| SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S037) | Edwards Lifesciences, LLC | 2016-02-29 |
| LIVEWIRE(R) CARDIAC ABLATION SYSTEM (P960016/S061) | St Jude Medical | 2016-02-29 |
| Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRTD DTBC1Q1, DTBC1QQ; Concerto II CRTD, D274TRK; Consulta CRT-D D204TRM, D224T (P010031/S529) | Medtronic Cardiac Rhythm Disease Management | 2016-02-29 |
| Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever (P980016/S568) | Medtronic Cardiac Rhythm Disease Management | 2016-02-29 |
| IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF (P060019/S036) | Irvine Biomedical, Inc. | 2016-02-29 |
| Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever (P980016/S570) | Medtronic Cardiac Rhythm Disease Management | 2016-02-29 |
| TACTICATH QUARTZ SET (P130026/S016) | St Jude Medical | 2016-02-29 |
| Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever (P980016/S566) | Medtronic Cardiac Rhythm Disease Management | 2016-02-29 |
| Revo MRI SureScan IPG RVDR01 (P090013/S217) | Medtronic, Inc. | 2016-02-29 |
| Advisa DR IPG A4DR01; Advisa DR MRI IPG A2DR01; Advisa SR MRI IPG A3SR01 (P980035/S455) | Medtronic, Inc. | 2016-02-29 |
| SOFT-FORM 55EW; LL-55; SOFTCON EW2 (P890040/S008) | Unilens Corp., USA | 2016-02-29 |
| THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER (P040042/S034) | Irvine Biomedical,Inc.(Ibi) | 2016-02-29 |
| IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR (P040014/S029) | Irvine Biomedical, Inc. | 2016-02-29 |
| GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (P020004/S123) | W. L. Gore & Associates, Inc. | 2016-02-29 |
| Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ; Viva Quad S CRT-D DTBB1Q1, DTBB1QQ, Viva Quad XT CRT-D (P010031/S527) | Medtronic Cardiac Rhythm Disease Management | 2016-02-29 |
| Consulta CRT-P C4TR01; Syncra CRT-P C2TR01 (P010015/S292) | Medtronic, Inc. | 2016-02-29 |
| THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR (P110016/S029) | ABBOTT MEDICAL | 2016-02-29 |
| ACRYSOF MULTIFOCAL INTRAOCULAR LENS (P040020/S060) | Alcon Research, Ltd. | 2016-02-29 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S243) | Medtronic, Inc. | 2016-02-29 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S119) | Boston Scientific Corp | 2016-02-26 |
| GENESIS,EON,EON C , EON MINI,PROTEGE, BRIO FAMILIES OF DEVICES (P140009/S011) | ABBOTT MEDICAL | 2016-02-26 |
| VNS THERAPY ASPIRESR GENERATOR; VNS THERAPY PROGRAMMING SOFTWARE (P970003/S189) | LivaNova USA, Inc. | 2016-02-26 |
| GENESIS,EON,EON C , EON MINI,PROTEGE, BRIO FAMILIES OF DEVICES (P010032/S112) | ABBOTT MEDICAL | 2016-02-26 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P130030/S020) | Boston Scientific Corp | 2016-02-26 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S071) | Boston Scientific Corp | 2016-02-26 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S125) | W. L. Gore & Associates, Inc. | 2016-02-26 |
| ORBERA INTRAGASTRIC BALLOON SYSTEM (P140008/S002) | Boston Scientific Corporation | 2016-02-26 |
| TRANSCEND HIP ARTICULATION SYSTEM (P010001/S016) | Ceramtec GmbH | 2016-02-25 |
| TRANSCEND HIP ARTICULATION SYSTEM (P010001/S015) | Ceramtec GmbH | 2016-02-25 |
| D-STAT FLOWABLE HEMOSTAT (P990037/S032) | Vascular Solutions, Inc. | 2016-02-25 |
| COMPLETE SE VASCULAR STENT SYSTEM (P110040/S007) | Medtronic Vascular | 2016-02-25 |
| MONOVISC (P090031/S006) | Anika Therapeutics, Inc. | 2016-02-25 |
| ORTHOVISC (P030019/S023) | Anika Therapeutics, Inc. | 2016-02-25 |
| THERAKOS CELLEX PROCEDURAL KIT (P860003/S084) | Therakos Development Limited | 2016-02-25 |
| LIVEWIRE TC ABLATION CATHETER, SAFIRE ABLATION CATHETER (P960016/S059) | St Jude Medical | 2016-02-24 |
| ELECSYS ANTI-HBC TEST SYSTEM (P100031/S015) | Roche Diagnostics Corp. | 2016-02-24 |
| ELECSYS HBSAG TEST SYSTEM (P990012/S025) | Roche Diagnostics Corp. | 2016-02-24 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S053) | ABBOTT MEDICAL | 2016-02-24 |
| ELECSYS ANTI-HBC TEST SYSTEM (P100032/S012) | Roche Diagnostics Corp. | 2016-02-24 |
| BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005) | Boston Scientific Corp | 2016-02-24 |
| PROMUS ELEMENT PLUS/ PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S102) | Boston Scientific Corp | 2016-02-24 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S025) | ABBOTT MEDICAL | 2016-02-24 |
| INTELLANAV XP TEMPERATURE ABLATION CATHETER, INTELLANAV MIFI XP TEMPERATURE ABLATION CATHETER, INTELLANAV ABLATION CATHE (P020025/S077) | Boston Scientific | 2016-02-24 |
| AMPLATZER DUCT OCCLUDER, AMPLATZER DUCT OCCLUDER II, (P020024/S042) | ABBOTT MEDICAL | 2016-02-24 |
| FLEXABILITY ABLATION CATHETER (P110016/S024) | ABBOTT MEDICAL | 2016-02-24 |
| ELECSYS ANTI-HCV II TEST SYSTEM (P140021/S004) | Roche Diagnostics Operations, Inc. | 2016-02-24 |
| TACTICATH QUARTZ ABLATION CATHETER (P130026/S011) | St Jude Medical | 2016-02-24 |
| PERCEVAL SUTURELESS HEART VALVE (P150011/S001) | Corcym S.r.l. | 2016-02-24 |
| ELECSYS ANTI-HBC IGM TEST SYSTEM (P110022/S016) | Roche Diagnostics Corp. | 2016-02-24 |
| CP900 SERIES SOUND PROCESSORS (P970051/S132) | Cochlear Americas | 2016-02-24 |
| ELECSYS ANTI-HBC IGM TEST SYSTEM (P110025/S014) | Roche Diagnostics Corp. | 2016-02-24 |
| ELECSYS ANTI-HCV TEST SYSTEM (P090009/S014) | Roche Diagnostics Corp. | 2016-02-24 |
| ELECSYS ANTI-HBS TEST SYSTEM (P010054/S027) | Roche Diagnostics Corp. | 2016-02-24 |
| ELECSYS ANTI-HCV TEST SYSTEM (P090008/S016) | Roche Diagnostics Corp. | 2016-02-24 |
| THERAPY COOL PATH ABLATION CATHETER AND IBI-1500T9 RF ABLATION GENERATOR (P060019/S032) | Irvine Biomedical, Inc. | 2016-02-24 |
| ELECSYS ANTI-HBC IGM TEST SYSTEM (P110031/S013) | Roche Diagnostics Corp. | 2016-02-24 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S051) | ABBOTT MEDICAL | 2016-02-24 |
| LCS TOTAL KNEE SYSTEM (P830055/S167) | Depuy, Inc. | 2016-02-24 |
| TRANSCEND HIP ARTICULATION SYSTEM (P010001/S017) | Ceramtec GmbH | 2016-02-24 |
| ELECSYS ANTI-HCV TEST SYSTEM (P090007/S014) | Roche Diagnostics Corp. | 2016-02-24 |
| MINERVA ENDOMETRIAL ABLATION SYSTEM (P140013/S001) | Axora Medical, Inc. | 2016-02-23 |
| LOTRAFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S044) | Alcon Laboratories, Inc. | 2016-02-23 |
| DEFLUX INJECTABLE GEL (P000029/S080) | Palette Life Sciences | 2016-02-23 |
| ACUITY X4 STRAIGHT (4671,4672), SPIRAL S (4674,4675), SPIRAL L (4677,4678) LEADS; SUTURELESS SLEEVE & FLUSHING TOOL/WIRE (P010012/S398) | Boston Scientific Corp | 2016-02-22 |
| THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (LVAS), THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (P060040/S048) | ABBOTT MEDICAL | 2016-02-22 |
| RADIESSE INJECTABLE IMPLANT (P050037/S067) | Merz North America, Inc. | 2016-02-22 |
| EDWARDS COMMANDER DELIVERY SYSTEM (P140031/S007) | Edwards Lifesciences, LLC | 2016-02-22 |
| RELIANCE 4-SITE LEAD FAMILY (P910073/S132) | Boston Scientific | 2016-02-22 |
| MiniMed 530G System (P120010/S061) | Medtronic, Inc. | 2016-02-22 |
| RADIESSE,RADIESSE (+) LIDOCAINE DERMAL FILLER (P050052/S078) | Merz North America, Inc. | 2016-02-22 |
| EVERA MRI, EVERA, MARQUIS, SECURA, MAXIMO II, INTRINSIC, PROTECTA, PROTECTA XT, VIRTUOSO II (P980016/S563) | Medtronic Cardiac Rhythm Disease Management | 2016-02-22 |
| Ellipse DR Models CD2311-36, CD2311-36Q, CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC; Ellipse VR Models CD1311-36, CD (P910023/S369) | ABBOTT MEDICAL | 2016-02-22 |
| ADAPTA, VERSA, SENSIA, ADVISA, ADVISA MRI,ENPULSE, KAPPA (P980035/S450) | Medtronic, Inc. | 2016-02-22 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S288) | Medtronic, Inc. | 2016-02-22 |
| Victory Models 5816, 5810, 5610; Zephyr Models 5820, 5826, 5620, 5626; Accent Models PM1110, PM1210, PM2110, PM2210; As (P880086/S269) | ABBOTT MEDICAL | 2016-02-22 |
| MYCARE LINK PATIENT MONITOR (P890003/S346) | Medtronic, Inc. | 2016-02-22 |
| REVO MRI (P090013/S211) | Medtronic, Inc. | 2016-02-22 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S038) | Syncardia Systems, LLC | 2016-02-22 |
| VIVA, BRAVA, PROTECTA, PROTECTA XT, CONCERTO, CONCERTO II, CONSULTA, MAXIMO II, INSYNC II PROTECT (P010031/S524) | Medtronic Cardiac Rhythm Disease Management | 2016-02-22 |
| Assurity Models PM1240, PM2240; Assurity+ Models PM1260, PM2260; Endurity Models PM1160, PM2160; Endurity Core Models CD (P880086/S270) | ABBOTT MEDICAL | 2016-02-22 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S022) | OraSure Technologies, Inc. | 2016-02-20 |
| PULSE/PULSE DUO GENERATOR-MODEL 102/102R (P970003/S188) | LivaNova USA, Inc. | 2016-02-19 |
| TACTICATH QUARTZ SET (P130026/S015) | St Jude Medical | 2016-02-19 |
| SYNCHROMED II PUMP (P860004/S245) | Medtronic, Inc. | 2016-02-18 |
| THERAPY ABLATION CATHETERS (P040014/S028) | Irvine Biomedical, Inc. | 2016-02-18 |
| THERAPY DUAL 8, THERAPY 8MM THERMISTOR, AND SAFIRE TX ABLATION CATHETERS, AND 1500T6 AND 1500T9 RF GENERATOR (P040042/S033) | Irvine Biomedical,Inc.(Ibi) | 2016-02-18 |
| BRACANALYSIS CDX DEVICE (P140020/S005) | Myriad Genetic Laboratories | 2016-02-18 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.0 (P060030/S048) | Roche Molecular Systems, Inc. | 2016-02-18 |
| OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS (P910066/S028) | Djo, LLC | 2016-02-18 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S089) | W. L. Gore & Associates, Inc. | 2016-02-18 |
| THERAPY COOL PATH DUO,SAFIRE BLU DUO AND COOL PATH DUO,THERAPY COOL PATH DUO SP,SAFIRE BLU DUO SP,THERAY COOL FLEX CATHP (P110016/S027) | ABBOTT MEDICAL | 2016-02-18 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S028) | W. L. Gore & Associates, Inc. | 2016-02-18 |
| THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS) (P060040/S050) | ABBOTT MEDICAL | 2016-02-18 |
| MINIMED 530G SYSTEM (P120010/S070) | Medtronic, Inc. | 2016-02-18 |
| LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER AND SAFIRE BI-DIRECTIONAL ABLATION CATHETER (P960016/S060) | St Jude Medical | 2016-02-18 |
| TACTICATH QUARTZ SET (P130026/S012) | St Jude Medical | 2016-02-18 |
| THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP AND THERAPY COOL PATH SP ABLATION CATHETERS, AND 1500T9-CP RF GENERATORS (P060019/S035) | Irvine Biomedical, Inc. | 2016-02-18 |
| CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (P990023/S013) | Alcon Laboratories | 2016-02-18 |
| DURATA AND OPTISURE HV LEADS (P950022/S091) | ABBOTT MEDICAL | 2016-02-17 |
| TENDRIL SDX, ST, STS, AND OPTISCIENSE L V LEADS (P960013/S079) | ABBOTT MEDICAL | 2016-02-17 |