| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S052) | Edwards Lifesciences, LLC | 2016-04-13 |
| SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S085) | Spectranetics Corp. | 2016-04-13 |
| BELOS DR/DR-T/VR-VR-T LEXOS DR/DR-T/VR-VR-T; LUMOS DR-T/VR-T; XELOS DR-T (P000009/S064) | Biotronik, Inc. | 2016-04-13 |
| PATHWAY ANTI-HER-2/NEU (4B5)RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S034) | Ventana Medical Systems, Inc. | 2016-04-13 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S541) | Medtronic Cardiac Rhythm Disease Management | 2016-04-13 |
| STRATOS LV/LV-T, EVIA HF/HF-T; ENTOVIS HF/HF-T (P070008/S069) | Biotronik, Inc. | 2016-04-13 |
| ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV (P100017/S016) | Abbott Molecular, Inc. | 2016-04-12 |
| Epi proColon (P130001) | New Day Diagnostics, LLC | 2016-04-12 |
| RADIESSE (+) LIDOCAINE DERMAL FILLER (P050052/S080) | Merz North America, Inc. | 2016-04-12 |
| RADIESSE INJECTABLE IMPLANT (P050037/S069) | Merz North America, Inc. | 2016-04-12 |
| THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM (P000039/S054) | ABBOTT MEDICAL | 2016-04-12 |
| DAKOCYTOMATION HER2 FISH PHARMDX KIT (P040005/S013) | Agilent Technologies Singapore (International) Pte , Ltd. | 2016-04-12 |
| ABBOTT REALTIME HBV ASSAY (P080026/S017) | Abbott Molecular, Inc. | 2016-04-12 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S027) | ABBOTT MEDICAL | 2016-04-12 |
| HER2 CISH PHARMDX KIT (P100024/S009) | Dako Denmark A/S | 2016-04-12 |
| ELECSYS ANTI-HCV II IMMUNOASSAY (P140021/S002) | Roche Diagnostics Operations, Inc. | 2016-04-12 |
| TACTICATH QUARTZ SET (P130026/S019) | St Jude Medical | 2016-04-12 |
| AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM (P020024/S044) | ABBOTT MEDICAL | 2016-04-12 |
| CapSure SP Novus Lead 5092, 5592, 5594; CapSure Z Novus Lead 5054, 5554 (P850089/S117) | Medtronic Cardiac Rhythm Disease Management | 2016-04-12 |
| ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG) (P120012/S012) | Abbott Molecular | 2016-04-12 |
| LIVEWIRE(R) CARDIAC ABLATION SYSTEM (P960016/S063) | St Jude Medical | 2016-04-12 |
| THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR (P110016/S030) | ABBOTT MEDICAL | 2016-04-12 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S009) | Boston Scientific Corporation | 2016-04-12 |
| AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM (P020024/S043) | ABBOTT MEDICAL | 2016-04-12 |
| CapSure Sense Lead 4074, 4574; CapSure SP Novus Lead 4092, 4592 (P830061/S128) | Medtronic Cardiac Rhythm Disease Management | 2016-04-12 |
| TRIDYNE VASCULAR SEALANT (P150016) | Neomend, Inc. | 2016-04-11 |
| BELOTERO BALANCE (P090016/S020) | Merz North America, Inc. | 2016-04-11 |
| VYSIS CLL FISH PROBE KIT (P150041) | Abbott Molecular, Inc. | 2016-04-11 |
| EXCLUDER AAA ENDOPROSTHESIS (P020004/S128) | W. L. Gore & Associates, Inc. | 2016-04-08 |
| MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015/S296) | Medtronic, Inc. | 2016-04-08 |
| THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT (P860003/S083) | Therakos Development Limited | 2016-04-08 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S459) | Medtronic, Inc. | 2016-04-08 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM (P090013/S222) | Medtronic, Inc. | 2016-04-08 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S008) | Boston Scientific Corporation | 2016-04-08 |
| EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM (P020025/S085) | Boston Scientific | 2016-04-08 |
| SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S084) | Spectranetics Corp. | 2016-04-07 |
| SURGIFOAM ABSORBABLE GELATIN SPONGE,U.S.P. (P990004/S029) | Ferrosan Meidcal Devices A/S | 2016-04-07 |
| IMPELLA LEFT VENTRICULAR SUPPORT SYSTEM (P140003/S005) | Abiomed, Inc. | 2016-04-07 |
| SYNERGY EVEROLIMUS ELUTING PLATINUM CHROMIUN CORONARY STENT SYSTEM MONORAIL & OVER THE WIRE. (P150003/S002) | Boston Scientific Corporation | 2016-04-07 |
| GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S029) | W. L. Gore & Associates, Inc. | 2016-04-07 |
| IMPELLA VENTRICULAR SUPPORT SYSTEMS (P140003/S004) | Abiomed, Inc. | 2016-04-07 |
| PARADIGM REAL-TIME REVEL SYSTEM (P150019/S010) | Medtronic Minimed | 2016-04-07 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S020) | Cryolife, Inc. | 2016-04-07 |
| VIABAHN ENDOPROSTHESIS (P040037/S090) | W. L. Gore & Associates, Inc. | 2016-04-07 |
| EXCLUDER AAA ENDOPROSTHESIS (P020004/S127) | W. L. Gore & Associates, Inc. | 2016-04-07 |
| MINIMED 530G SYSTEM (P120010/S085) | Medtronic, Inc. | 2016-04-07 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S054) | Edwards Lifesciences, LLC | 2016-04-06 |
| ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS (P110029/S023) | Abbott Laboratories | 2016-04-06 |
| DURASPHERE INJECTABLE BULKING AGENT (P980053/S016) | Carbon Medical Technologies, Inc. | 2016-04-06 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S083) | W. L. Gore & Associates, Inc. | 2016-04-06 |
| MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033) | Medtronic, Inc. | 2016-04-06 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S038) | Medtronic Vascular | 2016-04-05 |
| WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (P130013/S006) | Boston Scientific Corp | 2016-04-05 |
| THXID-BRAF KIT (P120014/S006) | bioMerieux, Inc. | 2016-04-05 |
| PARADIGM REAL-TIME REVEL SYSTEM (P150019/S009) | Medtronic Minimed | 2016-04-05 |
| CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S190) | Medtronic Minimed | 2016-04-05 |
| MINIMED 530G SYSTEM (P120010/S084) | Medtronic, Inc. | 2016-04-05 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S054) | ABBOTT MEDICAL | 2016-04-05 |
| BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S003) | Boston Scientific Corp | 2016-04-05 |
| BIOFINITY (COMFILCON A) (P080011/S042) | CooperVision, Inc. | 2016-04-05 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S016) | ABBOTT MEDICAL | 2016-04-05 |
| EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S129) | W. L. Gore & Associates, Inc. | 2016-04-04 |
| Sprint Quattro Lead 6946M; Sprint Quattro Lead 6935, 6935M, 6944, 6947, 6947M (P920015/S176) | Medtronic, Inc. | 2016-04-04 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S019) | LeMaitre Vascular, Inc. | 2016-04-04 |
| SYNVISC ONE (P940015/S036) | Sanofi Genzyme Corp. | 2016-04-04 |
| ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES (P930014/S089) | Alcon Laboratories, Inc. | 2016-04-01 |
| ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL (P040020/S061) | Alcon Research, Ltd. | 2016-04-01 |
| PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S249) | Boston Scientific Corp | 2016-04-01 |
| HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM (P150026) | Cardiofocus, Inc. | 2016-04-01 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S082) | Abbott Vascular | 2016-03-31 |
| MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM (P960009/S248) | Medtronic, Inc. | 2016-03-31 |
| TACTICATH QUARTZ SET (P130026/S018) | St Jude Medical | 2016-03-31 |
| ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS (P840001/S325) | Medtronic Neuromodulation | 2016-03-31 |
| MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM (P860004/S247) | Medtronic, Inc. | 2016-03-31 |
| RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S062) | Medtronic Vascular | 2016-03-31 |
| LIVEWIRE(R) CARDIAC ABLATION SYSTEM (P960016/S062) | St Jude Medical | 2016-03-31 |
| MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM (P080025/S106) | Medtronic Neuromodulation | 2016-03-31 |
| PIPELINE EMBOLIZATION DEVICE (P100018/S014) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2016-03-31 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S211) | Medtronic Neuromodulation | 2016-03-31 |
| ONYX LIQUID EMBOLIC SYSTEM (P030004/S010) | Ev3 Neurovascular | 2016-03-31 |
| BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S002) | Boston Scientific Corp | 2016-03-30 |
| MITRACLIP DELIVERY SYSTEM (P100009/S017) | ABBOTT MEDICAL | 2016-03-30 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S011) | Boston Scientific Corporation | 2016-03-30 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR (P000044/S034) | Ortho-Clinical Diagnostics, Inc. | 2016-03-30 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S539) | Medtronic Cardiac Rhythm Disease Management | 2016-03-30 |
| ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS (P840001/S324) | Medtronic Neuromodulation | 2016-03-30 |
| DUNE MEDICAL DEVICES MARGINPROBE SYSTEM (P110014/S007) | Dilon Medical Technologies, Ltd. | 2016-03-30 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S578) | Medtronic Cardiac Rhythm Disease Management | 2016-03-30 |
| FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P010019/S049) | Alcon Laboratories, Inc. | 2016-03-30 |
| IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S014) | Medtronic, Inc. | 2016-03-29 |
| GEL-ONE (P080020/S008) | Seikagaku Corp. | 2016-03-29 |
| COLLACOTE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY (P840062/S052) | Integra Lifesciences Corp. | 2016-03-29 |
| COLLASTA ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM (P810006/S068) | Integra LifeSciences Corporation | 2016-03-29 |
| HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S067) | Integra LifeSciences Corporation | 2016-03-29 |
| TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD (P050023/S096) | Biotronik, Inc. | 2016-03-29 |
| INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE (P900033/S051) | Integra Lifesciences Corp. | 2016-03-29 |
| STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD (P070008/S071) | Biotronik, Inc. | 2016-03-29 |
| DYNAGEN CRT-D Models G150, G151, G154, G156, G158; INOGEN CRT-D (P010012/S406) | Boston Scientific Corp | 2016-03-28 |
| SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (P090022/S026) | Lenstec, Inc. | 2016-03-28 |
| APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S008) | Gen-Probe Incorporated | 2016-03-28 |