| CYPASS SYSTEM (P150037/S002) | Alcon Research, Ltd. | 2017-03-15 |
| PROVISC Ophthalmic Viscosurgical Devices (P890047/S050) | Alcon Research, Ltd. | 2017-03-15 |
| Lenstec Softec HD Posterior Chamber Intraocular Lens (P090022/S032) | Lenstec, Inc. | 2017-03-15 |
| QUARTET 1457Q LV LEAD (P030054/S314) | ABBOTT MEDICAL | 2017-03-15 |
| IsoFlex Optim leads (LV Passive) (P960030/S051) | ABBOTT MEDICAL | 2017-03-14 |
| QuickFlex µ and Quartet leads (CRT) (P030054/S322) | ABBOTT MEDICAL | 2017-03-14 |
| VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA) (P160016) | Fujirebio Europe N.V. | 2017-03-14 |
| Tendril SDX/ST/STS and Optisense leads (LV Active) (P960013/S089) | ABBOTT MEDICAL | 2017-03-14 |
| HeartWare Ventricular Assist System (P100047/S091) | Medtronic | 2017-03-14 |
| Durata and Optisure leads (HV Active and Passive) (P950022/S101) | ABBOTT MEDICAL | 2017-03-14 |
| VENTANA ALK (D5F3) (P140025/S004) | Ventana Medical Systems, Inc. | 2017-03-13 |
| INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S026) | Ventana Medical Systems, Inc. | 2017-03-13 |
| Amplia MRI, Amplia MRI Quad, Brava, Brava Quad, Claria MRI, Claria Quad, Compia MRI, Compia MRI Quad, Viva Quad S, Viva (P010031/S585) | Medtronic Cardiac Rhythm Disease Management | 2017-03-13 |
| Micra TPS (P150033/S017) | Medtronic, Inc. | 2017-03-13 |
| PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S035) | Ventana Medical Systems, Inc. | 2017-03-13 |
| Evera MRI DF-1, Evera MRI, Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Visia AF MRI DF1, Visia AF MRI VR, Visia AF (P980016/S625) | Medtronic Cardiac Rhythm Disease Management | 2017-03-13 |
| PATHWAY ANTI-C-KIT (P020055/S019) | Ventana Medical Systems, Inc. | 2017-03-13 |
| SPECTRA WAVEWRITER SPINAL CORD STIMULATOR SYSTEM (P030017/S271) | Boston Scientific Corp | 2017-03-13 |
| Oxford Partial Knee System (P010014/S061) | Biomet Manufacturing Corp | 2017-03-11 |
| Adapta, Versa, Sensia IPG (P980035/S490) | Medtronic, Inc. | 2017-03-10 |
| Revo MRI SureScan IPG (P090013/S250) | Medtronic, Inc. | 2017-03-10 |
| LIFE VEST WEARABLE DEFIBRILLATOR (P010030/S087) | Zoll Manufacturing Corporation | 2017-03-10 |
| GELSYN-3 (P110005/S002) | Ibsa Institut Biochimique SA | 2017-03-10 |
| Wearable Cardioverter Defibrillator (WCD) 2000 Life Vest (P010030/S092) | Zoll Manufacturing Corporation | 2017-03-10 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Evera MRI ICD, Maximo II ICD (P010031/S582) | Medtronic Cardiac Rhythm Disease Management | 2017-03-10 |
| Pearl Vision Monthly (confilcon A) Soft (Hydriohilic) Contact Lenses , Pearle Vision Monthly for Astigmatism (comfilcon (P080011/S049) | CooperVision, Inc. | 2017-03-10 |
| Evera MRI DF-1, Protecta XT ICD (P980016/S623) | Medtronic Cardiac Rhythm Disease Management | 2017-03-10 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S321) | Medtronic, Inc. | 2017-03-10 |
| COFLEX INTERLAMINAR TECHNOLOGY (P110008/S007) | Companion Spine France | 2017-03-10 |
| Hancock II Bioprosthesis, Ultra Bioprosthesis (P980043/S057) | Medtronic, Inc. | 2017-03-09 |
| Mosaic Bioprosthesis, Mosaic Ultra Bioprosthesis (P990064/S066) | Medtronic, Inc. | 2017-03-09 |
| Parvovirus B19 IgM Enzyme Immunoassay (P970055/S015) | Diasorin | 2017-03-09 |
| Obalon Balloon Sustem (P160001/S005) | Medtimo, Inc. | 2017-03-09 |
| Medtronic CoreValve System/Medtronic Evolut R System (P130021/S030) | Medtronic, Inc. | 2017-03-09 |
| SynCardia Temporary Total Artificial Heart (P030011/S047) | Syncardia Systems, LLC | 2017-03-09 |
| SAPIEN XT Transcatheter Heart Valve (Frame only) Ascendra+Delivery System/NovaFlex+Delivery System/Edwards Expandable In (P130009/S070) | Edwards Lifesciences, LLC | 2017-03-09 |
| Freestyle Bioprosthesis (P970031/S055) | Medtronic, Inc. | 2017-03-09 |
| Parvovirus B19 IgG Enzyme Immunoassay (P970054/S013) | Diasorin | 2017-03-09 |
| Nucleus 24 Cochlear Implant System (P970051/S156) | Cochlear Americas | 2017-03-09 |
| SAPIEN 3 Transcatheter Heart Valve (Frame only) Commander Delivery System/Certitude Delivery System/ Certitude Introduce (P140031/S032) | Edwards Lifesciences, LLC | 2017-03-09 |
| Hancock Valved Conduit (P870078/S035) | Medtronic, Inc. | 2017-03-09 |
| Hancock Valved Conduit (P790007/S050) | Medtronic Heart Valves | 2017-03-09 |
| STAAR SURGICAL IMPLANTABLE COLLAMER LENS (VISION ICL) (P030016/S022) | STAAR Surgical Company | 2017-03-08 |
| Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S050) | Dexcom, Inc. | 2017-03-08 |
| MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM (P140002/S002) | Terumo Medical Corporation | 2017-03-08 |
| Evera MRI DF-1 ICD/ Evera MRI ICD/Evera S DR ICD/ Evera S VR ICD/ Evera XT DR ICD/Evera XT VR ICD/ Visia AF MRI DF1 ICD/ (P980016/S622) | Medtronic Cardiac Rhythm Disease Management | 2017-03-08 |
| Medtronic (R) Synchromed (TM) Pump & Infusion System (P860004/S269) | Medtronic, Inc. | 2017-03-08 |
| Surgifoam Absorbable Gelatin Sponge, USP (P990004/S030) | Ferrosan Meidcal Devices A/S | 2017-03-08 |
| Amplia MRI CRT-D/Amplia MRI Quad CRT-D/ Brava CRT-D/Claria Quad CRT-D/ Brava Quad CRT-D/ Compia MRI Quad CRT-D/ Viva Qua (P010031/S581) | Medtronic Cardiac Rhythm Disease Management | 2017-03-08 |
| Lutonix Drug Coated Balloon PTA Cateter (P130024/S018) | Lutonix | 2017-03-07 |
| FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled (P110016/S038) | ABBOTT MEDICAL | 2017-03-07 |
| QuantiFERON-TB GOLD Test (P010033/S032) | Qiagen | 2017-03-07 |
| GORE EXCLUDER AAA ENDOPROSTHESIS, GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (P020004/S137) | W. L. Gore & Associates, Inc. | 2017-03-06 |
| Subcutaneous Implantable Defibrillator (S-ICD) System. (P110042/S078) | Boston Scientific Corporation | 2017-03-06 |
| Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software (P140033/S005) | ABBOTT MEDICAL | 2017-03-06 |
| T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S016) | Tandem Diabetes Care, Inc. | 2017-03-06 |
| Carbomedics Prosthetic Heart Valve (CPHV). (P900060/S056) | Corcym S.r.l. | 2017-03-03 |
| Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM (P110025/S017) | Roche Diagnostics Corp. | 2017-03-03 |
| Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S064) | Medtronic Sofamor Danek USA, Inc. | 2017-03-03 |
| MOBI-C CERVICAL DISC PROSTHESIS (P110009/S016) | Highridge Medical, LLC | 2017-03-03 |
| ACRYSOF Posterior Chamber INTRAOCULAR LENSES (P930014/S094) | Alcon Laboratories, Inc. | 2017-03-03 |
| Multi-Piece Posterior Chamber IOL (P810032/S065) | Alcon Laboratories | 2017-03-03 |
| Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM (P110022/S019) | Roche Diagnostics Corp. | 2017-03-03 |
| Single-Piece Posterior Chamber IOL (P840060/S042) | Alcon Laboratories | 2017-03-03 |
| ACRYSOF RESTOR POSTERIOR CHAMBER IOL (P040020/S064) | Alcon Research, Ltd. | 2017-03-03 |
| SENOGRAPHE PRISTINA 3D (P130020/S002) | GE Healthcare | 2017-03-03 |
| XIENCE V NANO, XIENCE PRIME XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM; HI-TORQUE PROGRESS, PILOT GUIDE (P110019/S085) | Abbott Vascular | 2017-03-03 |
| Single-Piece Anterior Chamber IOL (P880087/S024) | Alcon Laboratories | 2017-03-03 |
| Infuse Bone Graft (P050053/S037) | Medtronic, Inc. | 2017-03-03 |
| TECNIS TORIC 1-PIECE INTRAOCULAR LENSES (IOLS) EXTENDED CYLINDER RANGE (ECR), MODELS ZCT450, ZCT525 AND ZCT600 (P980040/S077) | Johnson & Johnson Surgical Vision, Inc. | 2017-03-03 |
| Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM (P110031/S016) | Roche Diagnostics Corp. | 2017-03-03 |
| Infuse Bone Graft (P000054/S046) | Medtronic Sofamor Danek USA, Inc. | 2017-03-03 |
| MOBI-C CERVICAL DISC PROSTHESIS. (P110002/S016) | Highridge Medical, LLC | 2017-03-03 |
| XIENCE V NANO, XIENCE PRIME XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM; HI-TORQUE PROGRESS, PILOT GUIDE (P070015/S133) | Abbott Vascular, Inc. | 2017-03-03 |
| Elecsys free PSA, free PSA Calset, free PSA CalCheck (P000027/S023) | Roche Diagnostics Corp. | 2017-03-02 |
| ACRYSOF ASPHERIC UV ABSORBING TORIC INTRAOCULAR LENSES (P930014/S099) | Alcon Laboratories, Inc. | 2017-03-02 |
| INTELLATIP MIFI OPEN-IRRIGATED ABLATION CATHETER (P150005/S008) | Boston Scientific Corp | 2017-03-02 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S064) | ABBOTT MEDICAL | 2017-03-02 |
| VITAGEL RT3 SUTGICAL HEMOSTAT (P050044/S033) | Stryker Corp. | 2017-03-02 |
| Elecsys total PSA, total PSA CalSet II (P990056/S024) | Roche Diagnostics Corp. | 2017-03-02 |
| MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S016) | Medtronic, Inc. | 2017-03-02 |
| ACRYSOF ASPHERIC UV-ABSORBING RESTOR +2.5 INRAOCULAR LENS & ACRTSOF ASPHERIC UV-ABSORBING RESTOR +3.0 INTRAOCULAR LENS (P040020/S066) | Alcon Research, Ltd. | 2017-03-02 |
| HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE (P850010/S074) | Integra LifeSciences Corporation | 2017-03-01 |
| COLLACOTE(TM) COLLATAPE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY (P840062/S061) | Integra Lifesciences Corp. | 2017-03-01 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE (P810006/S075) | Integra LifeSciences Corporation | 2017-03-01 |
| CARTIVA SYNTHETIC CARTILAGE IMPLANT (P150017/S005) | Cartiva, Inc. | 2017-03-01 |
| EDWARDS COMMANDER DELIVERY SYSTEM (P140031/S030) | Edwards Lifesciences, LLC | 2017-03-01 |
| NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022/S012) | Nevro Corporation | 2017-03-01 |
| VISTAKON Brand Contact Lenses (N18033/S088) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2017-03-01 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S060) | Integra Lifesciences Corp. | 2017-03-01 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S076) | Boston Scientific Corporation | 2017-03-01 |
| Advisa DR IPG A4DR01, Advisa DR MRI IPG A2DR01, Advisa SR MRI IPG A3SR01 (P980035/S488) | Medtronic, Inc. | 2017-02-28 |
| VISUMAX FEMTOSECOND LASER SYSTEM (P150040/S001) | Carl Zeiss Meditec, Inc. | 2017-02-28 |
| COBAS E 601 (P110022/S020) | Roche Diagnostics Corp. | 2017-02-28 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S026) | OraSure Technologies, Inc. | 2017-02-28 |
| COBAS E 411 (P110031/S017) | Roche Diagnostics Corp. | 2017-02-28 |
| METHAFILCON A AND METHAFILCON B SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P850079/S073) | CooperVision, Inc. | 2017-02-28 |
| Amplia MRI/Amplia MRI Quad/Brava/Brava Quad/Claria MRI/Claria MRI Quad/Compia MRI/Concerto II/Consulta/Maximo II/Viva Qu (P010031/S580) | Medtronic Cardiac Rhythm Disease Management | 2017-02-28 |
| POLYMACON SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P780007/S056) | CooperVision, Inc. | 2017-02-28 |
| EDWARDS INTUITY ELITE VALVE SYSTEM (P150036/S005) | Edwards Lifesciences, LLC | 2017-02-28 |