| ENDOTAK RELIANCE G/SG with 4-SITE Connector Defibrillation Leads, Passive Fixation Lead Models: 0265, 0266, 0282, 0283 (P910073/S134) | Boston Scientific | 2016-04-27 |
| FREEDOM SOLO STENTLESS HEART VALVE (P130011/S004) | Corcym Canada Corp | 2016-04-27 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM 13 (P070015/S132) | Abbott Vascular, Inc. | 2016-04-27 |
| XIENCE PRIME,XIENCE XPEDITION, XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S080) | Abbott Vascular | 2016-04-27 |
| BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S097) | ABBOTT MEDICAL | 2016-04-27 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S021) | Cryolife, Inc. | 2016-04-27 |
| PERCEVAL SUTURELESS HEART VALVE (P150011/S003) | Corcym S.r.l. | 2016-04-27 |
| BRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S, VIVA QUAD XT, VIVA S, VIVA XT C (P010031/S546) | Medtronic Cardiac Rhythm Disease Management | 2016-04-26 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS) (P050039/S017) | Exactech, Inc. | 2016-04-26 |
| IMAGE CHECKER, IMAGE CHECKER LICENSE (P970058/S027) | Hologic, Inc. | 2016-04-26 |
| VISIA AF VR, VISIA AF MRI VR SURESCAN, EVERA S DR ICD, EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, P (P980016/S585) | Medtronic Cardiac Rhythm Disease Management | 2016-04-26 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S011) | Bolton Medical, Inc. | 2016-04-26 |
| ANGIOSCULPT SCORING BALLOON CATHETER (P050018/S021) | Spectranetics Corp. | 2016-04-26 |
| FLUENCY PLUS ENDOVASCULAR STENT GRAFT (P130029/S002) | Bard Peripheral Vascular, Inc. | 2016-04-26 |
| OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S054) | Biomet Manufacturing Corp | 2016-04-26 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S072) | Zoll Manufacturing Corporation | 2016-04-26 |
| CARELINK INSTRUMENT COMMAND LIBRARY, MEDTRONIC CARELINK MONITOR, MYCARELINK PATIENT MONITOR. (P890003/S353) | Medtronic, Inc. | 2016-04-26 |
| IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012) | Boston Scientific | 2016-04-25 |
| COBAS KRAS MUTATION TEST (P140023/S003) | Roche Molecular Systems, Inc. | 2016-04-25 |
| BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS (P030031/S073) | Biosense Webster, Inc. | 2016-04-25 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S080) | Terumo Medical Corporation | 2016-04-25 |
| IDEAL IMPLANT SALINE FILLED BREAST IMPLANT (P120011/S002) | Bimini Health Tech | 2016-04-25 |
| NAVISTAR DS CATHETER, EZ Steer Nav DS Bi-Directional Catheter (P010068/S050) | Biosense Webster, Inc. | 2016-04-25 |
| THERMOCOOL SMART TOUCH UNI-DIRECTIONAL NAVIGATION CATHETER (P040036/S054) | Biosense Webster, Inc. | 2016-04-25 |
| EZ Steer DS Bi-Directional Catheter,EZ Steer Bi-Directional CatheterABLATION, Celsius Flutter Bi-Directional Catheter (P950005/S060) | Biosense Webster, Inc. | 2016-04-25 |
| NAVI-STAR and EZ Steer Nav Bi-Directional Catheter (P990025/S048) | Biosense Webster, Inc. | 2016-04-25 |
| TRIFECTA VALVE WITH GLIDE TECHNOLOGY (P100029/S021) | ABBOTT MEDICAL | 2016-04-24 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S533) | Medtronic Cardiac Rhythm Disease Management | 2016-04-22 |
| Verity 5056, 5156, 5256, 5356, 5456, 5816; Zephyr 5826, 5626; Identity 5286, 5386; Sustain XL PM1134, PM1136, PM2134, PM (P880086/S271) | ABBOTT MEDICAL | 2016-04-22 |
| Amplia MRI CRT-D DTMB1D4; Amplia MRI Quad CRT-D DTMB1QQ; Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ (P010031/S544) | Medtronic Cardiac Rhythm Disease Management | 2016-04-22 |
| VALIANT THORACIC STENT GRAFT WITH CAPTIVA DELIVERY SYSTEM (P100040/S025) | Medtronic Vascular | 2016-04-22 |
| Revo MRI SureScan IPG RVDR01 (P090013/S224) | Medtronic, Inc. | 2016-04-22 |
| TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM (P070027/S044) | Medtronic Vascular | 2016-04-22 |
| Adapta, Versa, Sensia IPG ADDR01, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, ADSR01, ADVDD01; (P980035/S461) | Medtronic, Inc. | 2016-04-22 |
| Consulta CRT-P C4TR01; Syncra CRT-P C2TR01; Viva CRT-P C6TR01 (P010015/S298) | Medtronic, Inc. | 2016-04-22 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S084) | W. L. Gore & Associates, Inc. | 2016-04-22 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S572) | Medtronic Cardiac Rhythm Disease Management | 2016-04-22 |
| Evera MRI ICD DDMB1D4, DDMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1; Evera XT DR ICD DDBB1D1, DDBB1D (P980016/S583) | Medtronic Cardiac Rhythm Disease Management | 2016-04-22 |
| ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER (P980037/S057) | Boston Scientific Corp | 2016-04-22 |
| UVAR PHOTOPHERESIS SYSTEM (P860003/S085) | Therakos Development Limited | 2016-04-22 |
| MINIMED 530G SYSTEM (P120010/S087) | Medtronic, Inc. | 2016-04-21 |
| PARADIGM REAL-TIME REVEL SYSTEM (P150019/S011) | Medtronic Minimed | 2016-04-21 |
| PARADIGM REAL-TIME REVEL SYSTEM (P150019/S012) | Medtronic Minimed | 2016-04-21 |
| CURRENT+ ELLIPSE, FORTIFY ASSURA FAMILIES OF THE ICD DEVICES (P910023/S370) | ABBOTT MEDICAL | 2016-04-21 |
| CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S191) | Medtronic Minimed | 2016-04-21 |
| ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS (P840001/S321) | Medtronic Neuromodulation | 2016-04-21 |
| ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER (P020012/S012) | Tiger Aesthetics Medical, LLC | 2016-04-21 |
| MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM (P960009/S246) | Medtronic, Inc. | 2016-04-21 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S210) | Medtronic Neuromodulation | 2016-04-21 |
| MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM (P080025/S105) | Medtronic Neuromodulation | 2016-04-21 |
| DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM (P120005/S046) | Dexcom, Inc. | 2016-04-21 |
| MINIMED 530G SYSTEM (P120010/S086) | Medtronic, Inc. | 2016-04-21 |
| MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM (P860004/S246) | Medtronic, Inc. | 2016-04-21 |
| PROMOTE+ QUADRA ASSURA , UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S301) | ABBOTT MEDICAL | 2016-04-21 |
| GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S114) | ABBOTT MEDICAL | 2016-04-20 |
| COLOGUARD (P130017/S007) | Exact Sciences Corporation | 2016-04-20 |
| CORDIS PRECISE NITINOL STENT SYSTEM (P030047/S032) | Cordis US Corporation | 2016-04-20 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) (P110023/S018) | Medtronic Vascular, Inc. | 2016-04-20 |
| BRIO NEUROSTIMULATION SYSTEM (P140009/S013) | ABBOTT MEDICAL | 2016-04-20 |
| VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S367) | Boston Scientific | 2016-04-20 |
| ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV (P100017/S015) | Abbott Molecular, Inc. | 2016-04-20 |
| ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG) (P120012/S011) | Abbott Molecular | 2016-04-20 |
| S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036/S036) | Cordis US Corporation | 2016-04-20 |
| SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS (P120002/S012) | Cordis US Corporation | 2016-04-20 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S413) | Boston Scientific Corp | 2016-04-20 |
| IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S016) | Medtronic, Inc. | 2016-04-19 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S019) | Boston Scientific Corp | 2016-04-19 |
| PROMUS PREMIER EVEROLIMUS-ELUTING PLANTINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S118) | Boston Scientific Corp | 2016-04-19 |
| LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2). (P910018/S019) | Kaneka Pharma America Corp. | 2016-04-19 |
| AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM (P950009/S020) | Bd Diagnostics | 2016-04-19 |
| EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM (P020025/S086) | Boston Scientific | 2016-04-19 |
| BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S073) | Boston Scientific Corp | 2016-04-19 |
| CapSureFix Novus Lead 5076; Vitatron Crystalline (P930039/S150) | Medtronic, Inc. | 2016-04-18 |
| SYNCARDIA CAMPANION 2 DRIVER SYSTEM (P030011/S039) | Syncardia Systems, LLC | 2016-04-15 |
| MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES (P990075/S036) | Mentor Worldwide, LLC | 2016-04-15 |
| 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,CRT-D MRI AMPLIA,CRT-D MRI (P010031/S530) | Medtronic Cardiac Rhythm Disease Management | 2016-04-15 |
| SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022/S004) | Nevro Corporation | 2016-04-15 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S084) | Abbott Vascular | 2016-04-15 |
| MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS (P030053/S033) | Mentor Corp. | 2016-04-15 |
| PROGEL PLEURAL AIR LEAK SEALANT WITH RECOMBINANT HUMAN ALBUMIN (P010047/S032) | Neomend, Inc. | 2016-04-15 |
| EVERA MRI ICD,EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,VISIA AF VR,VISIA AF S VR,VISIA AF MRI VR SU (P980016/S569) | Medtronic Cardiac Rhythm Disease Management | 2016-04-15 |
| digene Hybrid Capture 2 (HC2) HPV DNA Test and digene Hybrid Capture 2 (HC2) High Risk (P890064/S033) | Qiagen Gaithersburg, Inc. | 2016-04-15 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S083) | Abbott Vascular | 2016-04-15 |
| NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022/S006) | Nevro Corporation | 2016-04-15 |
| RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S064) | Medtronic Vascular | 2016-04-14 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD (P080006/S091) | Medtronic, Inc. | 2016-04-14 |
| THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR (P110016/S031) | ABBOTT MEDICAL | 2016-04-14 |
| Dynagen, Inogen, Origen Implantable Cardiac Defibrillators (ICDs) (P960040/S368) | Boston Scientific | 2016-04-14 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S017) | Cook Ireland, Ltd. | 2016-04-14 |
| Dynagen, Inogen, Origen Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) (P010012/S414) | Boston Scientific Corp | 2016-04-14 |
| LCS(R) TOTAL KNEE SYSTEM (P830055/S169) | Depuy, Inc. | 2016-04-14 |
| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH (P960042/S053) | Spectranetics (Philips) | 2016-04-13 |
| ACROS DR/SR/SLR/D/S,AXIOS DR/SR/SLR/D/S,BA03 DDDR,CYLOS DR/DR-T/VR,DROMOS DR/SR/SL,KAIROS DR/SR/SL/D/S,PHILOS DR/DR-T/S (P950037/S160) | Biotronik, Inc. | 2016-04-13 |
| VENTANA PATHWAY ANTI-C-KIT PRIMARY ANTIBODY (POLYCLONAL) (P020055/S018) | Ventana Medical Systems, Inc. | 2016-04-13 |
| ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM (P140030/S002) | Biotronik AG | 2016-04-13 |
| INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S024) | Ventana Medical Systems, Inc. | 2016-04-13 |
| DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS (P030009/S085) | Medtronic, Ireland | 2016-04-13 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S580) | Medtronic Cardiac Rhythm Disease Management | 2016-04-13 |
| IFORIA 5/7 DR-T/VR-T/VR-T DX; INVENTRA 7 DR-T/VR-T/VR-T DX; IPERIA 5/7 DR-T/VR-T/VR-T DX; LUMAX 300/340 DR/DR-T/VR/VR-T (P050023/S093) | Biotronik, Inc. | 2016-04-13 |
| VENTANA ALK (D5F3) CDX ASSAY (P140025/S002) | Ventana Medical Systems, Inc. | 2016-04-13 |