| PARADIGM REAL-TIME REVEL SYSTEM (P150019/S003) | Medtronic Minimed | 2016-03-16 |
| ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER (P090009/S015) | Roche Diagnostics Corp. | 2016-03-16 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S534) | Medtronic Cardiac Rhythm Disease Management | 2016-03-16 |
| NUCLEUS CI532 COCHLEAR IMPLANT SYSTEM (P970051/S133) | Cochlear Americas | 2016-03-16 |
| ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER (P090008/S017) | Roche Diagnostics Corp. | 2016-03-16 |
| MEDTRONIC(R) TRANSVENE LEAD SYSTEM (P920015/S174) | Medtronic, Inc. | 2016-03-16 |
| ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC (P100031/S016) | Roche Diagnostics Corp. | 2016-03-16 |
| AUGMENT BONE GRAFT (P100006/S002) | Biomimetic Therapeutics, LLC | 2016-03-16 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM (P110022/S017) | Roche Diagnostics Corp. | 2016-03-16 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S573) | Medtronic Cardiac Rhythm Disease Management | 2016-03-16 |
| EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S002) | Edwards Lifesciences, LLC | 2016-03-16 |
| ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV (P140021/S006) | Roche Diagnostics Operations, Inc. | 2016-03-16 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S011) | Cardiovascular Systems, Inc. | 2016-03-16 |
| ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER (P100032/S013) | Roche Diagnostics Corp. | 2016-03-16 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM (P110031/S014) | Roche Diagnostics Corp. | 2016-03-16 |
| PARADIGM REAL-TIME REVEL SYSTEM (P150019/S004) | Medtronic Minimed | 2016-03-16 |
| NEUROPACE RNS SYSTEM (P100026/S040) | NeuroPace, Inc. | 2016-03-15 |
| SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S012) | Scott Laboratories, Inc. | 2016-03-15 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S535) | Medtronic Cardiac Rhythm Disease Management | 2016-03-15 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S574) | Medtronic Cardiac Rhythm Disease Management | 2016-03-15 |
| FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P000030/S001) | Alcon Laboratories, Inc. | 2016-03-14 |
| FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P010019/S046) | Alcon Laboratories, Inc. | 2016-03-14 |
| MARGINPROBE SYSTEM (P110014/S006) | Dilon Medical Technologies, Ltd. | 2016-03-14 |
| ROTABLATOR(R) (P900056/S152) | Boston Scientific Corp | 2016-03-11 |
| Consulta, Syncra, Viva CRT-P (P010015/S294) | Medtronic, Inc. | 2016-03-11 |
| ADVIA CENTAUR AHBCM ASSAY (P030040/S009) | Siemens Healthcare Diagnostics | 2016-03-11 |
| AKREOS INTRAOCULAR LENS (P060022/S022) | Bausch & Lomb, Inc. | 2016-03-11 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S457) | Medtronic, Inc. | 2016-03-11 |
| ARCTIC FRONT CRYOCATHETER SYSTEM (P100010/S053) | Medtronic Cryocath, LP | 2016-03-11 |
| PRESTIGE(R) LP CERVICAL DISC (P090029/S002) | Medtronic Sofamor Danek USA, Inc. | 2016-03-11 |
| LIFESTENT VASCULAR STENT SYSTEMS (P070014/S048) | Bard Peripheral Vascular, Inc. | 2016-03-11 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM (P020045/S074) | Medtronic Cryocath, LP | 2016-03-11 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM (P090013/S218) | Medtronic, Inc. | 2016-03-11 |
| BRAVA;BRAVA QUAD; CONCERTO II;CONSULTA;MAXIMO II;PROTECTA;PROTECTA XT;VIVA QUAD S;VIVA QUAD XT;VIVA S;VIVA XT CRT-DS (P010031/S526) | Medtronic Cardiac Rhythm Disease Management | 2016-03-10 |
| THE PERCEVAL SUTURELESS HEART VALVE (P150011/S002) | Corcym S.r.l. | 2016-03-10 |
| LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2). (P910018/S018) | Kaneka Pharma America Corp. | 2016-03-10 |
| MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM (P960009/S247) | Medtronic, Inc. | 2016-03-10 |
| ATS OPEN PIVOT BILEAFLET HEART VALVE (P990046/S046) | Medtronic Ats Medical, Inc. | 2016-03-10 |
| ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS (P840001/S322) | Medtronic Neuromodulation | 2016-03-10 |
| ASTRON STENT SYSTEM (P140030/S001) | Biotronik AG | 2016-03-10 |
| THE SOLO SMART STENTLESS HEART VALVE (P130011/S003) | Corcym Canada Corp | 2016-03-10 |
| EVERA MRI; EVERA S DR;EVERA XT DR; EVERA XT VR; MAXIMO II; PROTECTA; PROTECTA XT; SECURA ICDS (P980016/S565) | Medtronic Cardiac Rhythm Disease Management | 2016-03-10 |
| LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S010) | Lutonix | 2016-03-10 |
| MYNX ACE VASCULAR CLOSURE DEVICE (MYNX ACE ) (P040044/S070) | Cordis US Corporation | 2016-03-10 |
| PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR (P820033/S010) | Asahi Kasei Medical Co., Ltd. | 2016-03-09 |
| HYDRASOFT (METHAFILCON B) CONTACT LENS (P850079/S070) | CooperVision, Inc. | 2016-03-09 |
| RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S061) | Medtronic Vascular | 2016-03-09 |
| ATS OPEN PIVOT BILEAFLET HEART VALVE (P990046/S045) | Medtronic Ats Medical, Inc. | 2016-03-09 |
| FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P010019/S045) | Alcon Laboratories, Inc. | 2016-03-09 |
| Dynagen Models G150, G151, G154, G156, G158; Inogen Models G140, G141, G146, G148; Origen Models G050, G051, G056, G0 (P010012/S410) | Boston Scientific Corp | 2016-03-09 |
| Dynagen Models D150, D151, D152, D153; Inogen Models D140, D141, D142, D143; Origen Models D050, D051, D052, D053 ICD (P960040/S364) | Boston Scientific | 2016-03-09 |
| ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS (P840001/S323) | Medtronic Neuromodulation | 2016-03-08 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S532) | Medtronic Cardiac Rhythm Disease Management | 2016-03-08 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S571) | Medtronic Cardiac Rhythm Disease Management | 2016-03-08 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S007) | Boston Scientific Corporation | 2016-03-07 |
| ABBOTT REALTIME HCV GENOTYPE II (P120012/S010) | Abbott Molecular | 2016-03-07 |
| EXTERNAL PULSE GENERATOR, 16 CHANNEL, EXTERNAL PULSE GENERATOR, 2 PORT HEADER (P010032/S108) | ABBOTT MEDICAL | 2016-03-07 |
| BIO OSTEOGEN SYSTEM 204 (P790002/S035) | Ahp Eos Buyer, Inc. | 2016-03-07 |
| MEDTRONIC COREVALVE SYSTEM (P130021/S019) | Medtronic, Inc. | 2016-03-06 |
| INTEGRITY RAPID EXCHANGE CORONARY STENT SYSTEMS (P030009/S083) | Medtronic, Ireland | 2016-03-04 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S090) | Boston Scientific Corp | 2016-03-04 |
| CHILLI COOLED RF ABLATION SYSTEM (P980003/S065) | Boston Scientific Corp | 2016-03-04 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S089) | Boston Scientific Corp | 2016-03-04 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S005) | Boston Scientific Corporation | 2016-03-04 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S056) | Abbott Vascular | 2016-03-04 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S246) | Boston Scientific Corp | 2016-03-04 |
| TRIDENT CERAMIC INSERT (P000013/S013) | Howmedica Osteonics Corp. | 2016-03-04 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S060) | Medtronic Vascular | 2016-03-04 |
| NEUROPACE RNS SYSTEM (P100026/S042) | NeuroPace, Inc. | 2016-03-04 |
| ACUVUE CONTACT LENS (N18033/S080) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2016-03-04 |
| EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM (P020025/S084) | Boston Scientific | 2016-03-04 |
| EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM (P020025/S083) | Boston Scientific | 2016-03-04 |
| VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (P040045/S055) | Vistakon, Division of Johnson & Johnson Vision Car | 2016-03-04 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NG3 EXTENDED LIFE ICD: DYNAGEN, INOGEN, ORIGEN, NG2 5 MINI ICD DYNAGEN, INOGEN, (P960040/S363) | Boston Scientific | 2016-03-03 |
| PARVOVIRUS B19 IgG ENZYME IMMUNOASSAY (V519GUS) (P970054/S011) | Diasorin | 2016-03-03 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S034) | Medtimo, Inc. | 2016-03-03 |
| BRIO IMPLANTABLE PULSE GENERATORS (IPGS) (P140009/S012) | ABBOTT MEDICAL | 2016-03-03 |
| PARADIGM REAL-TIME REVEL SYSTEM (P150019/S001) | Medtronic Minimed | 2016-03-03 |
| SELECTSECURE LEAD (P030036/S082) | Medtronic Cardiac Rhythm Disease Management | 2016-03-03 |
| CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR, NG3 CRT-D DYNAGEN CRT-D & X4 CRT-D, INOGEN CRT-D & X4 CRT-D. ORIGEN CRT (P010012/S409) | Boston Scientific Corp | 2016-03-03 |
| PARADIGM REAL-TIME REVEL SYSTEM (P150019/S002) | Medtronic Minimed | 2016-03-03 |
| ENDURANT II & ENDURANT IIS STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-ILIAC STENT GRAFT SYSTEM (P100021/S051) | Medtronic Vascular | 2016-03-03 |
| EON, EONC, EON MINI, PROTEGE, PROTEGE MRI IMPLANTABLE PULSE GENERATORS (IPGS) (P010032/S113) | ABBOTT MEDICAL | 2016-03-03 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S082) | W. L. Gore & Associates, Inc. | 2016-03-02 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S015) | Torax Medical | 2016-03-02 |
| ORBERA INTRAGASTRIC BALLOON SYSTEM (P140008/S001) | Boston Scientific Corporation | 2016-03-02 |
| ANIMAS VIBE SYSTEM (P130007/S010) | Animas Corp. | 2016-03-02 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S016) | Torax Medical | 2016-03-02 |
| DISPOSABLE FALOPE-RING BAND APPLICATOR KITS (P870076/S021) | Gyrus Acmi, Inc. | 2016-03-02 |
| MELAFIND (P090012/S010) | Strata Skin Sciences, Inc. | 2016-03-02 |
| ADVISA DR IPG; ADVISA DR MRI IPG (P980035/S452) | Medtronic, Inc. | 2016-03-01 |
| EVERA MRI ICD, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO 11 ICD, VIVA AF VR ICD, VISIA AF (P980016/S567) | Medtronic Cardiac Rhythm Disease Management | 2016-03-01 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S291) | Medtronic, Inc. | 2016-03-01 |
| REVO MRI SURESCAN IPG (P090013/S215) | Medtronic, Inc. | 2016-03-01 |
| Reply SR, Reply DR, Esprit SR, Esprit DR (P950029/S109) | MicroPort CRM USA, Inc. | 2016-03-01 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROCETA XT CRT-D, VIVA QUAD S CRT-D, VIVA QUARD XT CRT-D (P010031/S528) | Medtronic Cardiac Rhythm Disease Management | 2016-03-01 |
| RENO MRI SURESCAN IPG (P090013/S216) | Medtronic, Inc. | 2016-03-01 |
| ADAPTA VERSA SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG, RELIA IPG (P980035/S454) | Medtronic, Inc. | 2016-03-01 |
| Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ; Concerto II CRT-D D274TRK; Consulta CRT-D D204TRM, D224 (P010031/S531) | Medtronic Cardiac Rhythm Disease Management | 2016-02-29 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S079) | Terumo Medical Corporation | 2016-02-29 |