| SYNCHROMED INFUSION SYSTEM (P860004/S248) | Medtronic, Inc. | 2016-05-05 |
| CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S031) | DePuy Orthopaedics, Inc. | 2016-05-04 |
| THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM (P000039/S055) | ABBOTT MEDICAL | 2016-05-04 |
| AMPLATZER MULTI-FENESTRATED SEPTAL OCCULDER (CRIBRIFORM) (P020024/S045) | ABBOTT MEDICAL | 2016-05-04 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S028) | ABBOTT MEDICAL | 2016-05-04 |
| MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) (P140017/S003) | Medtronic, Inc. | 2016-05-04 |
| MATRIX VASCULAR CLOSURE SYSTEM (VSG) (P040044/S072) | Cordis US Corporation | 2016-05-04 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S022) | Cryolife, Inc. | 2016-05-04 |
| ADAPTA, VERSA, SENSIA IPG. ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG, ENOUKSE E2 IOG, KAPPA D IPG,KAPPA DR IP (P980035/S447) | Medtronic, Inc. | 2016-05-03 |
| EVERA MRI ICD, S DR ICD, S VR ICD, XT DR ICD, ST VR ICF, INTRINSIC 30 ICD, MARQUIS VR ICD, MAXIMO II ICD, PROTECT ICD, S (P980016/S562) | Medtronic Cardiac Rhythm Disease Management | 2016-05-03 |
| MAXUM SYSTEM (P010023/S012) | Ototronix, LLC | 2016-05-03 |
| RENO MRI SURESCAN IPG (P090013/S209) | Medtronic, Inc. | 2016-05-03 |
| VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S365) | Boston Scientific | 2016-05-03 |
| LCS TOTAL KNEE SYSTEM (P830055/S168) | Depuy, Inc. | 2016-05-03 |
| PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (N970003/S186) | Boston Scientific Corp | 2016-05-03 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S287) | Medtronic, Inc. | 2016-05-03 |
| CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE (P030005/S133) | Guidant Corp. | 2016-05-03 |
| WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE (P130013/S008) | Boston Scientific Corp | 2016-05-03 |
| MEDTRONIC MODEL 31301 CARELINK EXPRESS APP. (P890003/S345) | Medtronic, Inc. | 2016-05-03 |
| INTEGRA DERMAL REGENERATION TEMPLATE - TERMINALLY STERILIZED (P900033/S054) | Integra Lifesciences Corp. | 2016-05-03 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S411) | Boston Scientific Corp | 2016-05-03 |
| COLOGUARD (P130017/S008) | Exact Sciences Corporation | 2016-05-03 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D; MAXIMO II CRT-D, PROTECTA CRT-D, PROTECT (P010031/S523) | Medtronic Cardiac Rhythm Disease Management | 2016-05-03 |
| IPERIA 7 HF-T (DR-1) & (DF-4); INVENTRA 7 HF-T (DF-1) & (DF-4) (P050023/S094) | Biotronik, Inc. | 2016-05-02 |
| Drug-Eluting Permanent Defibrillator Electrodes, Accessories to Implantable Pacemaker Pulse Generator (P980023/S074) | Biotronik, Inc. | 2016-05-02 |
| SETROX S 53, SAFIO S 53 (P950037/S161) | Biotronik, Inc. | 2016-05-02 |
| PROGRAMMER SOFTWARE (1507.U) FOR THE ICS 3000/RENAMIC PROGRAMMERS (P000009/S065) | Biotronik, Inc. | 2016-05-02 |
| CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045/S008) | ABBOTT MEDICAL | 2016-05-02 |
| RADIESSE (+) 0.8CC, RADIESSE (+) 1.5CC (P050052/S073) | Merz North America, Inc. | 2016-05-02 |
| COROX OTW 75 BP & 85 BP; COROX OTW-L 75 BP & 85 BP; COROX OTW-S 75 BP & 85 BP (P070008/S070) | Biotronik, Inc. | 2016-05-02 |
| Durata and Optisure HV leads (P950022/S092) | ABBOTT MEDICAL | 2016-05-01 |
| IsoFlex Optim LV leads (P960030/S044) | ABBOTT MEDICAL | 2016-05-01 |
| QuickFlex u and Quartet CRT leads (P030054/S303) | ABBOTT MEDICAL | 2016-05-01 |
| Tendril SDX, ST, STS and OptiSense LV leads (P960013/S081) | ABBOTT MEDICAL | 2016-05-01 |
| ACCESS THERAPY PATIENT CONTROLLER,ACCESS REVIEW THERAPY CONTROLLER (P960009/S173) | Medtronic, Inc. | 2016-04-29 |
| COBAS TAQMAN HBV TEST (P050028/S050) | Roche Molecular Systems, Inc. | 2016-04-29 |
| GENESIS EON,EONC,EON MINI,PROTEGE,PROTEGE MRI,AND PROCLAIM FAMILY SPINAL CORD STIMULATION (SCS) SYSTEMS (P010032/S100) | ABBOTT MEDICAL | 2016-04-29 |
| LIVEWIRE CARDIAC ABLATION SYSTEM (P960016/S056) | St Jude Medical | 2016-04-29 |
| ITREL EZ PATIENT PROGRAMMER,SYNERGY EZ PATIENT PROGRAMMER,ACCESS THERAPY PATIENT CONTROLLER (P840001/S242) | Medtronic Neuromodulation | 2016-04-29 |
| ACUITY SPIRAL LEAD MODELS (P010012/S407) | Boston Scientific Corp | 2016-04-29 |
| CARDIOMEMS (P100045/S006) | ABBOTT MEDICAL | 2016-04-29 |
| THERAPY COOL PATH ABLATION CATHETER, THERAPY COOL PATH SP ABLATION CATHETE, SAFIRE BLU ABLATION CATHETER, SAFIRE BLU SP (P060019/S033) | Irvine Biomedical, Inc. | 2016-04-29 |
| AMPLATZER SEPTAL OCCLUDER,CRIBRIFORM OCLUDER,AND DELIVERY AND EXCHANGE SYSTEMS (P000039/S052) | ABBOTT MEDICAL | 2016-04-29 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S050) | Roche Molecular Systems, Inc. | 2016-04-29 |
| JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS (P050047/S052) | Allergan | 2016-04-29 |
| COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) (P110037/S025) | Roche Molecular Systems, Inc. | 2016-04-29 |
| COBAS HPV TEST (P100020/S018) | Roche Molecular Systems, Inc. | 2016-04-29 |
| BRIO FAMILY DEEP BRAIN STIMULATION (DBS) SYSTEMS (P140009/S004) | ABBOTT MEDICAL | 2016-04-29 |
| ANGIO-SEAL STS+,ANGIO-SEAL VIP, AND ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICES (P930038/S077) | Terumo Medical Corporation | 2016-04-29 |
| VNS THERAPY SYSTEM (P970003/S190) | LivaNova USA, Inc. | 2016-04-29 |
| GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S116) | ABBOTT MEDICAL | 2016-04-29 |
| THERAPY DUAL 8 CATHETER,THERAPY 8MM THERMISTOR ABLATION CATHETER, SAFIRE TX, AND ASSOCIATED CABLES (P040042/S031) | Irvine Biomedical,Inc.(Ibi) | 2016-04-29 |
| THERAPY COOL PATH DUO ABLATION, THERAPY COOL PATH SP ABLATION CATHETER,SAFIRE BLU DUO ABLATION CATHETER,SAFIRE BLU DUO S (P110016/S021) | ABBOTT MEDICAL | 2016-04-29 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM (P090013/S223) | Medtronic, Inc. | 2016-04-29 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S543) | Medtronic Cardiac Rhythm Disease Management | 2016-04-29 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S581) | Medtronic Cardiac Rhythm Disease Management | 2016-04-29 |
| COBAS HBV TEST (P150014/S002) | Roche Molecular Systems, Inc. | 2016-04-29 |
| MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015/S297) | Medtronic, Inc. | 2016-04-29 |
| THERAPY CARDIAC ABLATION CATHETER (P040014/S026) | Irvine Biomedical, Inc. | 2016-04-29 |
| COBAS HCV TEST (P150015/S002) | Roche Molecular Systems, Inc. | 2016-04-29 |
| ENDOTAK RELIANCE IS-1 AND ENDOTAK RELIANCE 4-SITE LEAD MODELS (P910073/S133) | Boston Scientific | 2016-04-29 |
| THE MED-EL C40 + COCHLEAR IMPLANT (P000025/S085) | Med-El Corp. | 2016-04-29 |
| MyCareLink Patient Monitor Model 24950 (P890003/S351) | Medtronic, Inc. | 2016-04-29 |
| AMPLATZER DUCT OCCLUDER AND DELIVERY AND EXCHANGE SYSTEMS (P020024/S041) | ABBOTT MEDICAL | 2016-04-29 |
| BRACANALYSIS CDX (P140020/S001) | Myriad Genetic Laboratories | 2016-04-29 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S460) | Medtronic, Inc. | 2016-04-29 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S044) | Zimmer, Inc. | 2016-04-29 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S024) | ABBOTT MEDICAL | 2016-04-29 |
| FINELINE II STEROX AND STEROX EZ LEADS (P960004/S075) | Boston Scientific | 2016-04-29 |
| PERCEVAL SUTURELESS HEART VALVE (P150011/S004) | Corcym S.r.l. | 2016-04-29 |
| PRECISION MONTAGE MRI SPINAL CORD STIMULATOR SYSTEM, PRECISION MONTAGE SPINAL CORD STIMULATOR SYSTEM (P030017/S235) | Boston Scientific Corp | 2016-04-28 |
| THE HANCOCK VALVE CONDUIT LOW POROSITY (MODEL 150) (P870078/S031) | Medtronic, Inc. | 2016-04-28 |
| Tendril ST 1888/1882 TC; Tendril STS 2088 TC; Optisense 1999 (P960013/S080) | ABBOTT MEDICAL | 2016-04-28 |
| THE HANCOCK VALVED CONDUIT MODIFIED ORIFICE (MODEL 105) (P790007/S047) | Medtronic Heart Valves | 2016-04-28 |
| BLAZER PRIME HTD,BLAZER II,BLAZER II HTD TEMPERATURE ABLATION CATHETERS (P920047/S088) | Boston Scientific Corp | 2016-04-28 |
| VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX (P880086/S263) | ABBOTT MEDICAL | 2016-04-28 |
| CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 (P930039/S142) | Medtronic, Inc. | 2016-04-28 |
| ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL (P040020/S063) | Alcon Research, Ltd. | 2016-04-28 |
| ISOFLEX OPTIM (P960030/S040) | ABBOTT MEDICAL | 2016-04-28 |
| CareLink Programmer (Model 2090), Encore Programmer (Model 29901) (P890003/S350) | Medtronic, Inc. | 2016-04-28 |
| ADVISA MRI DR/SR SURESCAN IPGS AND PROGRAMMER SOFTWARE (P980035/S442) | Medtronic, Inc. | 2016-04-28 |
| ANTHEM, ALLURE, ALLURE RF, ALLURE QUADRA, ALLURE QUADRA RF (P030035/S141) | ABBOTT MEDICAL | 2016-04-28 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S055) | ABBOTT MEDICAL | 2016-04-28 |
| DURATA, DURATA, OPTISURE (P950022/S089) | ABBOTT MEDICAL | 2016-04-28 |
| CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI (P090013/S205) | Medtronic, Inc. | 2016-04-28 |
| MICRONY (P970013/S067) | ABBOTT MEDICAL | 2016-04-28 |
| BLAZER PRIME XP,INTELLATIP MIFI XP, BLAZER II XP TEMPERATURE ABLATION CATHETERS (P020025/S082) | Boston Scientific | 2016-04-28 |
| ESSURE SYSTEM (P020014/S045) | Bayer Pharma AG | 2016-04-28 |
| CURRENT+, FORTIFY, FORTIFY ASSURA, ELLIPSE (P910023/S365) | ABBOTT MEDICAL | 2016-04-28 |
| TENDRIL SDX LEAD, TENDRIL ST LEAD, OPTISENSE, TENDRIL STS LEAD (P960013/S078) | ABBOTT MEDICAL | 2016-04-28 |
| EVERA MRI XT DR/VR SURESCAN,EVERA MRI S DR/VR SURESCAN ICDS AND PROGRAMMER SOFTWARE (P980016/S555) | Medtronic Cardiac Rhythm Disease Management | 2016-04-28 |
| IsoFlex 1944, 1948 (P960030/S043) | ABBOTT MEDICAL | 2016-04-28 |
| PROMOTE+, UNIFY, UNIFY QUADRA, UNIFY ASSURA, QUADRA ASSURA, QUICKFLEX U, QUARTET (P030054/S295) | ABBOTT MEDICAL | 2016-04-28 |
| ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES (P930014/S090) | Alcon Laboratories, Inc. | 2016-04-28 |
| SPRINT QUATTRO SECURE S MRI SURESCAN LEAD MODEL 6935M,SPRINT QUATTRO SECURE MRI SURESCAN LEAD MODEL 6947M (P920015/S166) | Medtronic, Inc. | 2016-04-28 |
| MINIMED 530G SYSTEM (P120010/S088) | Medtronic, Inc. | 2016-04-27 |
| QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE (P010033/S028) | Qiagen | 2016-04-27 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S027) | Corcym Canada Corp | 2016-04-27 |
| SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) (P030011/S043) | Syncardia Systems, LLC | 2016-04-27 |
| PARADIGM REAL-TIME REVEL SYSTEM (P150019/S013) | Medtronic Minimed | 2016-04-27 |