONE GEL BREAST IMPLANTS (P070004/S006) | Tiger Aesthetics Medical, LLC | 2013-12-18 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S064) | Boston Scientific Corp | 2013-12-18 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S119) | Boston Scientific Scimed, Inc. | 2013-12-18 |
| NEUROPACE RNS SYSTEM (P100026/S001) | NeuroPace, Inc. | 2013-12-18 |
| BLAZER II XP,BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS (P020025/S051) | Boston Scientific | 2013-12-18 |
| TECNIS MULTIFOCAL 3-PIECE IOL (P080010/S010) | Johnson & Johnson Surgical Vision, Inc. | 2013-12-18 |
| THORATEC VENTRICULAR ASSIST DEVICE(VAD) (P870072/S057) | Thoratec Laboratories Corp. | 2013-12-18 |
| ATTTAIN ABILITY (P080006/S062) | Medtronic, Inc. | 2013-12-18 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S052) | Boston Scientific Corp | 2013-12-18 |
| ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S051) | Alcon Research, Ltd. | 2013-12-18 |