| RADIESSE, RADIESSE (+) (P050052/S065) | Merz North America, Inc. | 2015-11-12 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S284) | Medtronic, Inc. | 2015-11-12 |
| MEDTRONIC COREVALVE AND COREVALVE EVOLUT R SYSTEMS (P130021/S016) | Medtronic, Inc. | 2015-11-10 |
| INTERSTIM THERAPY SYSTEM (P970004/S206) | Medtronic Neuromodulation | 2015-11-10 |
| INTERSIM THERAPY SYSTEM (P080025/S101) | Medtronic Neuromodulation | 2015-11-10 |
| SYNCHROMED INFUSION SYSTEM (P860004/S240) | Medtronic, Inc. | 2015-11-10 |
| SYNCHROMED II PROGRAMMABLE PUMP (P860004/S185) | Medtronic, Inc. | 2015-11-09 |
| THERASCREEN KRAS RGQ PCR KIT (P110027/S009) | QIAGEN GmbH | 2015-11-09 |
| APTIMA HPV ASSAY (P100042/S009) | Gen-Probe Incorporated | 2015-11-09 |
| THERASCREEN EGFR RGQ PCR KIT (P120022/S012) | QIAGEN GmbH | 2015-11-09 |
| APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S007) | Gen-Probe Incorporated | 2015-11-09 |
| INNOVA (TM) VASCULAR SELF EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S004) | Boston Scientific Corporation | 2015-11-09 |
| EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS (P790005/S052) | Ahp Eos Buyer, Inc. | 2015-11-06 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S063) | Zoll Manufacturing Corporation | 2015-11-06 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S054) | Zoll Manufacturing Corporation | 2015-11-06 |
| RESTYLANE, RESTYLANE-L, RESTYLANE LYFT, RESTYLANE SILK, PERLANE (P040024/S087) | Q-Med AB | 2015-11-06 |
| SPF- XL IIB IMPLANTABLE SPINAL FUSION STIMULATORS & SPF PLUS MINI SPINAL FUSION STIMULATORS (P850035/S039) | Ahp Eos Buyer, Inc. | 2015-11-06 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S053) | Zoll Manufacturing Corporation | 2015-11-06 |
| BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES (P080011/S040) | CooperVision, Inc. | 2015-11-06 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S059) | Zoll Manufacturing Corporation | 2015-11-06 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S038) | Dexcom, Inc. | 2015-11-06 |
| BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM; SPINAL PAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM (P850022/S026) | Ahp Eos Buyer, Inc. | 2015-11-06 |
| BIOFINITY XR TORIC (P080011/S039) | CooperVision, Inc. | 2015-11-06 |
| EON, EONC, EON MINI PROTEGE, PROTEGE MRI IMPLANTABLE PULSE GENERATORS (IPG'S) (P010032/S105) | ABBOTT MEDICAL | 2015-11-06 |
| BIOMET EBI BONE HEALING SYSTEM (P790002/S033) | Ahp Eos Buyer, Inc. | 2015-11-06 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S064) | Zoll Manufacturing Corporation | 2015-11-06 |
| BRIO SYSTEMS (P140009/S006) | ABBOTT MEDICAL | 2015-11-06 |
| GENESIS/EON/EONC/EON MINI/PROTEGE SYSTEMS (P010032/S104) | ABBOTT MEDICAL | 2015-11-06 |
| BRIO IMPLANTABLE PULSE GENERATORS (IPG'S) (P140009/S007) | ABBOTT MEDICAL | 2015-11-06 |
| ENDO RELIANCE/ S/G/SG/DF4 DEFIBRILLATION LEADS (P910073/S122) | Boston Scientific | 2015-11-06 |
| THERMOCOOL SMARTTOUCH (P040036/S053) | Biosense Webster, Inc. | 2015-11-05 |
| TRIDENT (P000013/S012) | Howmedica Osteonics Corp. | 2015-11-05 |
| NEUROPACE RNS SYSTEM (P100026/S038) | NeuroPace, Inc. | 2015-11-05 |
| CELSIUS DS (P950005/S059) | Biosense Webster, Inc. | 2015-11-05 |
| CORDIS S.M.A.R.T. AND S.M.A.R.T. CONTROL VASCULAR STENT SYSTEM (P120002/S011) | Cordis US Corporation | 2015-11-05 |
| NAVISTAR (P990025/S047) | Biosense Webster, Inc. | 2015-11-05 |
| CELSIUS THERMOCOOL, THERMOCOOL SF, NAVISTAR THERMOCOOL, THERMOCOOL SF NAV, THERMOCOOL SMARTTOUCH (P030031/S071) | Biosense Webster, Inc. | 2015-11-05 |
| CELSIUS, CELSIUS FLTR, NAVISTAR DS (P010068/S049) | Biosense Webster, Inc. | 2015-11-05 |
| TECHNOLAS 217A EXCIMER LASER SYSTEM FOR LASER IN-SITU KERATOMILEUSIS(LASIK), TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALI (P990027/S020) | Technolas Perfect Vision GmbH | 2015-11-05 |
| EXTERNAL PULSE GENERATOR, 2 PORT HEADER (P010032/S103) | ABBOTT MEDICAL | 2015-11-05 |
| CORDIS S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036/S035) | Cordis US Corporation | 2015-11-05 |
| SOFPORT/SOFLEX INTRAOCULAR LENSES (P910061/S022) | Bausch & Lomb | 2015-11-05 |
| MY CARE-LINK SMART MONITOR PATIENT READER (P890003/S340) | Medtronic, Inc. | 2015-11-04 |
| HANCOCK LOW POROSITY VALVED CONDUIT (P870078/S030) | Medtronic, Inc. | 2015-11-04 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S061) | Medtronic, Inc. | 2015-11-04 |
| ACTIVL ARTIFICIAL DISC (P120024/S002) | Highridge Medical, LLC | 2015-11-04 |
| EMBLEM S-ICD PULSE GENERATOR (P110042/S053) | Boston Scientific Corporation | 2015-11-04 |
| HANCOCK MODIFIED ORIFICE VALUED CONDUIT (P790007/S046) | Medtronic Heart Valves | 2015-11-04 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S052) | Medtronic, Inc. | 2015-11-04 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S051) | Medtronic, Inc. | 2015-11-04 |
| SYNCHROMED INFUSION SYSTEM (P860004/S239) | Medtronic, Inc. | 2015-11-04 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S211) | Medtronic, Inc. | 2015-11-04 |
| IMPELLA 2.5 SYSTEM (P140003/S006) | Abiomed, Inc. | 2015-11-03 |
| ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE PACEMAKERS (N970003/S182) | Boston Scientific Corp | 2015-11-03 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S045) | ABBOTT MEDICAL | 2015-11-03 |
| I-FACTOR PEPTIDE ENHANCED BONE GRAFT (P140019) | Cerapedics, LLC | 2015-11-03 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CALIBRATOR (P030026/S031) | Ortho-Clinical Diagnostics, Inc. | 2015-11-03 |
| ANIMAL VIBE SYSTEM (P130007/S008) | Animas Corp. | 2015-11-03 |
| HYDRELLE DERMAL FILLER (P050033/S018) | Anika Therapeutics, Inc. | 2015-11-03 |
| VALITUDE (MODEL U125), VALITUDE X4 (MODEL U128) CRT-PS (P030005/S129) | Guidant Corp. | 2015-11-03 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S034) | Syncardia Systems, LLC | 2015-11-02 |
| GENESIS PROGRAMMER, EON PATIENT PROGRAMMER, PROTEGE PROGRAMMER, PATIENT PROGRAMMER (MRI) (P010032/S098) | ABBOTT MEDICAL | 2015-11-02 |
| PROCLAIM NEUROSTIMULATION SYSTEM (P010032/S096) | ABBOTT MEDICAL | 2015-11-02 |
| BRIO PATIENT PROGRAMMER (P140009/S002) | ABBOTT MEDICAL | 2015-11-02 |
| THERAKOS CELLEX PHOTOSPHERESIS SYSTEM INSTRUMENT (P860003/S081) | Therakos Development Limited | 2015-11-02 |
| ANGIOJET ULTRA THROMBECTOMY SYSTEM CONSOLE (P980037/S050) | Boston Scientific Corp | 2015-11-02 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S112) | Boston Scientific Corp | 2015-10-30 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S239) | Medtronic, Inc. | 2015-10-30 |
| ANIMAS VIBE SYSTEM (P130007/S003) | Animas Corp. | 2015-10-30 |
| RESTORE,ITREL SPINAL CORD STIMULATION SYSTEMS (P840001/S314) | Medtronic Neuromodulation | 2015-10-30 |
| INTERSTIM THERAPY SYSTEM (P080025/S100) | Medtronic Neuromodulation | 2015-10-30 |
| VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S021) | Medtronic Vascular | 2015-10-30 |
| INTERSTIM THERAPY SYSTEM (P970004/S205) | Medtronic Neuromodulation | 2015-10-30 |
| OXFORD PARTIAL KNEE SYSTEM (P010014/S052) | Biomet Manufacturing Corp | 2015-10-30 |
| CAPSUREFIX LEAD (P930039/S141) | Medtronic, Inc. | 2015-10-30 |
| SYNCHROMED INFUSION SYSTEM (P860004/S238) | Medtronic, Inc. | 2015-10-30 |
| SPRINT QUATTRO LEAD (P920015/S165) | Medtronic, Inc. | 2015-10-30 |
| ANGIOJET ULTRA XMI, SPIROFLEX, SPIROFLEX VG, DISTAFLEX THROMBECTOMY SETS (P980037/S049) | Boston Scientific Corp | 2015-10-30 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S511) | Medtronic Cardiac Rhythm Disease Management | 2015-10-29 |
| UROLOGIX TARGIS SYSTEM (P970008/S065) | Urologix, LLC | 2015-10-29 |
| PROTEGO DF-1 LEAD FAMILY (P980023/S070) | Biotronik, Inc. | 2015-10-29 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S548) | Medtronic Cardiac Rhythm Disease Management | 2015-10-29 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S014) | ABBOTT MEDICAL | 2015-10-29 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S035) | Syncardia Systems, LLC | 2015-10-29 |
| BRAVA CRT-D,BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D, EVERA MRI ICD (P010031/S516) | Medtronic Cardiac Rhythm Disease Management | 2015-10-29 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S554) | Medtronic Cardiac Rhythm Disease Management | 2015-10-29 |
| RADIESSE INJECTABLE IMPLANT FOR SUB-DERMAL IMPLANTATION FOR RESTORATION AND OR CORRECTION FOR THE SIGNS OF FACIAL FAT LO (P050037/S056) | Merz North America, Inc. | 2015-10-28 |
| COAPTITE INJECTABLE IMPLANT (P040047/S038) | Merz North America, Inc. | 2015-10-28 |
| RADIESSE, RADIESSE (+), RADIESSE WITH LIDOCAINE INJECTABLE IMPLANT (P050052/S062) | Merz North America, Inc. | 2015-10-28 |
| PROPEL AND PROPEL MINI SINUS IMPLANTS (P100044/S019) | Intersect Ent. | 2015-10-28 |
| VNS THERAPY SYSTEM, VNS THERAPY PROGRAMMING SOFTWARE (V11.0.4) (P970003/S183) | LivaNova USA, Inc. | 2015-10-28 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM. (P010013/S066) | Hologic, Inc. | 2015-10-27 |
| ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM (P060037/S040) | Zimmer, Inc. | 2015-10-27 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO (P860057/S139) | Edwards Lifesciences, LLC | 2015-10-27 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S041) | Edwards Lifesciences, LLC | 2015-10-27 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S016) | Cook Ireland, Ltd. | 2015-10-26 |
| BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA QUAD S CRT-D, (P010031/S515) | Medtronic Cardiac Rhythm Disease Management | 2015-10-23 |
| REVO MRI SURESCAN IPG (P090013/S203) | Medtronic, Inc. | 2015-10-23 |
| TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM (P070027/S046) | Medtronic Vascular | 2015-10-23 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG (P980035/S440) | Medtronic, Inc. | 2015-10-23 |