| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S056) | ABBOTT MEDICAL | 2016-05-24 |
| BELOTERO BALANCE DERMAL FILLER (P090016/S013) | Merz North America, Inc. | 2016-05-24 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S582) | Medtronic Cardiac Rhythm Disease Management | 2016-05-24 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S087) | Med-El Corp. | 2016-05-24 |
| Consulta CRT-P C4TR01; Syncra CRT-P C2TR01; Viva CRT-P C6TR01 (P010015/S300) | Medtronic, Inc. | 2016-05-24 |
| MODEL 204 LIFE PULSE HIGH FREQUENCY VENTILATOR (P850064/S031) | Bunnell, Inc. | 2016-05-24 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S542) | Medtronic Cardiac Rhythm Disease Management | 2016-05-24 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S057) | ABBOTT MEDICAL | 2016-05-24 |
| ORBERA INTRAGASTRIC BALLOON SYSTEM (P140008/S003) | Boston Scientific Corporation | 2016-05-23 |
| Gel-Syn (P110005/S001) | Ibsa Institut Biochimique SA | 2016-05-23 |
| Adapta, Versa, Sensia IPG ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, A (P980035/S463) | Medtronic, Inc. | 2016-05-23 |
| LAP-BAND ADJUSTABLE GASTIC BANDING SYSTEM (P000008/S035) | Medtimo, Inc. | 2016-05-23 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S058) | Edwards Lifesciences, LLC | 2016-05-23 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S016) | Edwards Lifesciences, LLC | 2016-05-23 |
| INSPIRE PROGRAMMER SYSTEM (P130008/S012) | Inspire Medical Systems | 2016-05-20 |
| APTIMA HPV ASSAY (P100042/S010) | Gen-Probe Incorporated | 2016-05-20 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MR & OTW (P150003/S012) | Boston Scientific Corporation | 2016-05-20 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S125) | Boston Scientific Corp | 2016-05-20 |
| COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST (P110037/S023) | Roche Molecular Systems, Inc. | 2016-05-20 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S074) | Medtronic | 2016-05-19 |
| LIVEWIRE(R) TC CARDIAC ABLATION SYSTEM (P960016/S065) | St Jude Medical | 2016-05-19 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S017) | Torax Medical | 2016-05-19 |
| CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (P990023/S014) | Alcon Laboratories | 2016-05-18 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MR & OTW (P150003/S010) | Boston Scientific Corporation | 2016-05-18 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S047) | Alcon Research, Ltd. | 2016-05-18 |
| VISCOAT OPHTHALMIC VISCOSURGICAL DEVICES; DUOVISC OPTHALMIC VISCOSURGICAL DEVICES; DISCOVISC OPTHALMIC VISCOSURGICAL DEV (P840064/S061) | Alcon Laboratories | 2016-05-18 |
| VENTANA PD-L1(SP142) CDX ASSAY (P160002) | Ventana Medical Systems, Inc. | 2016-05-18 |
| NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ORIGEN EL ICD: D050, D051, D052, D053 INOGEN EL ICD: D140, D141, D142, (P960040/S371) | Boston Scientific | 2016-05-17 |
| CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S035) | DePuy Orthopaedics, Inc. | 2016-05-17 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S085) | W. L. Gore & Associates, Inc. | 2016-05-17 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S054) | Medtronic Cryocath, LP | 2016-05-17 |
| NG3 CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) DYNAGEN CRT-D: G150, G151, G154, X4 CRT-D; G156, G158 INOGEN (P010012/S418) | Boston Scientific Corp | 2016-05-17 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S006) | Globus Medical, Inc. | 2016-05-17 |
| Ethicon Endo-Surgery Curved Adjustable Gastric Band with Sutureless Port and Applier; Ethicon Endo-Surgery Gastric Band (P070009/S016) | Obtech Medical GmbH | 2016-05-16 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S036) | Bard Peripheral Vascular | 2016-05-16 |
| INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S011) | Inspire Medical Systems | 2016-05-16 |
| SURGIFLO HEMOSTATIC MATRIX KIT WITH THROMBIN (P990004/S025) | Ferrosan Meidcal Devices A/S | 2016-05-16 |
| FLUENCY PLUS ENDOVASCULAR STENT GRAFT (P130029/S001) | Bard Peripheral Vascular, Inc. | 2016-05-16 |
| SUPARTZ FX (P980044/S032) | Seikagaku Corp. | 2016-05-13 |
| COBAS KRAS MUTATION TEST (P140023/S005) | Roche Molecular Systems, Inc. | 2016-05-13 |
| COBAS HPV TEST (P100020/S019) | Roche Molecular Systems, Inc. | 2016-05-13 |
| TECNIS 1-PIECE IOL, MULTIFOCAL 1-PIECE IOL, TORIC 1-PIECE IOL WITH THE TECNIS iTEC PRELOADED DELIVERY SYSTEM (P980040/S068) | Johnson & Johnson Surgical Vision, Inc. | 2016-05-13 |
| ALGOVITA SPINAL CORD STIMULATION SYSTEM (P130028/S006) | Nuvectra Corporation | 2016-05-13 |
| IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT (P120011/S005) | Bimini Health Tech | 2016-05-13 |
| COBAS TAQMAN HBV TEST (P050028/S051) | Roche Molecular Systems, Inc. | 2016-05-13 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S051) | Roche Molecular Systems, Inc. | 2016-05-13 |
| COBAS 4800 BRAF V600 MUTATION TEST (P110020/S015) | Roche Molecular Systems, Inc. | 2016-05-13 |
| COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0 (P000012/S055) | Roche Molecular Systems, Inc. | 2016-05-13 |
| COBAS EGFR MUTATION TEST (P120019/S009) | Roche | 2016-05-13 |
| SYNCHROMED INFUSION SYSTEM (P860004/S249) | Medtronic, Inc. | 2016-05-13 |
| COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) (P110037/S026) | Roche Molecular Systems, Inc. | 2016-05-13 |
| GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S017) | Glaukos Corporation | 2016-05-13 |
| CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+, FAMILY OF ICDS (P910023/S362) | ABBOTT MEDICAL | 2016-05-12 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S001) | Siemens Medical Solutions USA, Inc. | 2016-05-12 |
| ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY PACEMAKERS (P880086/S261) | ABBOTT MEDICAL | 2016-05-12 |
| PROMOTE/+/RF/Q,PROMOTE ACCEL,PROMOTE QUADRA,UNIFY,UNIFY ASSURA,UNIFY QUADRA,QUADRA ASSURA,EPIC+/HF/HF+/IIHF/II+HF,ATLAS+ (P030054/S292) | ABBOTT MEDICAL | 2016-05-12 |
| KAMRA INLAY (P120023/S001) | Corneagen | 2016-05-12 |
| ESSURE SYSTEM (P020014/S044) | Bayer Pharma AG | 2016-05-12 |
| ANIMAS VIBE SYSTEM (P130007/S013) | Animas Corp. | 2016-05-12 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S082) | Terumo Medical Corporation | 2016-05-12 |
| ANTHEM, ALLURE/RF, QUADRA ALLURE/RF FAMILY OF CRT-PS (P030035/S139) | ABBOTT MEDICAL | 2016-05-12 |
| PARADYM VR 8750,PARADYM DR 8750,PARADYM RF VR 9750,PARADYM RF DR 9750(ZL101),PARADYM RF VR 9750, PARADYM RF DR 9750(ZL10 (P980049/S114) | MicroPort CRM USA, Inc. | 2016-05-11 |
| IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT (P120011/S004) | Bimini Health Tech | 2016-05-11 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S012) | Boston Scientific Corporation | 2016-05-11 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S108) | MicroPort CRM USA, Inc. | 2016-05-11 |
| PARADYM CRT-D 8750,PARADYM RF CRT-D 9750(ZL101),PARADYM RF CRT-D 9750(ZL102),INTENSIA CRT-D (P060027/S080) | MicroPort CRM USA, Inc. | 2016-05-11 |
| RF MARINR CATHETERS, RF ENHANCER II CATHETERS, RF CONTRACTR CATHETERS AND RF CONDUCTR CATHETERS (P930029/S052) | Medtronic, Inc. | 2016-05-11 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S010) | Boston Scientific Corporation | 2016-05-11 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S086) | Med-El Corp. | 2016-05-11 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S024) | Boston Scientific Corp | 2016-05-10 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S124) | Boston Scientific Corp | 2016-05-10 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S009) | Boston Scientific Corporation | 2016-05-10 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S023) | OraSure Technologies, Inc. | 2016-05-10 |
| MITRACLIP NT CLIP DELIVERY SYSTEM (P100009/S015) | ABBOTT MEDICAL | 2016-05-10 |
| CORDIS S.M.A.R.T.AND S.M.A.R.T.CONTROL VASCULAR STENT SYSTEM (P120002/S007) | Cordis US Corporation | 2016-05-09 |
| INTEGRA(R) DERMAL REGENERATION TEMPLATE, INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE (P900033/S053) | Integra Lifesciences Corp. | 2016-05-09 |
| EVERA MRI ICD, EVERA S DR ICD, EVERA S VR ICD, EVERA XT CR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA X (P980016/S584) | Medtronic Cardiac Rhythm Disease Management | 2016-05-09 |
| AMPLIA MRI CRT-D, AMPLIA MRI QUAD CRT-D, BRAVA CRT-D, BRAVA QUAD CRT-D, COMPIA MRI CRT-D, COMPIA MRI QUAD CRT-D, CONCERT (P010031/S545) | Medtronic Cardiac Rhythm Disease Management | 2016-05-09 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG,RELIA IPG. (P980035/S462) | Medtronic, Inc. | 2016-05-09 |
| Origen, Dynagen, Inogen EL ICD; Origen, Dynagen, Inogen MINI ICD (P960040/S369) | Boston Scientific | 2016-05-09 |
| Dynagen, Inogen, Origen CRT-D; Dynagen, Inogen, Origen X4 CRT-D (P010012/S415) | Boston Scientific Corp | 2016-05-09 |
| CONSULTA, SYNCRA, VIVA CRT-P (P010015/S299) | Medtronic, Inc. | 2016-05-09 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S146) | Edwards Lifesciences, LLC | 2016-05-06 |
| ANGIO SEAL VASCULAR CLOSURE DEVICE (P930038/S081) | Terumo Medical Corporation | 2016-05-06 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S055) | Edwards Lifesciences, LLC | 2016-05-06 |
| VISTAKON (SENOFILCON A) CONTACT LENS (P040045/S056) | Vistakon, Division of Johnson & Johnson Vision Car | 2016-05-06 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S081) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2016-05-06 |
| ALERE NMP22(TM) TEST (P940035/S012) | Abbott Diagnostics Scarborough, Inc. | 2016-05-06 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S013) | Edwards Lifesciences, LLC | 2016-05-06 |
| COLOGUARD (P130017/S009) | Exact Sciences Corporation | 2016-05-05 |
| OVATION ABDOMINAL STENT GRAFT SYSTEM (P120006/S023) | Endologix, LLC | 2016-05-05 |
| WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (P130013/S007) | Boston Scientific Corp | 2016-05-05 |
| IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S017) | Medtronic, Inc. | 2016-05-05 |
| ACTIVA DEEP BRIAN STIMULATION THERAPY SYSTEM (P960009/S249) | Medtronic, Inc. | 2016-05-05 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S212) | Medtronic Neuromodulation | 2016-05-05 |
| THERAKOS UVAR XTS Photopheresis System Procedural Kit (P860003/S086) | Therakos Development Limited | 2016-05-05 |
| EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S130) | W. L. Gore & Associates, Inc. | 2016-05-05 |
| LUTONIX DRUG COATED BALLOON PTA CATHETER (P130024/S012) | Lutonix | 2016-05-05 |
| RESTORE, ITREL. AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEAD (P840001/S326) | Medtronic Neuromodulation | 2016-05-05 |
| INTERSTIM THERAPY SYSTEM (P080025/S107) | Medtronic Neuromodulation | 2016-05-05 |