| ACRYSOF INTRAOCULAR LENSES (P930014/S073) | Alcon Laboratories, Inc. | 2014-07-16 |
| COAPTITE INJECTABLE IMPLANT (P040047/S036) | Merz North America, Inc. | 2014-07-16 |
| URO VYSION BLADDER CANCER KIT (P030052/S015) | Abbott Molecular | 2014-07-16 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S006) | ABBOTT MEDICAL | 2014-07-16 |
| CAPSUREFIX NOVUS LEAD 4076, CAPSUREFIX NOVUS LEAD 5076 (P930039/S111) | Medtronic, Inc. | 2014-07-16 |
| CAPSUREFIX MRI SURESCAN LEAD 5086MRI (P090013/S146) | Medtronic, Inc. | 2014-07-16 |
| ACRYSOF IQ RESTOR (P040020/S054) | Alcon Research, Ltd. | 2014-07-16 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S024) | Dexcom, Inc. | 2014-07-16 |
| CAPSURE SENSE BIPOLAR LEAD 4074, CAPSURE SENSE BIPOLAR LEAD 4574 (P830061/S109) | Medtronic Cardiac Rhythm Disease Management | 2014-07-16 |
| PARADYM VR 8750, PARADYM DR 8750,PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101), PARADYM RF VR 9750, PARADYM RF DR 9750 (P980049/S100) | MicroPort CRM USA, Inc. | 2014-07-16 |
| PARADYM CRT-D 8750,PARADYM RF CRT-D 9750 (ZL101), PARADYM RF CRT-D (ZL102) (P060027/S067) | MicroPort CRM USA, Inc. | 2014-07-16 |
| VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S006) | Abbott Molecular, Inc. | 2014-07-16 |
| ADAPTA, VERSA, AND SENSIA IPG'S (P980035/S381) | Medtronic, Inc. | 2014-07-16 |
| MEDSTREAM PROGRAMMABLE INFUSION SYSTEM (P890055/S048) | Intera Oncology | 2014-07-15 |
| MOBI-C CERVICAL DISC PROSTHESIS (ONE LEVEL) (P110002/S005) | Highridge Medical, LLC | 2014-07-15 |
| MOBI-C CERVICAL DISC PROSTHESIS (TWO LEVELS) (P110009/S005) | Highridge Medical, LLC | 2014-07-15 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL (P060038/S020) | Corcym Canada Corp | 2014-07-15 |
| AFX BIFURCATED STENT GRAFT DELIVERY SYSTEM (P040002/S048) | Endologix, LLC | 2014-07-14 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S051) | Zoll Manufacturing Corporation | 2014-07-14 |
| INTELLATIP MIFI FILTER MODULE, INTELLATIP MIFI REFERENCE CABLE (P020025/S062) | Boston Scientific | 2014-07-14 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S015) | LeMaitre Vascular, Inc. | 2014-07-14 |
| PROTEGE NEUROSTIMULATION SYSTEM (P010032/S079) | ABBOTT MEDICAL | 2014-07-14 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S023) | Dexcom, Inc. | 2014-07-14 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S016) | OraSure Technologies, Inc. | 2014-07-11 |
| ADVISA DR IPG, ADVISA DR MRI IPG (P980035/S380) | Medtronic, Inc. | 2014-07-11 |
| SELOX, TILDA, SOLOX (P950037/S136) | Biotronik, Inc. | 2014-07-11 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S046) | Medtronic, Inc. | 2014-07-11 |
| GEM 21S (GROWTH-FACTOR ENHANCED MATRIX) (P040013/S018) | Lynch Biologics, LLC | 2014-07-11 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S241) | Medtronic, Inc. | 2014-07-11 |
| REVO MRI IPG (P090013/S144) | Medtronic, Inc. | 2014-07-11 |
| MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD AND MAXIMO VR ICD (P980016/S486) | Medtronic Cardiac Rhythm Disease Management | 2014-07-11 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S051) | Endologix, LLC | 2014-07-11 |
| NG3 ICDS, ORIGEN, INOGEN, DYNAGEN EL; NG2.5 ICDS -ORIGEN, INOGEN, DYNAGEN MINI ICDS (P960040/S321) | Boston Scientific | 2014-07-11 |
| NG3 CRT-D, DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4 (P010012/S360) | Boston Scientific Corp | 2014-07-11 |
| BAUSCH & LOMB PUREVISION2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES, BASUCH & LOMB PUREVISION2 MULTI-FOCAL (BALAFI (P980006/S022) | Bausch & Lomb, Inc. | 2014-07-11 |
| INSYNCC III MARQUIS ICD, INSYNC MAXIMO ICD (P010031/S448) | Medtronic Cardiac Rhythm Disease Management | 2014-07-11 |
| COROX, CELERITY (P070008/S052) | Biotronik, Inc. | 2014-07-11 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S200) | Boston Scientific Corp | 2014-07-11 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S055) | Medtronic, Inc. | 2014-07-11 |
| LIFE STENT VASCULAR STENT SYSTEM (P070014/S045) | Bard Peripheral Vascular, Inc. | 2014-07-11 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S019) | Dexcom, Inc. | 2014-07-11 |
| CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP ACCESSORIES, MEDSTREAM PROGRAMMABLE INFUSION SYSTEM (P890055/S057) | Intera Oncology | 2014-07-11 |
| LINOX SMART SD, VIGILA, VOLTA (P980023/S059) | Biotronik, Inc. | 2014-07-11 |
| SPRINT QUATTRO LEAD (P920015/S132) | Medtronic, Inc. | 2014-07-10 |
| SOF GLUCOSE SENSOR, SOF GLUCOSE SENSOR (MMT-7002, MMT-7003) (P980022/S154) | Medtronic Minimed | 2014-07-10 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S004) | Abbott Vascular (Idef Technologies Inc) | 2014-07-10 |
| PROMOTE, PROMOTE QUADRA, UNIFY, UNIFY QUADRA, UNIFY ASSURA AND QUADRA ASSURA FAMILIES OF CRT-D DEVICES (P030054/S271) | ABBOTT MEDICAL | 2014-07-10 |
| ENLITE GLUCOSE SENSOR, ENLITE GLUCOSE SENSOR (MMT-7008) (P120010/S021) | Medtronic, Inc. | 2014-07-10 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S022) | Dexcom, Inc. | 2014-07-10 |
| CURRENT, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILIES OF ICD DEVICE (P910023/S340) | ABBOTT MEDICAL | 2014-07-10 |
| ADVISA DR,ADVISA DR MRI (P980035/S358) | Medtronic, Inc. | 2014-07-09 |
| EVERA S DR ICD, EVERA S VR ICD; EVERA XT DR. ICD; EVERA XT VR IC D; MAXIMO II ICD; PROTECTA ICD' SECURA ICD, VIRTUOSO II (P980016/S488) | Medtronic Cardiac Rhythm Disease Management | 2014-07-09 |
| THE SOFTEC HD IOL (P090022/S023) | Lenstec, Inc. | 2014-07-09 |
| ANTHEM RFCRT-PS (P030035/S122) | ABBOTT MEDICAL | 2014-07-09 |
| MAXIMO II DR,MAXIMO II VR,VIRTUOSO II VR,SECURA DR,SECURA VR (P980016/S452) | Medtronic Cardiac Rhythm Disease Management | 2014-07-09 |
| EASYTRAK 2 IS-1 CORONARY VENOUS BIPOLAR PACE/SENSE LEADS (P010012/S362) | Boston Scientific Corp | 2014-07-09 |
| NEUROPACE RNS SYSTEM (P100026/S017) | NeuroPace, Inc. | 2014-07-09 |
| BRAVA CRT-D; CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D , PROTECTA CRT-D,PROTECTA XT CRT-D, VIVA S CRT-D, VIVA XT (P010031/S450) | Medtronic Cardiac Rhythm Disease Management | 2014-07-09 |
| AFX ENDOVASULAR AAA SYSTEM (P040002/S052) | Endologix, LLC | 2014-07-09 |
| VIVA CRT-P,CONSULTA CRT-P,SYNCRA CRT-P (P010015/S227) | Medtronic, Inc. | 2014-07-09 |
| CARELINK ENORE PROGRAMMER,CARELINK 2090 PROGRAMMER,CARELINK HOME MONITOR,CARELINK EXPRESS MONITOR,CARDIOSIGHT READER,DEV (P890003/S297) | Medtronic, Inc. | 2014-07-09 |
| FOCAL CATHETERS (P020045/S056) | Medtronic Cryocath, LP | 2014-07-09 |
| JUVEDERM ULTRA, JUVEDERM ULTRA PLUS, JUVEDERM ULTRA XC, JUVEDERM ULTRA PLUS XC (P050047/S039) | Allergan | 2014-07-09 |
| CONCERTO II CRT-D,MAXIMO II CRT-D,CONSULTA CRT-D,CONSULTA CRT-D DF4,MAXIMO II CRT-D DF4 (P010031/S414) | Medtronic Cardiac Rhythm Disease Management | 2014-07-09 |
| ACCENT SR RF, ACCENT DR RF PACEMAKERS (P880086/S244) | ABBOTT MEDICAL | 2014-07-09 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S004) | ABBOTT MEDICAL | 2014-07-09 |
| NEUROPACE RNS SYSTEM (P100026/S019) | NeuroPace, Inc. | 2014-07-09 |
| BALLOON CATHETER (P100010/S038) | Medtronic Cryocath, LP | 2014-07-09 |
| INCEPTA, ENERGEN, PUCTUA, COGNIS, DYANAGEN, INOGEN, ORIGEN CRT-DS (P010012/S358) | Boston Scientific Corp | 2014-07-08 |
| ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN (P090031/S002) | Anika Therapeutics, Inc. | 2014-07-08 |
| CAPSUREFIX MRI LEAD (P090013/S145) | Medtronic, Inc. | 2014-07-08 |
| ORTHOVISC HIGH MOLECULAR WEIGHT HYALURON (P030019/S020) | Anika Therapeutics, Inc. | 2014-07-08 |
| COOPERVISION COMFILCON A SOFT EXTENDED-WEAR CONTACT LENSES (P080011/S030) | CooperVision, Inc. | 2014-07-08 |
| CAPSUREFIX NOVUS LEAD (P930039/S110) | Medtronic, Inc. | 2014-07-08 |
| INCEPTA, ENERGEN, PUNCTUA, TELIGEN, VITALITY, DYNAGEN, INOGEN, ORIGEN ICDS (P960040/S319) | Boston Scientific | 2014-07-08 |
| PUNCTUA CRT-DS,COGNIS CRT-DS,ENERGEN CRT-DS,INCEPTA CRT-DS,ORIGEN CRT-DS,INOGEN CRT-DS,DYNAGEN CRT-DS (P010012/S361) | Boston Scientific Corp | 2014-07-08 |
| OPHTHALMICS- ANIKAVISC, OPTIVISC AND NUVISC (P000046/S025) | Anika Therapeutics, Inc. | 2014-07-08 |
| INSIGNIA, ALTRUA, INGENIO, ADVANTIO, VITALIO, FORMIO PACEMAKERS (N970003/S165) | Boston Scientific Corp | 2014-07-08 |
| INVIVE CRT-P, CONTAK RENEWAL TR CRT-P, INTUA CRT-P (P030005/S111) | Guidant Corp. | 2014-07-08 |
| ENDURANT AND ENDURANT II STENT GRAFT SYSTEM (P100021/S038) | Medtronic Vascular | 2014-07-08 |
| PUNCTUA ICDS,TELIGEN ICDS,ENERGEN ICDS,INCEPTA ICDS,ORIGEN ICDS,INOGEN ICDS,DYNAGEN ICDS (P960040/S322) | Boston Scientific | 2014-07-08 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S050) | Endologix, LLC | 2014-07-07 |
| EON MINI AND PROGEGE IMPLANTABLE NEUROSTIMULATION DEVICE (P010032/S078) | ABBOTT MEDICAL | 2014-07-07 |
| OXFORD PARTIAL KNEE SYSTEM (P010014/S048) | Biomet Manufacturing Corp | 2014-07-07 |
| MELAFIND (P090012/S009) | Strata Skin Sciences, Inc. | 2014-07-07 |
| ACCESS HYBRITECH P2PSA ON TH ACCESS IMMNUNOASSAY SYSTEM (P090026/S011) | Beckman Coulter, Inc. | 2014-07-07 |
| APTIMA HPV ASSAY (P100042/S003) | Gen-Probe Incorporated | 2014-07-07 |
| ITREL,RESTORE, SYNERGY SYSTEMS (P840001/S271) | Medtronic Neuromodulation | 2014-07-03 |
| INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE (P900033/S037) | Integra Lifesciences Corp. | 2014-07-03 |
| DRUG DELIVERY CATHETERS, DRUG DELIVERY KITS FOR REVISIONS (P990034/S032) | Medtronic, Inc. | 2014-07-03 |
| INTERSTIM SYSTEM (P970004/S177) | Medtronic Neuromodulation | 2014-07-03 |
| VIVA QUAD XT CRT-D,VIVA QUAD S CRT-D,BRAVA QUAD CRT-D,VIVA QUAD C CRT-D,VIVA/BRAVA/EVERA SOFTWARE APPLICATION (P010031/S442) | Medtronic Cardiac Rhythm Disease Management | 2014-07-03 |
| SYNCHROMED SYSTEM (P860004/S208) | Medtronic, Inc. | 2014-07-03 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM,XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S063) | Abbott Vascular | 2014-07-03 |
| PROTEGO FAMILY OF ICD LEADS (P980023/S057) | Biotronik, Inc. | 2014-07-03 |
| CARELINK MONITOR,CARDIOSIGHT READER,CARELINK EXPRESS,DEVICE DATA MANAGEMENT APPLICATION(DDMA) (P890003/S309) | Medtronic, Inc. | 2014-07-03 |
| ILESTO/IFORIA 5/7 VRT/DRT ICD'S, ILESTO/IFORIA 5/7 HF-T CRT-D (P050023/S076) | Biotronik, Inc. | 2014-07-03 |
| XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM- SV, AND LL (P110019/S068) | Abbott Vascular | 2014-07-03 |
| ACTIVA,KINETRA,SOLETRA SYSTEMS (P960009/S196) | Medtronic, Inc. | 2014-07-03 |
| INTERSTIM SYSTEM (P080025/S073) | Medtronic Neuromodulation | 2014-07-03 |