| BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S418) | Medtronic Cardiac Rhythm Disease Management | 2014-02-04 |
| CAPSUREFIX NOVUS LEAD (P930039/S103) | Medtronic, Inc. | 2014-02-04 |
| CAPSUREFIX MRI LEAD (P090013/S127) | Medtronic, Inc. | 2014-02-04 |
| CAPSURE LEAD (P830061/S106) | Medtronic Cardiac Rhythm Disease Management | 2014-02-04 |
| COAPTITE INJECTABLE IMPLANT (P040047/S033) | Merz North America, Inc. | 2014-02-04 |
| ADAPTA, VERSA SENSIA IPG (P980035/S363) | Medtronic, Inc. | 2014-02-04 |
| EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD (P980016/S456) | Medtronic Cardiac Rhythm Disease Management | 2014-02-04 |
| ENDEAVOR SPRINT ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM (P060033/S086) | Medtronic, Inc. | 2014-02-03 |
| ARCHITECT FREE PSA (P980007/S033) | Abbott Laboratories | 2014-02-03 |
| DEXCOM G4® PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S002) | Dexcom, Inc. | 2014-02-03 |
| RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM (P110013/S033) | Medtronic Vascular | 2014-02-03 |
| ARCHITECT TOTAL PSA (P910007/S042) | Abbott Laboratories | 2014-02-03 |
| CAMERON HEALTH SUBCUTANCOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S025) | Boston Scientific Corporation | 2014-01-31 |
| QUANTIFERON -TB GOLD (P010033/S023) | Qiagen | 2014-01-31 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S037) | Edwards Lifesciences, LLC | 2014-01-31 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S024) | Edwards Lifesciences, LLC | 2014-01-31 |
| INTERSECT ENT PROPEL MINI SINUS IMPLANT (P100044/S012) | Intersect Ent. | 2014-01-31 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S020) | Boston Scientific Corporation | 2014-01-31 |
| RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM (P110013/S028) | Medtronic Vascular | 2014-01-30 |
| PERCLOSE PROGLIDE/PERCLOSE AT SUTURE MEDIATED CLOSURE SYSTEM (P960043/S086) | Abbott Vascular, Inc. | 2014-01-30 |
| ROTABLATOR ROTALINK ADVANCER AND ROTALINK PLUS (P900056/S130) | Boston Scientific Corp | 2014-01-30 |
| EXPRESS CORONARY STENT SYSTEM (P020009/S114) | Boston Scientific Scimed, Inc. | 2014-01-29 |
| THINPREP SLIDES (P950039/S027) | Hologic, Inc. | 2014-01-29 |
| PROSTALUND CORETHERM SYSTEM (P010055/S007) | Prostalund AB | 2014-01-29 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S053) | Boston Scientific Corp | 2014-01-29 |
| PERCLOSE PROGLIDE AND PERCLOSE AT 6F SUTURE MEDIATED CLOSURE SYSTEMS (P960043/S085) | Abbott Vascular, Inc. | 2014-01-29 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S030) | Boston Scientific Corporation | 2014-01-29 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S120) | Boston Scientific Scimed, Inc. | 2014-01-29 |
| PEARL 8.0 HANDPIECE (P970029/S025) | Cryolife, Inc. | 2014-01-28 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S002) | ABBOTT MEDICAL | 2014-01-28 |
| RT3 SURGICAL HEMOSTAT (P050044/S027) | Stryker Corp. | 2014-01-27 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047/S033) | Neomend, Inc. | 2014-01-27 |
| NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL CATHETER,EZ STEER THERMOCOOL CATHETER,EZ STEER THERMOCOOL NAV CATH (P040036/S041) | Biosense Webster, Inc. | 2014-01-24 |
| AFX VELA PROXIMAL ENDOGRAFT DELIVERY SYSTEM (P040002/S044) | Endologix, LLC | 2014-01-24 |
| NAVISTAR ,NAVISTAR RMT ,EZ STEER NAV CATHETERS AND,BIOSENSE WEBSTER CABLES (P990025/S039) | Biosense Webster, Inc. | 2014-01-24 |
| STAARVISC, OPTIVISC, AND ANIKAVISC SODIUM HYALURONATE (P000046/S021) | Anika Therapeutics, Inc. | 2014-01-24 |
| VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S004) | Abbott Molecular, Inc. | 2014-01-24 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S027) | Medtronic Vascular | 2014-01-24 |
| MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (P040044/S050) | Cordis US Corporation | 2014-01-24 |
| NEUROPACE RNS SYSTEM (P100026/S007) | NeuroPace, Inc. | 2014-01-24 |
| NAVISTAR RMT DS ,EZ STEER NAV DS ,CELSIUS FLTR, CELSIUS DS, & NAVISTAR DS CATHETERS (P010068/S038) | Biosense Webster, Inc. | 2014-01-24 |
| UROVYSION BLADDER CANCER KIT (P030052/S012) | Abbott Molecular | 2014-01-24 |
| OPEN PIVOT HEART VALVE AND AORTIC VALVE GRAFT (P990046/S037) | Medtronic Ats Medical, Inc. | 2014-01-24 |
| CELSIUS CATHETER,CELSIUS RMT CATHETER,EZ STEER CATHETER,EZ STEER DS CATHETER, DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS, (P950005/S049) | Biosense Webster, Inc. | 2014-01-24 |
| CELCIUS/ RMT THERMOCOOL ,NAVISTAR THERMOCOOL ,NAVISTAR RMT THERMOCOOL, THERMOCOOL, EZ STEER THERMOCOOL SF CATHETERS (P030031/S058) | Biosense Webster, Inc. | 2014-01-24 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROTHESIS,CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICA (P860057/S116) | Edwards Lifesciences, LLC | 2014-01-24 |
| BIOSENSE WEBSTER CABLES (P990071/S025) | Biosense Webster, Inc. | 2014-01-24 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0,COBAS AMPLIPREP/COBAS TAQMAN WASH REAGENT (P050028/S039) | Roche Molecular Systems, Inc. | 2014-01-23 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOP (P860057/S117) | Edwards Lifesciences, LLC | 2014-01-23 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROTHESIS (P870056/S064) | Edwards Lifesciences, LLC | 2014-01-23 |
| PATHWAY ANTI-HER-2/NEU (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S026) | Ventana Medical Systems, Inc. | 2014-01-23 |
| PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S013) | Ventana Medical Systems, Inc. | 2014-01-23 |
| DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOSTHESIS WITH EXTENDED RING (P870077/S058) | Edwards Lifesciences, LLC | 2014-01-23 |
| INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S015) | Ventana Medical Systems, Inc. | 2014-01-23 |
| SCULPTRA AND SCULPTRA AESTHETIC (INJECTABLE POLY-L-LACTIC ACID) (P030050/S019) | Q-Med AB | 2014-01-23 |
| CARPENTIER-EDWARDS SAV AORTIC PORCINE BIOPROSTHESIS (P010041/S047) | Edwards Lifesciences, LLC | 2014-01-23 |
| STAARVISC II, SHELLGEL (P000046/S022) | Anika Therapeutics, Inc. | 2014-01-23 |
| SPRINT QUATTRO LEADS, SPRINT FIDELIS (P920015/S122) | Medtronic, Inc. | 2014-01-22 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S187) | Boston Scientific Corp | 2014-01-22 |
| DBS SYSTEMS (P960009/S187) | Medtronic, Inc. | 2014-01-22 |
| INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S014) | Ventana Medical Systems, Inc. | 2014-01-22 |
| CAPSURE VDD-2 LEAD (P890003/S290) | Medtronic, Inc. | 2014-01-22 |
| REVO MRI IPG (P090013/S125) | Medtronic, Inc. | 2014-01-22 |
| CELSIUS FLTR CATHETER UNIDIRECTIONAL, CELSIUS FLTR CATHETER BIDIRECTIONAL (P950005/S047) | Biosense Webster, Inc. | 2014-01-22 |
| LIFESTENT VASCULAR STENT SYSTEM (P070014/S041) | Bard Peripheral Vascular, Inc. | 2014-01-22 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S047) | Zoll Manufacturing Corporation | 2014-01-22 |
| VECTRIS SURESCAN 1X8 LEADS (P840001/S259) | Medtronic Neuromodulation | 2014-01-22 |
| LCS TOTAL KNEE SYSTEM (P830055/S138) | Depuy, Inc. | 2014-01-22 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S024) | Boston Scientific Corporation | 2014-01-22 |
| SNS URINARY EXTENSIONS AND LEADS (P970004/S166) | Medtronic Neuromodulation | 2014-01-22 |
| SNS BOWEL EXTENSIONS (P080025/S062) | Medtronic Neuromodulation | 2014-01-22 |
| VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM (P100040/S012) | Medtronic Vascular | 2014-01-22 |
| CONSULTA CRT-P,SYNCRA CRT-P (P010015/S230) | Medtronic, Inc. | 2014-01-22 |
| COMPLETE SE VASCULAR STENT SYSTEM (P090006/S009) | Medtronic Vascular | 2014-01-22 |
| MEDSTREAM PROGRAMMABLE INFUSION SYSTEM (P890055/S053) | Intera Oncology | 2014-01-22 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S188) | Boston Scientific Corp | 2014-01-22 |
| CELSIUS FLTR CATHER UNIDIRECTIONAL,CELSIUS FLTR CATHETER BIDIRECTIONAL (P010068/S036) | Biosense Webster, Inc. | 2014-01-22 |
| BARD E-LUMINEXX VASCULAR STENT (P080007/S019) | Bard Peripheral Vascular, Inc. | 2014-01-22 |
| PATHWAY ANTI-HER-2/NEW (4B5)RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S025) | Ventana Medical Systems, Inc. | 2014-01-22 |
| ADAPTA,VERSA,SENSIA IPG, ADVISA DR IPG,ADVISA DR MRI IPG,RELIA IPG (P980035/S361) | Medtronic, Inc. | 2014-01-22 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S107) | Boston Scientific Corp | 2014-01-21 |
| NUCLEUS COCHLEAR IMPLANT SYSTEMS (P970051/S094) | Cochlear Americas | 2014-01-21 |
| COMBI 40+ COCHLEAR SYSTEM (P000025/S074) | Med-El Corp. | 2014-01-17 |
| LUMAX 3XO/5X10 (P050023/S073) | Biotronik, Inc. | 2014-01-17 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S035) | Coloplast Corp. | 2014-01-17 |
| HELISTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT HELITENE ABSORABLE COLLAGEN HEMOSTATIC AGENT FIBRILLAR FORM (P850010/S049) | Integra LifeSciences Corporation | 2014-01-17 |
| COLLASTAT , ABSORABLE COLLAGEN HEMOSTATIC SPONGE, INSTANT MCH MICROFIBRILLAR COLLAGEN HEMOSTAT (P810006/S050) | Integra LifeSciences Corporation | 2014-01-17 |
| COLLACOTE, COLLATAPE, COLLAPLUG, ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY (P840062/S037) | Integra Lifesciences Corp. | 2014-01-17 |
| MEDTRONIC COREVALVE SYSTEM (P130021) | Medtronic, Inc. | 2014-01-17 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S089) | W. L. Gore & Associates, Inc. | 2014-01-17 |
| LINOX (P980023/S054) | Biotronik, Inc. | 2014-01-17 |
| ETHICON OMNEX SURGICAL SEALANT (P060029/S005) | ETHICON, Inc. | 2014-01-17 |
| CAPSURE SENSE LEAD,CAPSURE SP NOVUS LEAD,VITATRON CRYSTALLINE LEAD,VITATRON EXCELLENCE PS+LEAD (P830061/S105) | Medtronic Cardiac Rhythm Disease Management | 2014-01-16 |
| TRANSVENE CS/SVC LEAD (P980050/S090) | Medtronic, Inc. | 2014-01-16 |
| CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD,VITATRON IMPULSE II LEAD (P850089/S105) | Medtronic Cardiac Rhythm Disease Management | 2014-01-16 |
| ADVISA DR IPG,ADVISA DR MRI IPG (P980035/S362) | Medtronic, Inc. | 2014-01-16 |
| ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P,SYNCRA CRT-P (P010015/S228) | Medtronic, Inc. | 2014-01-16 |
| BRAVA CRT-D; CONCERTO II CRT-D; CONSULTA ICD,MAXIMO II CRT-D, PROTECTA XI C RT-D, VIVA S/X CRT-D; (P010031/S415) | Medtronic Cardiac Rhythm Disease Management | 2014-01-16 |
| PERCLOSE PROGLIDE/PERCLOSE AT SUTURE MEDIATED CLOSURE SYSTEMS AND SNARED KNOT PUSHER (P960043/S083) | Abbott Vascular, Inc. | 2014-01-16 |
| DISPOSABLE EPG COVER; DUAL CHAMBER TEMPORARY PACEMANKER; SINGLE CHAMBER TEMPORARY PACEMAKER (P820003/S126) | Medtronic Cardiac Rhythm Disease Management | 2014-01-16 |