| INGENIO,ADVANTIO,VITALIO,FORMIO IMPLANTABLE PULSE GENERATORS (N970003/S164) | Boston Scientific Corp | 2014-05-23 |
| INTEGRITY RX & OTW CORONARY STENT SYSTEMS (P030009/S078) | Medtronic, Ireland | 2014-05-23 |
| WALLSTENT TIPS ENDOPROSTHESIS (P930031/S052) | Boston Scientific Corp | 2014-05-23 |
| ADAPTA,VERSA,SENSIA,IPG,ADVISA DR IPG,ADVISA DR MRI IPG,ENPULSE E1 IPG, ENPULSE E2 IPG,KAPPA D (KAPPA 700)IPG,KAPPA D (P980035/S372) | Medtronic, Inc. | 2014-05-23 |
| DYNAGEN,INOGEN,ORIGEN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) (P010012/S354) | Boston Scientific Corp | 2014-05-23 |
| THERASCREEN KRAS RGQ PCR KIT (P110027) | QIAGEN GmbH | 2014-05-23 |
| WALLSTENT ILIAC ENDOPROSTHESIS (P940019/S044) | Boston Scientific Scimed, Inc. | 2014-05-23 |
| MYCARELINK PATIENT MONITOR (P890003/S306) | Medtronic, Inc. | 2014-05-23 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD,INTRINSIC 30 ICD,INTRINSIC ICD,MARQUIS DR ICD,MARQUIS (P980016/S477) | Medtronic Cardiac Rhythm Disease Management | 2014-05-23 |
| PRECISION SPECTRA SPINAL STIMULATOR (SCS) SYSTEM (P030017/S186) | Boston Scientific Corp | 2014-05-22 |
| HYDRELLE (P050033/S017) | Anika Therapeutics, Inc. | 2014-05-22 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S005) | ABBOTT MEDICAL | 2014-05-22 |
| MEDSTREAM PROGRAMMABLE INFUSION SYSTEM (P890055/S055) | Intera Oncology | 2014-05-22 |
| ION PACLITAXEL-ELUTING PLATNIUM CHROMIUM CORONARY STENT SYSTEM (P100023/S097) | Boston Scientific Corp | 2014-05-22 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S482) | Medtronic Cardiac Rhythm Disease Management | 2014-05-22 |
| QUANTIFERON TB GOLD IN-TUBE (P010033/S024) | Qiagen | 2014-05-22 |
| PROMUS ELEMENT PLUS/ PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMS (P110010/S084) | Boston Scientific Corp | 2014-05-22 |
| PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S020) | Infusyn Therapeutics, LLC | 2014-05-22 |
| CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S444) | Medtronic Cardiac Rhythm Disease Management | 2014-05-22 |
| NEXGEN LPS-FLEX MOBILE AND LPS BEARING KNEES (P060037/S028) | Zimmer, Inc. | 2014-05-22 |
| TMJ FOSSA-EMINENCE AND CONDY LAR PROSTHESIS SYSTEM (P000023/S010) | Nexus CMF, LLC | 2014-05-21 |
| DEFLUX INJECTABLE GEL (P000029/S077) | Palette Life Sciences | 2014-05-21 |
| TMJ FOSSA-EMIENCE PROSTHESIS SYSTEM (P000035/S010) | Nexus CMF, LLC | 2014-05-21 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S046) | Edwards Lifesciences, LLC | 2014-05-20 |
| SYNVISC AND SYNVISC-ONE (P940015/S028) | Sanofi Genzyme Corp. | 2014-05-20 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S045) | Medtronic, Inc. | 2014-05-19 |
| CARPENTIER-EDWARDS PORCINE AORTIC AND MITRAL BIOPROTHESIS (P870056/S067) | Edwards Lifesciences, LLC | 2014-05-19 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOP (P860057/S121) | Edwards Lifesciences, LLC | 2014-05-19 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING, CARPENTIER-EDWARDS DURAFLEX LO (P870077/S061) | Edwards Lifesciences, LLC | 2014-05-19 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S041) | Medtronic Heart Valves | 2014-05-19 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S080) | Boston Scientific Corp | 2014-05-19 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S045) | Medtronic, Inc. | 2014-05-19 |
| COOL POINT(TM) TUBING SET (P060019/S025) | Irvine Biomedical, Inc. | 2014-05-19 |
| QUADRA ASSURA, UNIFY, UNIFY ASSURA, AND UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S266) | ABBOTT MEDICAL | 2014-05-19 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROTHESIS (P010041/S050) | Edwards Lifesciences, LLC | 2014-05-19 |
| FORTIFY AND FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S334) | ABBOTT MEDICAL | 2014-05-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S037) | Edwards Lifesciences, LLC | 2014-05-19 |
| HANCOCK LOW POROSITY VALVED CONDUIT (P870078/S025) | Medtronic, Inc. | 2014-05-19 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S049) | Zoll Manufacturing Corporation | 2014-05-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S050) | Edwards Lifesciences, LLC | 2014-05-19 |
| MOBI-C CERVICAL DISC PROTHESIS (P110009/S001) | Highridge Medical, LLC | 2014-05-19 |
| CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S021) | DePuy Orthopaedics, Inc. | 2014-05-19 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S054) | Medtronic, Inc. | 2014-05-19 |
| BALAFILCON A PRODUCT FAMILY (P980006/S015) | Bausch & Lomb, Inc. | 2014-05-16 |
| ADVIA CENTAUR HBSAGII (P110041) | Siemens Corp. | 2014-05-16 |
| EN TRUST, VIRTUSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, SECURA, VIRTUOSO II, INSYNC MARQUIS, PROTECTA DR,XT, DR, PROT (P980016/S472) | Medtronic Cardiac Rhythm Disease Management | 2014-05-16 |
| BARD ABLATION SYSTEM (P000020/S018) | Boston Scientific Corp | 2014-05-16 |
| ARCHITECT TOTAL PSA (P910007/S043) | Abbott Laboratories | 2014-05-16 |
| RF MARINR MC/SC /SCXL/ SCXS/SCXXL/, RF CONTACTR, RF CONDUCTR & RF CONDUCTR II CARDIAC ABLATION CATHETERS. (P930029/S043) | Medtronic, Inc. | 2014-05-16 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S236) | Medtronic, Inc. | 2014-05-16 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S040) | Edwards Lifesciences, LLC | 2014-05-16 |
| MAXIMO II CRT-D, CONCERTO, CONCERTO II CRT-D, CONSULTA, INSYNC II & IIIMARQUIS, MAXIMO, SENTRY, MARQUIS INSYNC II PROTEC (P010031/S433) | Medtronic Cardiac Rhythm Disease Management | 2014-05-16 |
| NUCLEUS CI500 SERIES COCHLEAR IMPLANT SYSTEM (P970051/S119) | Cochlear Americas | 2014-05-16 |
| ADVISA, ENRHYTHRM MRI (P980035/S369) | Medtronic, Inc. | 2014-05-16 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S053) | Edwards Lifesciences, LLC | 2014-05-16 |
| REVEAL DX. REVEAL XT, REVEAL LINQ INSERTABLE CARDIAC MONITOR (P890003/S305) | Medtronic, Inc. | 2014-05-16 |
| ARCHITECT FREE PSA (P980007/S034) | Abbott Laboratories | 2014-05-16 |
| REVO MRI (P090013/S136) | Medtronic, Inc. | 2014-05-16 |
| ADVANTIO, INGENIO PG FAMILIES (N970003/S160) | Boston Scientific Corp | 2014-05-15 |
| ATTAIN ABILITY MODEL 4X96 LEAD (P080006/S063) | Medtronic, Inc. | 2014-05-15 |
| INVIVE CRT-P FAMILY (P030005/S107) | Guidant Corp. | 2014-05-15 |
| MARGINPROBE SYSTEM (P110014/S002) | Dilon Medical Technologies, Ltd. | 2014-05-15 |
| ADVISA DR IPG, ADVISA DR MRI IPG (P980035/S375) | Medtronic, Inc. | 2014-05-15 |
| COGNIS CRT-D FAMILY (P010012/S349) | Boston Scientific Corp | 2014-05-15 |
| TELIGEN,INCEPTA,PUNCTUA,ENERGEN ICDS, INCEPTA, PUNCTUA,ENERGEN CRT-DS (P960040/S312) | Boston Scientific | 2014-05-15 |
| REVO MRI IPG (P090013/S140) | Medtronic, Inc. | 2014-05-15 |
| ENDURANT AND ENDURANT II STENT GRAFT SYSTEM (P100021/S036) | Medtronic Vascular | 2014-05-14 |
| CRYOCONSOLE (P020045/S053) | Medtronic Cryocath, LP | 2014-05-14 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S025) | Boston Scientific Corp | 2014-05-14 |
| SILSOFT (CLASTOFILCON A) CONTACT L ENS (P850068/S010) | Bausch & Lomb, Inc. | 2014-05-14 |
| PARADIGM REAL TIME INSULIN PUMPS, PARADIGM REAL TIME REVEL INSULINPUMPS, GUARDIAN REAL TIME MONITOR. (P980022/S155) | Medtronic Minimed | 2014-05-14 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S055) | Hologic, Inc. | 2014-05-14 |
| ENLITE SENSOR (P120010/S022) | Medtronic, Inc. | 2014-05-14 |
| SYNVISC (P940015/S032) | Sanofi Genzyme Corp. | 2014-05-14 |
| EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S474) | Medtronic Cardiac Rhythm Disease Management | 2014-05-13 |
| ARCHITECT FREE PSA (P980007/S035) | Abbott Laboratories | 2014-05-13 |
| MULTI-LINK ULTRA CORONARY STENT SYSTEMS, MULTI-LINK ZETA CORONARY STENT SYSTEM (P970020/S080) | Abbott Vascular, Inc. | 2014-05-13 |
| CRYSTALENS AND TRULIGN TORIC INTRAOCULAR LENS (IOLS) (P030002/S031) | Bausch & Lomb, Inc. | 2014-05-13 |
| BRAVA CRT-D,VIVA S CRT-D, VIVA XT CRT-D (P010031/S435) | Medtronic Cardiac Rhythm Disease Management | 2014-05-13 |
| XIENCE PRIME/XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S067) | Abbott Vascular | 2014-05-13 |
| ZIMMER NEXGEN LPS FLEX MOBILE AND LPS MOBILE BEARING KNEE (P060037/S027) | Zimmer, Inc. | 2014-05-13 |
| MULTI-LINK VISION CORONARY STENT SYSTEMS, MULTI-LINK MINI VISION CORONARY STENT SYSTEMS, MULTI-LINK 8 CONONARY STENT (P020047/S058) | Abbott Vascular | 2014-05-13 |
| ENDURANT AND ENDURANT II STENT GRAFT SYSTEM (P100021/S035) | Medtronic Vascular | 2014-05-13 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDFIAL AORTIC BIOPROSTHESIS (P860057/S124) | Edwards Lifesciences, LLC | 2014-05-13 |
| OMNILINK ELITE VACULAR SYSTEM (P110043/S006) | Abbott Vascular-Cardiac Therapies | 2014-05-13 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S123) | Abbott Vascular, Inc. | 2014-05-13 |
| NIRXCELL COCR CORONARY SENT ON RX (P110004/S003) | Medinol, Ltd. | 2014-05-12 |
| INVIVE AND INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKERS (CRT-P) (P010012/S351) | Boston Scientific Corp | 2014-05-12 |
| DIGENE HC2 STSTEM SOFTWARE (P890064/S030) | Qiagen Gaithersburg, Inc. | 2014-05-12 |
| ADVANTIO, INGENIO, VITALIO AND FORMIO IMPLANTABLE PULSE GENERATOR (PG) (N970003/S162) | Boston Scientific Corp | 2014-05-12 |
| CORDIS SMART CONTROL NITINOL STENT SYSTEM (P020036/S028) | Cordis US Corporation | 2014-05-12 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S082) | Boston Scientific Corp | 2014-05-12 |
| CORDIS SMART CONTROL VASCULAR STENT SYSTEMS (P120002/S003) | Cordis US Corporation | 2014-05-12 |
| SOLESTA (P100014/S012) | Palette Life Sciences | 2014-05-12 |
| SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE) (P050050/S007) | Djo Global | 2014-05-09 |
| THERAKOS CELLEX PHOTOPHERESIS KIT (P860003/S075) | Therakos Development Limited | 2014-05-09 |
| BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM (P850022/S022) | Ahp Eos Buyer, Inc. | 2014-05-09 |
| SINOVIAL (SODIUM HYALURONATE 0.8%) (P110005) | Ibsa Institut Biochimique SA | 2014-05-09 |
| BIOMET EBI BONE HEALING SYSTEM (P790002/S032) | Ahp Eos Buyer, Inc. | 2014-05-09 |
| VNS THERAPY SYSTEM (P970003/S166) | LivaNova USA, Inc. | 2014-05-09 |