| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S266) | Medtronic, Inc. | 2015-02-23 |
| REVO MRI IPG (P090013/S176) | Medtronic, Inc. | 2015-02-23 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S260) | Medtronic, Inc. | 2015-02-23 |
| DYNAGEN, INOGEN, ORIGEBN, PUNCTUA,ENERGEN, INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S342) | Boston Scientific | 2015-02-23 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S058) | Zoll Manufacturing Corporation | 2015-02-22 |
| RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEA (P840001/S292) | Medtronic Neuromodulation | 2015-02-20 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S216) | Medtronic, Inc. | 2015-02-20 |
| VENASEAL CLOSURE SYSTEM (P140018) | Medtronic Vascular, Inc. | 2015-02-20 |
| SELOX JT 45 /JT53; ST53/ST60;TILDA R45, R53,R60; SAFIO S53, S60; TILDA JT45,53, TILDA T53,60; DRUG ELUTING PERMANENT RIG (P950037/S147) | Biotronik, Inc. | 2015-02-20 |
| LINOX SMART SD60/16; SD 65/16; 65/18, 75/18; S60, S65, S75, S DX 65/15, 65/17, T65, TD 65/16, 65/18, VOLTA TA ICR60,65,7 (P980023/S064) | Biotronik, Inc. | 2015-02-20 |
| CELERITY 2D 75, 2D 85, 3D75, 3D85, PIOLOT 75,85; COROX OTW 75-UP STEROID, 85-UP, 85-BP, D75-BP (P070008/S059) | Biotronik, Inc. | 2015-02-20 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S407) | Medtronic, Inc. | 2015-02-19 |
| GORE HELEX EX SEPTAL OCCLUDER (P050006/S045) | W. L. Gore & Associates, Inc. | 2015-02-19 |
| OXFORD PARTIAL KNEE SYSTEM (P010014/S050) | Biomet Manufacturing Corp | 2015-02-19 |
| FALOPE-RING BAND APPLICATOR KITS (P870076/S016) | Gyrus Acmi, Inc. | 2015-02-19 |
| REVO MRI IPG (P090013/S170) | Medtronic, Inc. | 2015-02-19 |
| NEUROPACE RNS SYSTEM (P100026/S029) | NeuroPace, Inc. | 2015-02-19 |
| PATHWAY ANTI-HER/NEU (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S030) | Ventana Medical Systems, Inc. | 2015-02-19 |
| INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S019) | Ventana Medical Systems, Inc. | 2015-02-19 |
| RESTORE, ITREL, SYNERGY SPINAL CORD STIMULATION SYSTEMS (P840001/S291) | Medtronic Neuromodulation | 2015-02-19 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II (P980016/S520) | Medtronic Cardiac Rhythm Disease Management | 2015-02-19 |
| THERASCREEN EGFR RGQ PCR KIT (P120022/S007) | QIAGEN GmbH | 2015-02-19 |
| ENLITE GLUCOSE SENSOR (P120010/S024) | Medtronic, Inc. | 2015-02-19 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S259) | Medtronic, Inc. | 2015-02-19 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA QUAD S (P010031/S484) | Medtronic Cardiac Rhythm Disease Management | 2015-02-19 |
| ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S094) | ABBOTT MEDICAL | 2015-02-19 |
| PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S015) | Ventana Medical Systems, Inc. | 2015-02-19 |
| THERASCREEN KRAS RGQ PCR KIT (P110027/S005) | QIAGEN GmbH | 2015-02-19 |
| CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILES OF ICD DEVICES (P910023/S353) | ABBOTT MEDICAL | 2015-02-18 |
| PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILES OF CRT-D DEVICES (P030054/S282) | ABBOTT MEDICAL | 2015-02-18 |
| ACRYSOF IQ TORIC IOLS (P930014/S077) | Alcon Laboratories, Inc. | 2015-02-17 |
| TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM (P000023/S011) | Nexus CMF, LLC | 2015-02-13 |
| BOND ORACLE HER2 IHC SYSTEM (P090015/S002) | Leica Biosystems | 2015-02-13 |
| LIFE PULSE HIGH FREQUENCY VENTILATOR (P850064/S027) | Bunnell, Inc. | 2015-02-13 |
| PRECISION SPINAL CORD STIMULATOR(SCS) SYSTEM AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S210) | Boston Scientific Corp | 2015-02-13 |
| PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S161) | Medtronic Minimed | 2015-02-13 |
| TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM (P000035/S011) | Nexus CMF, LLC | 2015-02-13 |
| QIAGEN THERASCREEN KRAS RGQ PCR KIT (P110027/S004) | QIAGEN GmbH | 2015-02-13 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047/S036) | Neomend, Inc. | 2015-02-13 |
| SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S026) | Edwards Lifesciences, LLC | 2015-02-13 |
| MINIMED 530G INSULIN PUMP (P120010/S036) | Medtronic, Inc. | 2015-02-13 |
| QIAGEN THERASCREEN EGFR RGQ PCR KIT (P120022/S006) | QIAGEN GmbH | 2015-02-13 |
| AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE TREATMENT (P000053/S055) | Boston Scientific Corp | 2015-02-12 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S038) | ABBOTT MEDICAL | 2015-02-12 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S030) | Syncardia Systems, LLC | 2015-02-12 |
| PRECISION SPECTRA SYSTEM (P030017/S209) | Boston Scientific Corp | 2015-02-12 |
| PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S024) | Infusyn Therapeutics, LLC | 2015-02-12 |
| SOLESTA INJECTABLE GEL (P100014/S013) | Palette Life Sciences | 2015-02-12 |
| TRIFECTA VALVE (P100029/S019) | ABBOTT MEDICAL | 2015-02-12 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS) (P130005/S002) | Cardiovascular Systems, Inc. | 2015-02-12 |
| BIOCOR, EPIC AND EPIC SUPRA VALVE (P040021/S026) | ABBOTT MEDICAL | 2015-02-12 |
| ST. JUDE MEDICAL ADAPTER (P010032/S087) | ABBOTT MEDICAL | 2015-02-12 |
| REVO MRI IPG (P090013/S169) | Medtronic, Inc. | 2015-02-12 |
| ADAPTA, VERSA, SENSIA IPGS, ADVISA DR IPG, ADVISA DR MRI IPG (P980035/S406) | Medtronic, Inc. | 2015-02-12 |
| ATRICURE SYNERGY ABLATION SYSTEM (P100046/S006) | AtriCure, Inc. | 2015-02-12 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S519) | Medtronic Cardiac Rhythm Disease Management | 2015-02-12 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S029) | Ortho-Clinical Diagnostics, Inc. | 2015-02-12 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S483) | Medtronic Cardiac Rhythm Disease Management | 2015-02-12 |
| ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEMS. (P930029/S049) | Medtronic, Inc. | 2015-02-12 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) WITH INHIBIZONE TREATMENT (N970012/S104) | Boston Scientific Corp | 2015-02-12 |
| INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE (P900033/S041) | Integra Lifesciences Corp. | 2015-02-12 |
| NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS (P040046/S007) | Allergan | 2015-02-11 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S024) | Edwards Lifesciences, LLC | 2015-02-11 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S215) | Medtronic, Inc. | 2015-02-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S063) | Edwards Lifesciences, LLC | 2015-02-11 |
| NATRELLE SALINE FILLED BREST IMPLANTS (P990074/S029) | Allergan | 2015-02-11 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S025) | Allergan | 2015-02-11 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, WITH THERMAFIX TISSUE PROCESS, RSR PERICARDIAL AORTIC BIO (P860057/S132) | Edwards Lifesciences, LLC | 2015-02-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S050) | Edwards Lifesciences, LLC | 2015-02-11 |
| RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS (P840001/S290) | Medtronic Neuromodulation | 2015-02-11 |
| REGENT,STANDARD,MASTERS MECHANICAL HEART VALVES (P810002/S093) | ABBOTT MEDICAL | 2015-02-10 |
| IPERIA FAMILY ICD/CRT-D: IPERIA ITREVIA AND INVENTRA (P050023/S079) | Biotronik, Inc. | 2015-02-10 |
| INTERSTIM THERAPY SYSTEM (P080025/S085) | Medtronic Neuromodulation | 2015-02-10 |
| REVO MRI IPG (P090013/S166) | Medtronic, Inc. | 2015-02-10 |
| SYNCHROMED INFUSION SYSTEM (P860004/S220) | Medtronic, Inc. | 2015-02-10 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S214) | Medtronic, Inc. | 2015-02-10 |
| INTERSTIM THERAPY SYSTEM (P970004/S189) | Medtronic Neuromodulation | 2015-02-10 |
| DROMOS DR/SR RATE ADAPTIVE PACING SYSTEM (P950037/S139) | Biotronik, Inc. | 2015-02-10 |
| PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S021) | Infusyn Therapeutics, LLC | 2015-02-10 |
| RESTORE,ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEADS (P840001/S289) | Medtronic Neuromodulation | 2015-02-10 |
| CONSULTA CRT-P, SYNERA CRT-P, VIVA CRT-P (P010015/S257) | Medtronic, Inc. | 2015-02-09 |
| EVERA S DR ICD; VR ICD, EVERTA XT DR ICD; EVERA XT VR ICD, MAXIMO II ICD; PROTECTA ICD, PROTECTA XT ICD , SECURA ICD; VI (P980016/S516) | Medtronic Cardiac Rhythm Disease Management | 2015-02-09 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S029) | Boston Scientific Corp | 2015-02-09 |
| BRAVA CRT-D'S; BRAVA QUAD CRT-D'S; CONCERTO II CRT-D; CONSULTA CRT-D; MAXIMO II CRT-D; PROTECTA CRT-D; PROTECTA XT CRT (P010031/S480) | Medtronic Cardiac Rhythm Disease Management | 2015-02-09 |
| ON-X PROSTHETIC HEART VALVE (P000037/S037) | On-X Life Technologies, Inc. | 2015-02-09 |
| ADAOTA, VERSA, SENSIA IPG, ADVISSA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S405) | Medtronic, Inc. | 2015-02-07 |
| CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD (P930039/S124) | Medtronic, Inc. | 2015-02-07 |
| CAPSUREFIX MRI LEAD (P090013/S168) | Medtronic, Inc. | 2015-02-07 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D AND VIVA XT CRT-D (P010031/S481) | Medtronic Cardiac Rhythm Disease Management | 2015-02-07 |
| BRAVA CRT-D, BRAVA QUARD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA QUAD (P010031/S482) | Medtronic Cardiac Rhythm Disease Management | 2015-02-07 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA XT ICD, PROTECTA XT ICD, SECUR (P980016/S518) | Medtronic Cardiac Rhythm Disease Management | 2015-02-07 |
| REVO MRI IPG (P090013/S167) | Medtronic, Inc. | 2015-02-07 |
| SELECTSECURE LEAD (P030036/S076) | Medtronic Cardiac Rhythm Disease Management | 2015-02-07 |
| SPRINT QUATTRO LEAD, SPRINT QUATTRO LEAD (P920015/S147) | Medtronic, Inc. | 2015-02-07 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S258) | Medtronic, Inc. | 2015-02-07 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S517) | Medtronic Cardiac Rhythm Disease Management | 2015-02-07 |
| RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEA (P840001/S288) | Medtronic Neuromodulation | 2015-02-06 |
| MULTI-LINK ULTRA CORONARY STENT SYSTEMS (P970020/S081) | Abbott Vascular, Inc. | 2015-02-06 |
| SYNCHROMED INFUSION SYSTEM (P860004/S218) | Medtronic, Inc. | 2015-02-06 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S213) | Medtronic, Inc. | 2015-02-06 |