| ESSURE SYSTEM (P020014/S043) | Bayer Pharma AG | 2015-06-09 |
| ENLITE GLUCOSE SENSOR (P120010/S058) | Medtronic, Inc. | 2015-06-09 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S053) | Medtronic | 2015-06-09 |
| ACCESS HYBRITECH FREE PSA REAGENT ASSAY (P970038/S030) | Beckman Coulter, Inc. | 2015-06-09 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S013) | Cook Ireland, Ltd. | 2015-06-08 |
| RESTORE, ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATIONS LEA (P840001/S301) | Medtronic Neuromodulation | 2015-06-08 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S227) | Medtronic, Inc. | 2015-06-08 |
| CAPSUREFIX NOVUS LEAD, CAPSUREFIX NOVUS LEAD AND CAPSUREFIX NOVUS MRI SURESCAN LEAD, VITATRON CRYSTALLINE ACTIVE FIXATIO (P930039/S131) | Medtronic, Inc. | 2015-06-06 |
| NEUROPACE RNS SYSTEM (P100026/S035) | NeuroPace, Inc. | 2015-06-05 |
| THXID BRAF KIT (P120014/S005) | bioMerieux, Inc. | 2015-06-05 |
| APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S003) | Gen-Probe Incorporated | 2015-06-05 |
| LCS TOTAL KNEE SYSTEM (P830055/S157) | Depuy, Inc. | 2015-06-05 |
| APTIMA HPV ASSAY (P100042/S004) | Gen-Probe Incorporated | 2015-06-05 |
| ACTIVITRAX II IPG, ACTIVITRAX IPG, LEGEND II IPG,LEGEND IPG,MICRO MINIX,MINIX,MINIXST IPGS,PREMIER IPG,PREVAIL IPG, VITA (P850051/S083) | Medtronic, Inc. | 2015-06-04 |
| MEDTRONIC PCD, TACHYARRHYTHMIA CONTROL SYSTEM (P920015/S152) | Medtronic, Inc. | 2015-06-04 |
| APPLICATION SOFTWARE, MEDTRONIC GEM ICD, MEDTRONIC JEWEL ICD, MEDTRONIC JEWEL PLUS ICD, MEDTRONIC MICRO JEWEL ICD,MEDTRO (P900061/S134) | Medtronic Cardiac Rhythm Disease Management | 2015-06-04 |
| APPLICATION SOFTWARE AND JEWEL AF ICD (P980050/S099) | Medtronic, Inc. | 2015-06-04 |
| APPLICATION SOFTWARE, CONSULTA CRT-P, INSYNC IPG, SYNCRA CRT-P AND VIVA CRT-P (P010015/S271) | Medtronic, Inc. | 2015-06-04 |
| VNS THERAPY SYSTEM (P970003/S174) | LivaNova USA, Inc. | 2015-06-04 |
| LEGEND PLUS IPG (P930022/S018) | Medtronic, Inc. | 2015-06-04 |
| APPLICATION SOFTWARE, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD,EVERA XT VR ICD,GEM DR ICD,GEM II DR ICD,GEM I (P980016/S537) | Medtronic Cardiac Rhythm Disease Management | 2015-06-04 |
| APPLICATION SOFTWARE, PROVIT SOFTWARE, VITATRON C20 SR IPG, VITATRON C60 DR IPG, VITATRON T20 SR IPG, VITATRON T60 DR (P990001/S120) | Medtronic, Inc. | 2015-06-04 |
| APPLICATION SOFTWARE, BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC ICD, INSYNC (P010031/S500) | Medtronic Cardiac Rhythm Disease Management | 2015-06-04 |
| SURGICEL FAMILY OF ABSORBABLE HEMOSTATS (N12159/S034) | ETHICON, Inc. | 2015-06-04 |
| ORIGEN EL ICD, ORIGEN MINI ICD, DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, INCEPTA ICD, ENERGEN I (P960040/S346) | Boston Scientific | 2015-06-04 |
| THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (P060040/S042) | ABBOTT MEDICAL | 2015-06-04 |
| APPLICATION SOFTWARE, KAPPA 400 DR IPG AND KAPPA 400 SR IPG (P970012/S097) | Medtronic, Inc. | 2015-06-04 |
| THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (P870072/S060) | Thoratec Laboratories Corp. | 2015-06-04 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S076) | Terumo Medical Corporation | 2015-06-04 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG, APPLICATION SOFTWARE,AT500 DDDRP PACING (P980035/S421) | Medtronic, Inc. | 2015-06-04 |
| RADIESSE INJECTABLE IMPLANT (P050052/S049) | Merz North America, Inc. | 2015-06-04 |
| SYMBIOS IPG AND SYNERGYST IPG (P820003/S134) | Medtronic Cardiac Rhythm Disease Management | 2015-06-04 |
| DYNAGEN CRT-D, DYNAGEN X4 CRT-D,INOGEN CRT-D, INOGEN X4 CRT-D,ORIGEN CRT-D, ORIGEN X4 CRT-D, INCEPTA TM ICD,ENERGEN TM I (P010012/S388) | Boston Scientific Corp | 2015-06-04 |
| APPLICATION SOFTWARE, REVO MRI IPG AND SOFTWARE (P090013/S184) | Medtronic, Inc. | 2015-06-04 |
| CARELINK® MONITOR (P890003/S330) | Medtronic, Inc. | 2015-06-04 |
| THORATEC HEARTMATE II LVAS (P060040/S041) | ABBOTT MEDICAL | 2015-06-03 |
| NATRELLE INSPIRA BREAST IMPLANTS (P020056/S031) | Allergan | 2015-06-03 |
| RADIESSE (+) 0.8CC, RADIESSE (+) 1.5CC (P050052/S066) | Merz North America, Inc. | 2015-06-03 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S043) | W. L. Gore & Associates, Inc. | 2015-06-03 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S035) | Dexcom, Inc. | 2015-06-03 |
| CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS THERMO-COOL ELECTROPHYSIOLOGY CATHETER (P030031/S068) | Biosense Webster, Inc. | 2015-06-02 |
| CATHETER, PERCUTANEOUS, CARDIAC ABLATION NAVISTAR ELECTROPHYSIOLOGY CATHETER (P990025/S046) | Biosense Webster, Inc. | 2015-06-02 |
| MAESTRO RECHARGEABLE SYSTEM (P130019/S001) | Reshape Lifesciences, Inc. | 2015-06-02 |
| WAVELIGHT EX500 LASER SYSTEM (P020050/S021) | Alcon Laboratories, Inc. | 2015-06-02 |
| WAVELIGHT EX500 LASER SYSTEM (P030008/S019) | Alcon Laboratories, Inc. | 2015-06-02 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S018) | W. L. Gore & Associates, Inc. | 2015-06-02 |
| DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE (WITH PROVISC IN LATEX-FREE PACKAGING CONFIGURATION ONLY) (P890047/S046) | Alcon Research, Ltd. | 2015-06-02 |
| PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM-OTW (P110010/S105) | Boston Scientific Corp | 2015-06-02 |
| VISCOAT & PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (LATEX-FREE PACKAGING CONFIGURATION ONLY FOR PROVISC) (P840064/S060) | Alcon Laboratories | 2015-06-02 |
| THINPREP IMAGING SYSTEM (P020002/S010) | Hologic, Inc. | 2015-06-02 |
| CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS ELECTROPHYSIOLOGY CATHETER, (P950005/S057) | Biosense Webster, Inc. | 2015-06-02 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S079) | W. L. Gore & Associates, Inc. | 2015-06-02 |
| TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS (P030002/S034) | Bausch & Lomb, Inc. | 2015-06-02 |
| CATHETER, PERCUTANEOUS, CARDIAC ABLATION NAVISTAR DS ELECTROPHYSIOLOGY CATHETER (P010068/S047) | Biosense Webster, Inc. | 2015-06-02 |
| PROMUS ELEMENT PLUS AND PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMINUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE- (P110010/S096) | Boston Scientific Corp | 2015-06-01 |
| WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE TECHNOLOGY (P130013/S002) | Boston Scientific Corp | 2015-06-01 |
| IMPLANTABLE PULSE GENERATOR (PG), ESSENTIO, PROPONENT, ACCOLADE, ALTRUA2 (N970003/S176) | Boston Scientific Corp | 2015-05-31 |
| CARDIAC RESYNCHRONIZATION THERAPY -PACEMAKER (CRT P) VALITUDE: U125 AND U128 (P030005/S123) | Guidant Corp. | 2015-05-31 |
| VNS THERAPY ASPIRESR (P970003/S173) | LivaNova USA, Inc. | 2015-05-29 |
| PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS (P030017/S226) | Boston Scientific Corp | 2015-05-29 |
| BLAZER II TEMPERATURE ABLATION CATHETER, BLAZER II HTD TEMPERATURE ABLATION CATHETER (P920047/S080) | Boston Scientific Corp | 2015-05-29 |
| CERVISTA HPV 16/18 ASSAY (P080015/S012) | Hologic, Inc. | 2015-05-29 |
| DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TESTS (P890064/S032) | Qiagen Gaithersburg, Inc. | 2015-05-29 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S061) | Zoll Manufacturing Corporation | 2015-05-29 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S115) | Boston Scientific Corp | 2015-05-28 |
| CORDIS SMART AND SMART CONTROL VASCULAR STENT SYSTEMS (P120002/S010) | Cordis US Corporation | 2015-05-28 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P130030/S012) | Boston Scientific Corp | 2015-05-28 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE (P900056/S146) | Boston Scientific Corp | 2015-05-28 |
| CORDIS SMART AND SMART CONTROL NITINOL STENT SYSTEMS VARIOUS (P020036/S034) | Cordis US Corporation | 2015-05-28 |
| LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S039) | Alcon Laboratories, Inc. | 2015-05-28 |
| BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S071) | Boston Scientific | 2015-05-28 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM/PROMUS PREMIER EVEROLIMUS-ELUTING CHROMIUM CORONARY STENT SYSTEM (P110010/S106) | Boston Scientific Corp | 2015-05-28 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S067) | Boston Scientific Corp | 2015-05-28 |
| CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S059) | Boston Scientific Corp | 2015-05-28 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S081) | Boston Scientific Corp | 2015-05-28 |
| CORDIS PRECISE NITINOL STENT SYSTEMS (P030047/S031) | Cordis US Corporation | 2015-05-28 |
| LUMAX DR-T, LUMAX VR-T AND LUMAX CRT-D (P050023/S086) | Biotronik, Inc. | 2015-05-27 |
| ADVISA DR IPG, ADVISA SR MRI IPG AND ADVISA DR MRI IPG (P980035/S420) | Medtronic, Inc. | 2015-05-27 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S042) | W. L. Gore & Associates, Inc. | 2015-05-27 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S114) | W. L. Gore & Associates, Inc. | 2015-05-27 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S115) | W. L. Gore & Associates, Inc. | 2015-05-27 |
| CONSULTA CRT-P, SYNCRA CRT-P AND VIVA CRT-P (P010015/S270) | Medtronic, Inc. | 2015-05-27 |
| THXID BRAF KIT (P120014/S003) | bioMerieux, Inc. | 2015-05-27 |
| PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR SYSTEMS (P030017/S216) | Boston Scientific Corp | 2015-05-27 |
| ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S033) | Medtimo, Inc. | 2015-05-27 |
| SYNVISC (P940015/S035) | Sanofi Genzyme Corp. | 2015-05-26 |
| LCS TOTAL KNEE SYSTEM (P830055/S156) | Depuy, Inc. | 2015-05-26 |
| DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S031) | Dexcom, Inc. | 2015-05-22 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S047) | Allergan | 2015-05-22 |
| JUVEDERM VOLUMA XC (P110033/S014) | Allergan | 2015-05-22 |
| MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM (P140002) | Terumo Medical Corporation | 2015-05-22 |
| CARDIOMEMS HF SYSTEM (P100045/S005) | ABBOTT MEDICAL | 2015-05-22 |
| BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P080011/S037) | CooperVision, Inc. | 2015-05-21 |
| HERCEP TEST (P980018/S019) | Agilent Technologies Singapore (International) Pte , Ltd. | 2015-05-21 |
| OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, OVATION IX ILIAC STENT GRAFT (P120006/S019) | Endologix, LLC | 2015-05-21 |
| SUPERION INTERSPINOUS SPACER (P140004) | Boston Scientific Neuromodulation | 2015-05-20 |
| THERAPY DUAL 8 ABLATION CATHETER, THERAPY 8 MM THERMISTOR , SAFIRE TX ABLATION CATHETERS & GENERATORS (P040042/S030) | Irvine Biomedical,Inc.(Ibi) | 2015-05-20 |
| THERAPY ABLATION CATHETER INCLUDING BI-DIRECTIONAL CATHETER AND THERAPY 4MM THERNISTOR ABLATION CATHETER (P040014/S025) | Irvine Biomedical, Inc. | 2015-05-20 |
| LEICA BOND ORACLE HER2 IHC SYSTEM (P090015/S003) | Leica Biosystems | 2015-05-20 |
| THERAPY COOL PATH DUO ABLATION CATHETER AND THERAPY COOL FLEX ABLATION CATHETER (P110016/S017) | ABBOTT MEDICAL | 2015-05-20 |