| SUPARTZ FX (P980044/S025) | Seikagaku Corp. | 2015-05-20 |
| THERAPY COOL PATH ABLATION CATHETERS (INCLUDING ALL BRAID MODELS) (P060019/S031) | Irvine Biomedical, Inc. | 2015-05-20 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S112) | Advanced Bionics | 2015-05-19 |
| MINIMED 530G SYSTEM (P120010/S062) | Medtronic, Inc. | 2015-05-19 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S115) | Advanced Bionics | 2015-05-19 |
| CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S178) | Medtronic Minimed | 2015-05-19 |
| VALITUDE CRT-P (P030005/S121) | Guidant Corp. | 2015-05-19 |
| ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 PACEMAKERS (N970003/S173) | Boston Scientific Corp | 2015-05-19 |
| VALITUDE CRT-P (P030005/S120) | Guidant Corp. | 2015-05-19 |
| ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 PACEMAKERS (N970003/S174) | Boston Scientific Corp | 2015-05-19 |
| INGENIO 2 CRT-P DEVICES (P030005/S119) | Guidant Corp. | 2015-05-19 |
| SYNCHROMED INFUSION SYSTEM (P860004/S227) | Medtronic, Inc. | 2015-05-18 |
| ENROUTE TRANSCAROTID STENT SYSTEM (P140026) | Boston Scientific Corporation | 2015-05-18 |
| INTERSTIM THERAPY SYSTEM (P970004/S198) | Medtronic Neuromodulation | 2015-05-18 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S226) | Medtronic, Inc. | 2015-05-18 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S225) | Medtronic, Inc. | 2015-05-18 |
| RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULAT (P840001/S300) | Medtronic Neuromodulation | 2015-05-18 |
| INTERSTIM THERAPY SYSTEM (P080025/S093) | Medtronic Neuromodulation | 2015-05-18 |
| MARGINPROBE SYSTEM (P110014/S005) | Dilon Medical Technologies, Ltd. | 2015-05-18 |
| LIFE PULSE HIGH FREQUENCY VENTILATOR (P850064/S023) | Bunnell, Inc. | 2015-05-15 |
| ENLITE SENSOR (P120010/S066) | Medtronic, Inc. | 2015-05-15 |
| MEDTRONIC OPEN PIVOT AORTIC VALVED GRAFT (P990046/S040) | Medtronic Ats Medical, Inc. | 2015-05-15 |
| CAROTID WALLSTENT ENDOPROSTHESIS (P050019/S021) | Boston Scientific Corp | 2015-05-15 |
| SENSAR 1-PIECE INTRAOCULAR LENS (IOL) (P980040/S059) | Johnson & Johnson Surgical Vision, Inc. | 2015-05-15 |
| ADAPTA,VERSA,SENSIA IPG, RELIA IPG (P980035/S422) | Medtronic, Inc. | 2015-05-14 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S044) | Boston Scientific Corp | 2015-05-14 |
| CARDIOMESSENGER, RELIATY, RENAMIC, REOCOR (P950037/S152) | Biotronik, Inc. | 2015-05-14 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS) (P130005/S004) | Cardiovascular Systems, Inc. | 2015-05-14 |
| CAPSURE SENSE LEAD (P830061/S120) | Medtronic Cardiac Rhythm Disease Management | 2015-05-14 |
| NIRXCELL COCR-CORONARY STENT ON RX SYSTEM (P110004/S010) | Medinol, Ltd. | 2015-05-14 |
| ASSURITY, ASSURITY+ AND ENDURITY FAMILY OF PACEMAKER DEVICES (P880086/S256) | ABBOTT MEDICAL | 2015-05-14 |
| CAPSUREFIX MRI LEAD (P090013/S185) | Medtronic, Inc. | 2015-05-14 |
| CAPSUREFIX NOVUS LEAD (P930039/S128) | Medtronic, Inc. | 2015-05-14 |
| ALLURE AND ALLURE QUADRA FAMILY OF CRT-P DEVICES (P030035/S134) | ABBOTT MEDICAL | 2015-05-14 |
| CARDIOMESSENGER (P050023/S088) | Biotronik, Inc. | 2015-05-14 |
| FINELINE II PACE/SENSE LEAD (P960004/S068) | Boston Scientific | 2015-05-14 |
| SOF-SENSOR (P980022/S166) | Medtronic Minimed | 2015-05-13 |
| ENLITE SENSOR (P120010/S040) | Medtronic, Inc. | 2015-05-13 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S008) | Abbott Vascular (Idef Technologies Inc) | 2015-05-12 |
| ROTABLATOR RATATIONAL ANGIOPLASTY SYSTEM (P900056/S144) | Boston Scientific Corp | 2015-05-12 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S054) | St Jude Medical | 2015-05-11 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S220) | Medtronic, Inc. | 2015-05-11 |
| PRECISION SPECTRA TM SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S223) | Boston Scientific Corp | 2015-05-11 |
| BLAZER II, BLAZER II HTD, BLAZER PRIME HTD (P920047/S079) | Boston Scientific Corp | 2015-05-11 |
| DURASEAL EXACT SPINE SEALANT (P080013/S011) | Integra LifeSciences Corporation | 2015-05-11 |
| BLAZER PRIME XP, BLAZER PRIME XP, INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S070) | Boston Scientific | 2015-05-11 |
| CRYOCONSOLE (P020045/S064) | Medtronic Cryocath, LP | 2015-05-11 |
| COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S021) | Roche Molecular Systems, Inc. | 2015-05-08 |
| MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S028) | Mentor Corp. | 2015-05-08 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S046) | Roche Molecular Systems, Inc. | 2015-05-08 |
| NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022) | Nevro Corporation | 2015-05-08 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.0 (P060030/S047) | Roche Molecular Systems, Inc. | 2015-05-08 |
| MENTOR MEMORYSHAPE BREAST IMPLANTS (P060028/S011) | Mentor Worldwide, LLC | 2015-05-08 |
| APTIMA HCV RNA QUALITATIVE ASSAY (P020011/S008) | Gen-Probe | 2015-05-08 |
| MITRACLIP CLIP DELIVERY SYSTEM, MITRACLIP STEERABLE GUIDE CATHETER (P100009/S011) | ABBOTT MEDICAL | 2015-05-07 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S073) | W. L. Gore & Associates, Inc. | 2015-05-07 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S224) | Boston Scientific Corp | 2015-05-07 |
| PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT (P100044/S017) | Intersect Ent. | 2015-05-07 |
| GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S077) | W. L. Gore & Associates, Inc. | 2015-05-07 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S016) | W. L. Gore & Associates, Inc. | 2015-05-07 |
| COBAS KRAS MUTATION TEST (P140023) | Roche Molecular Systems, Inc. | 2015-05-07 |
| EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S024) | Ferring Pharmaceuticals, Inc. | 2015-05-07 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S113) | W. L. Gore & Associates, Inc. | 2015-05-07 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS) (P000053/S059) | Boston Scientific Corp | 2015-05-06 |
| RADIESSE AND RADIESSE(+) (P050052/S064) | Merz North America, Inc. | 2015-05-06 |
| RADIESSE (P050037/S058) | Merz North America, Inc. | 2015-05-06 |
| STAR S4 IR EXCIMER LASER SYSTEM WITH IDESIGN WAVESCAN STUDIO SYSTEM (P930016/S044) | Amo Manufacturing USA, LLC | 2015-05-06 |
| ENDURANT II STENT GRAFT SYSTEM, ENDURANT IIS STENT GRAFT SYSTEM (P100021/S047) | Medtronic Vascular | 2015-05-06 |
| AMS ACTICON NEOSPHINCTER- ARTIFICIAL BOWL SPHINCTER (ABS) (P010020/S032) | Boston Scientific Corp | 2015-05-06 |
| OXFORD PARTIAL KNEE SYSTEM (P010014/S051) | Biomet Manufacturing Corp | 2015-05-06 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S108) | Boston Scientific Corp | 2015-05-06 |
| MONOVISC INJECTABLE INTRA-ARTICULAR DEVICES (P090031/S004) | Anika Therapeutics, Inc. | 2015-05-05 |
| WAVELIGHT EX500 LASER SYSTEM (P020050/S022) | Alcon Laboratories, Inc. | 2015-05-05 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S051) | Vistakon, Division of Johnson & Johnson Vision Car | 2015-05-05 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S077) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2015-05-05 |
| WAVELIGHT EX500 LASER SYSTEM (P030008/S020) | Alcon Laboratories, Inc. | 2015-05-05 |
| ACRYSOF IQ POSTERIOR CHAMBER IOL (P930014/S079) | Alcon Laboratories, Inc. | 2015-05-05 |
| ORTHOVISC INJECTABLE INTRA-ARTICULAR DEVICES (P030019/S022) | Anika Therapeutics, Inc. | 2015-05-05 |
| LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S038) | Alcon Laboratories, Inc. | 2015-05-05 |
| MAXUM (P010023/S011) | Ototronix, LLC | 2015-05-04 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC MAXIMO ICD, MAXIMO II CRT-D, PROTECTA CRT-D, (P010031/S501) | Medtronic Cardiac Rhythm Disease Management | 2015-05-04 |
| ANCHORING SLEEVE KIT, SELECTSECURE LEAD (P030036/S078) | Medtronic Cardiac Rhythm Disease Management | 2015-05-04 |
| ADHESIVE, CAPSURE SENSE LEAD, CAPSURE SP LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ (P830061/S121) | Medtronic Cardiac Rhythm Disease Management | 2015-05-04 |
| MEDTRONIC MODEL 25000 MY CARELINK SMART READER (P890003/S328) | Medtronic, Inc. | 2015-05-04 |
| CAPSUREFIX MRI LEAD, REVO MRI SURESCAN IPG (P090013/S186) | Medtronic, Inc. | 2015-05-04 |
| CAPSURE VDD 2 LEAD,PRODIGY IPG,SERVICE KIT-PACEMAKER REPAIR KIT,VITATRON BRILLIANT S+ VDD LEAD (P890003/S331) | Medtronic, Inc. | 2015-05-04 |
| VIRTUOSO,SECURA, MAXIMO II ,VIRTUOSO II , PROTECTA XT ,PROTECTA VT,EVERA (XT/S) ,EVERA S AND XT VR AND DR'S (P980016/S535) | Medtronic Cardiac Rhythm Disease Management | 2015-05-04 |
| ADAPTA, VERSA,SENSIA IPG,ADVISA (DR/DR MRI) IPGS,ENRHYTHM MRI,ENPULSE (E1/E2) IPG,KAPPA D(700/900) IPG,KAPPA DR(650) IPG (P980035/S415) | Medtronic, Inc. | 2015-05-04 |
| END CAP,EPICARDIAL PATCH LEAD ,UPSIZING SLEEVE (P900061/S135) | Medtronic Cardiac Rhythm Disease Management | 2015-05-04 |
| REVO MRI (P090013/S179) | Medtronic, Inc. | 2015-05-04 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S064) | Medtronic, Inc. | 2015-05-04 |
| TRANSVENE CS/SVC LEAD (P980050/S100) | Medtronic, Inc. | 2015-05-04 |
| RF CONTACTR,RF ENHANCR II,RF CONDUCTR,RF MARINR 5F,RF MARINR 7FR (P930029/S051) | Medtronic, Inc. | 2015-05-04 |
| EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD, (P980016/S538) | Medtronic Cardiac Rhythm Disease Management | 2015-05-04 |
| ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,ADVISA SR MRI IPG (P980035/S423) | Medtronic, Inc. | 2015-05-04 |
| ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LEAD (P010015/S272) | Medtronic, Inc. | 2015-05-04 |
| ATTAIN ABILITY LEAD, ATTAIN PERFORMA LEAD, ATTAIN PERFORMA LEAD (P080006/S079) | Medtronic, Inc. | 2015-05-04 |
| ATTAIN STARFIX LEAD (P060039/S067) | Medtronic, Inc. | 2015-05-04 |
| CAPSUREFIX LEAD,CAPSUREFIX NOVUS LEAD,SUREFIX LEAD,VITATRON CRYSTALLINE ACTIVE FIXATION LEADS (P930039/S129) | Medtronic, Inc. | 2015-05-04 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S268) | Medtronic, Inc. | 2015-05-04 |