| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S058) | Edwards Lifesciences, LLC | 2014-10-02 |
| STAR EXCIMER LASER SYSTEM (P990010/S007) | Amo Manufacturing USA, LLC | 2014-10-02 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S044) | Edwards Lifesciences, LLC | 2014-10-02 |
| STAR EXCIMER LASER SYSTEM (P930016/S043) | Amo Manufacturing USA, LLC | 2014-10-02 |
| PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS (P030017/S203) | Boston Scientific Corp | 2014-10-02 |
| STAR EXCIMER LASER SYSTEM (P910062/S007) | Amo Manufacturing USA, LLC | 2014-10-02 |
| RESURE SEALANT (P130004/S001) | Ocular Therapeutix, Inc. | 2014-10-02 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S503) | Medtronic Cardiac Rhythm Disease Management | 2014-10-02 |
| ENLITE GLUCOSE SENSORS (P120010/S034) | Medtronic, Inc. | 2014-10-02 |
| VAISALA CONTINUOUS MONITORING SYSTEM (P920015/S141) | Medtronic, Inc. | 2014-10-02 |
| ATTAIN PERFORMA MODEL 4298 LEAD (P080006/S074) | Medtronic, Inc. | 2014-10-02 |
| MINILINK REAL-TIME TRANSMITTER (P120010/S023) | Medtronic, Inc. | 2014-10-02 |
| ENLITE GLUCOSE SENSORS (P120010/S035) | Medtronic, Inc. | 2014-10-02 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S018) | OraSure Technologies, Inc. | 2014-10-02 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S011) | Edwards Lifesciences, LLC | 2014-10-02 |
| CONCERTO II CRT-D, CONCULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S467) | Medtronic Cardiac Rhythm Disease Management | 2014-10-02 |
| MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S014) | Mentor Corp. | 2014-10-01 |
| FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CARDIAC C (P020045/S062) | Medtronic Cryocath, LP | 2014-10-01 |
| CRYOCONSOLE (P020045/S059) | Medtronic Cryocath, LP | 2014-10-01 |
| FREEZOR MAX CARDIAC CRYOABLATION CATHETER, ARCTIC FRONT ADVANCED CRYOBALLOON CATHETER (P100010/S044) | Medtronic Cryocath, LP | 2014-10-01 |
| EDWARDS NOVAFLEX+ DELIVERY SYSTEM (P130009/S009) | Edwards Lifesciences, LLC | 2014-09-30 |
| OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM (P110043/S009) | Abbott Vascular-Cardiac Therapies | 2014-09-30 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S006) | Bolton Medical, Inc. | 2014-09-30 |
| VITATRON BRILLIANT S+ VDD LEAD (P890003/S318) | Medtronic, Inc. | 2014-09-30 |
| OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S010) | Endologix, LLC | 2014-09-30 |
| TRIFECTA VALVE (P100029/S017) | ABBOTT MEDICAL | 2014-09-30 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S105) | Boston Scientific Corp | 2014-09-29 |
| MINIMED 530G SYSTEM (P120010/S032) | Medtronic, Inc. | 2014-09-29 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S029) | Syncardia Systems, LLC | 2014-09-29 |
| SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S010) | Edwards Lifesciences, LLC | 2014-09-29 |
| PROCOL VASCULAR BIOPROSTHESIS (P020049/S003) | LeMaitre Vascular, Inc. | 2014-09-29 |
| OPTUNE (P100034/S010) | Novocure, GmbH | 2014-09-28 |
| XIENCE XPEDITION/ XIENCE XPEDITION SV/ XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S069) | Abbott Vascular | 2014-09-26 |
| THINPREP PROCESSORS (P950039/S030) | Hologic, Inc. | 2014-09-26 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S003) | Cardiovascular Systems, Inc. | 2014-09-26 |
| SUPARTZ (P980044/S019) | Seikagaku Corp. | 2014-09-26 |
| MINILINK REAL-TIME SYSTEM,IPRO RECORDER CGMS SYSTEM,IPRO2 RECORDER CGM SYSTEM (P980022/S143) | Medtronic Minimed | 2014-09-25 |
| DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE (P000021/S026) | Siemens Healthcare Diagnostics | 2014-09-25 |
| ARCTIC FRONT, ARCTIC FRONT ADVANCED, AND FREEZOR MAX CARDIAC CRYOABLATION CATHETERS (P100010/S043) | Medtronic Cryocath, LP | 2014-09-25 |
| FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICES, FREEZOR MAX SURGICAL CRYOABLATION DEVICES (P020045/S061) | Medtronic Cryocath, LP | 2014-09-25 |
| ABBOTT REAL TIME HCV GENOTYPE II (P120012/S004) | Abbott Molecular | 2014-09-25 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S394) | Medtronic, Inc. | 2014-09-25 |
| MINILINK REAL-TIME TRANSMITTER (P120010/S003) | Medtronic, Inc. | 2014-09-25 |
| DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE (P020027/S021) | Siemens Healthcare Diagnostics | 2014-09-25 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S250) | Medtronic, Inc. | 2014-09-25 |
| CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S115) | Medtronic Cardiac Rhythm Disease Management | 2014-09-24 |
| MARGINPROBE SYSTEM (P110014/S003) | Dilon Medical Technologies, Ltd. | 2014-09-24 |
| SURGICEL FAMILY OF HEMOSTATS (N12159/S033) | ETHICON, Inc. | 2014-09-24 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG RELIA IPG (P980035/S393) | Medtronic, Inc. | 2014-09-24 |
| ATTAIN STARFIX LEAD (P060039/S063) | Medtronic, Inc. | 2014-09-24 |
| RF CONTACTR, RF ENHANCR II, RF MARINR, RF MARINR UNIPOLAR, RF CONDUCTR CATHETERS (P930029/S046) | Medtronic, Inc. | 2014-09-24 |
| EVERA S DR/VR, EVERA XT DR/VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA , VIRUOSO II DR/VR ICD'S (P980016/S501) | Medtronic Cardiac Rhythm Disease Management | 2014-09-24 |
| MODEL 5348 SINGLE CHAMBER TEMPORARY PACEMAKER, MODEL 5388 DUAL CHAMBER TEMPORARY PACEMAKER (P820003/S131) | Medtronic Cardiac Rhythm Disease Management | 2014-09-24 |
| SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD (P920015/S140) | Medtronic, Inc. | 2014-09-24 |
| CAPSUREFIX MRI LEAD, REVO MRI IPG (P090013/S156) | Medtronic, Inc. | 2014-09-24 |
| CAPSUREFIX NOVUS LEAD (P930039/S117) | Medtronic, Inc. | 2014-09-24 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S031) | Medtimo, Inc. | 2014-09-24 |
| HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S054) | Integra LifeSciences Corporation | 2014-09-24 |
| CAPSUREFIX MRI LEAD (P090013/S155) | Medtronic, Inc. | 2014-09-24 |
| EPICARDIAL PATCH LEAD (P900061/S131) | Medtronic Cardiac Rhythm Disease Management | 2014-09-24 |
| ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LEAD, CONSULTA CRT-P, SYNCRA CRT-P AND VIVA CRT-P (P010015/S249) | Medtronic, Inc. | 2014-09-24 |
| COLLACOTE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND (P840062/S041) | Integra Lifesciences Corp. | 2014-09-24 |
| ATTAIN ABILITY LEAD, ATTAIN PERFORMA QUADRIPOLAR LEAD (P080006/S072) | Medtronic, Inc. | 2014-09-24 |
| SELECTSECURE LEAD (P030036/S074) | Medtronic Cardiac Rhythm Disease Management | 2014-09-24 |
| CAPSURE VDD2, CARELINK PROGRAMMER (P890003/S321) | Medtronic, Inc. | 2014-09-24 |
| ARISTA AH ABSORBABLE HEMOSTAT AND FLEXTIP APPLICATORS (P050038/S022) | Davol, Inc. | 2014-09-24 |
| TRANSVENE CS/SVC LEAD (P980050/S096) | Medtronic, Inc. | 2014-09-24 |
| CAPSUREFIX LEAD,CAPSUREFIX NOVUS LEAD,SUREFIX LEAD,VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, TORQUE CLIP DEVICE-ACCESSO (P930039/S118) | Medtronic, Inc. | 2014-09-24 |
| CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD (P850089/S111) | Medtronic Cardiac Rhythm Disease Management | 2014-09-24 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE (P810006/S054) | Integra LifeSciences Corporation | 2014-09-24 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, MAXIMO II CRT-D, PROTECTA XT CRT-D, VIVA QUAD S CRT-D, PROTECTA XT CRT (P010031/S465) | Medtronic Cardiac Rhythm Disease Management | 2014-09-24 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S063) | Medtronic, Inc. | 2014-09-24 |
| XIENCE V AND NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S107) | Abbott Vascular, Inc. | 2014-09-23 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411 (P090007/S012) | Roche Diagnostics Corp. | 2014-09-19 |
| INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S003) | Inspire Medical Systems | 2014-09-19 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601 AND COBAS E 602 (P090008/S014) | Roche Diagnostics Corp. | 2014-09-19 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S060) | W. L. Gore & Associates, Inc. | 2014-09-19 |
| SPF XL IIB IMPLANTABLE SPINAL FUSION STIMULATORS (P850035/S038) | Ahp Eos Buyer, Inc. | 2014-09-19 |
| NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE- FILLED BREAST IMPLANTS (P040046/S005) | Allergan | 2014-09-19 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E 170 (P090009/S012) | Roche Diagnostics Corp. | 2014-09-19 |
| EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS (P790005/S051) | Ahp Eos Buyer, Inc. | 2014-09-19 |
| ATTAIN ABILITY LEAD (P080006/S071) | Medtronic, Inc. | 2014-09-18 |
| THINPREP IMAGING SYSTEM (P020002/S008) | Hologic, Inc. | 2014-09-18 |
| INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, INOGEN AND ORIGEN ICD'S (P960040/S331) | Boston Scientific | 2014-09-18 |
| INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, INOGEN AND ORIGEN CRT-DS (P010012/S370) | Boston Scientific Corp | 2014-09-18 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S026) | Boston Scientific Corp | 2014-09-17 |
| PROMUS ELEMENT PLUS & PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM STENT SYSTEMS (P110010/S090) | Boston Scientific Corp | 2014-09-17 |
| VOLTA(1CR/2CR/CT/2CT) ICD LEAD, PROTEGO (S/SD/T/TD) ICD LEAD,KAINOX VCS 60 ICD LEADLINOX SMART (S/SD/T/TD/S DX) ICD LEAD (P980023/S060) | Biotronik, Inc. | 2014-09-16 |
| MACROPLASTIQUE IMPLANTS (P040050/S011) | Uroplasty, LLC | 2014-09-16 |
| CELERITY 2D/3D/PILOT STEROID-ELUTING LV LEAD, COROX (-S/-L) BP STEROID-ELUTING LV LEAD (P070008/S054) | Biotronik, Inc. | 2014-09-16 |
| DEXTRUS, SELOX ST/JT, SETROX S, AND TILDA T/JT/R STEROID-ELUTING PACING LEADS; SOLOX SLX -BP PACING LEAD (P950037/S138) | Biotronik, Inc. | 2014-09-16 |
| GENESIS IPG, EON IPG, EON C IPG, EON MINI IPG, PROTEGE IPG (P010032/S081) | ABBOTT MEDICAL | 2014-09-16 |
| DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY (P960009/S204) | Medtronic, Inc. | 2014-09-15 |
| SCS NEUROSTIMULATORS IMPLANTABLE RESTORE FAMILY (P840001/S281) | Medtronic Neuromodulation | 2014-09-15 |
| PROMUS ELEMENT PLUS PLATINUM CHROMIUM EVEROLIMUS-ELUTING CORONARY STENT SYSTEM & PROMUS PREMIER EVEROLIMUS-ELUTING PLATI (P110010/S092) | Boston Scientific Corp | 2014-09-12 |
| FRONTIER/ FRONTIER II / ANTHEM FAMILY OF CRT-P'S (P030035/S123) | ABBOTT MEDICAL | 2014-09-12 |
| IMPLANTABLE MINIATURE TELESCOPE (P050034/S014) | Samsara Vision, Inc. | 2014-09-12 |
| AFFINITY, INTEGRITY, VICTORY, ZEPHYR, & ACCENT FAMILY OF PACEMAKERS (P880086/S245) | ABBOTT MEDICAL | 2014-09-12 |
| THIN PREP PROCESSORS (P950039/S029) | Hologic, Inc. | 2014-09-12 |
| MEDTRONIC SYNCHROMED II INFUSION SYSTEMS (P860004/S211) | Medtronic, Inc. | 2014-09-12 |