| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S016) | Boston Scientific Corp | 2013-07-09 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S114) | Boston Scientific Scimed, Inc. | 2013-07-09 |
| GENESYS HTA SYSTEM (P000040/S028) | Axora Medical, Inc. | 2013-07-09 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (P060008/S104) | Boston Scientific Corp | 2013-07-09 |
| PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S134) | Medtronic Minimed | 2013-07-08 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S034) | W. L. Gore & Associates, Inc. | 2013-07-05 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S017) | Edwards Lifesciences, LLC | 2013-07-03 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG AND RELIA IPG (P980035/S333) | Medtronic, Inc. | 2013-07-03 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S032) | Edwards Lifesciences, LLC | 2013-07-03 |
| ADAPTA,VERSA,SENSIA IPG (P980035/S332) | Medtronic, Inc. | 2013-07-03 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S018) | Edwards Lifesciences, LLC | 2013-07-03 |
| HEART WARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S022) | Medtronic | 2013-07-03 |
| SOFTEC HD, SOFTEC HD PS, SOFTEC I AND SOFTEC HDO DEVICES. (P090022/S018) | Lenstec, Inc. | 2013-07-03 |
| EVERA S DR ICD, EVER S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA IC (P980016/S422) | Medtronic Cardiac Rhythm Disease Management | 2013-07-03 |
| CAPSUREFIX MRI SURESCAN LEAD (P090013/S103) | Medtronic, Inc. | 2013-07-03 |
| COGNIS, INCEPTA, ENERGEN, PUNCTUA (P010012/S331) | Boston Scientific Corp | 2013-07-03 |
| BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S383) | Medtronic Cardiac Rhythm Disease Management | 2013-07-03 |
| TELIGEN, INCEPTA, ENERGEN, PUNCTUA (P960040/S296) | Boston Scientific | 2013-07-03 |
| INVIVE, INTUA (P030005/S100) | Guidant Corp. | 2013-07-03 |
| CAPSUREFIX NOVUS LEAD (P930039/S092) | Medtronic, Inc. | 2013-07-03 |
| CAPSURE SENSE BIPOLAR LEADS (P830061/S096) | Medtronic Cardiac Rhythm Disease Management | 2013-07-03 |
| ALAIR BRONCHIAL THERMOPLASTY SYSTEM (P080032/S012) | Boston Scientific Corp | 2013-07-03 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S031) | Edwards Lifesciences, LLC | 2013-07-03 |
| REVO MRI IPG (P090013/S104) | Medtronic, Inc. | 2013-07-03 |
| ADVANTIO, INGENIO, VITALIO, AND FORMIO (N970003/S153) | Boston Scientific Corp | 2013-07-03 |
| CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S014) | DePuy Orthopaedics, Inc. | 2013-07-02 |
| STRAUMANN ENDOGAIN, 0.15 ML, 075.099, STRAUMANN ENDOGAIN, 0.3 ML, 075.113, STRAUMANN ENDOGAIN, 0.7 ML, 075.115 (P930021/S013) | The Straumann Company | 2013-07-02 |
| BRAD E-LUMINEXX VASCULAR STENT SYSTEM (P080007/S017) | Bard Peripheral Vascular, Inc. | 2013-07-02 |
| ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN) (P050011/S004) | Baxter Healthcare Corp | 2013-07-02 |
| PROMETRA PROGRAMMABLE IMPLANTABLE PUMP (P080012/S016) | Infusyn Therapeutics, LLC | 2013-07-02 |
| RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM (P110013/S017) | Medtronic Vascular | 2013-07-02 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S015) | Boston Scientific Corp | 2013-07-02 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSAPICAL AND TRANSFEMORAL ACCESSORIES (P110021/S004) | Edwards Lifesciences, LLC | 2013-07-02 |
| AKREOS POSTERIOR CHAMBERS INTRAOCULAR LENS (P060022/S016) | Bausch & Lomb, Inc. | 2013-07-01 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S071) | Terumo Medical Corporation | 2013-07-01 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S148) | Boston Scientific Corp | 2013-06-28 |
| XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S039) | Abbott Vascular | 2013-06-28 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S006) | Dexcom, Inc. | 2013-06-28 |
| FLEXTONE CUTTING BALLOON, H7493BM3XXXXX, H749CBO3XXXXX (P950020/S055) | Boston Scientific Corp | 2013-06-28 |
| ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S086) | ABBOTT MEDICAL | 2013-06-28 |
| OPEN PIVOT HEART VALVE & OPEN PIVOTAORTIC VALVED GRAFT (P990046/S028) | Medtronic Ats Medical, Inc. | 2013-06-28 |
| SYNVISC AND SYNVISC-ONE (P940015/S027) | Sanofi Genzyme Corp. | 2013-06-28 |
| VITATRON C20 SR IPG,VITATRON C60 DR IPG,VITATRON T20 SR IPG (P990001/S114) | Medtronic, Inc. | 2013-06-27 |
| WAVESCAN WAVEFRONT SYSTEM (P930016/S038) | Amo Manufacturing USA, LLC | 2013-06-27 |
| ADAPTA,ADAPTAL,ADAPTA S,SENSIA L,SENSIA,VERSA IPG,RELIA IPG,SIGMA DR IPG,SIGMA S IPG (P980035/S331) | Medtronic, Inc. | 2013-06-27 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (XIENCE V EECSS,XIENCE V) (P070015/S112) | Abbott Vascular, Inc. | 2013-06-27 |
| AMO HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD),(3% SODIUM HYALURONATE) (P110007/S005) | Johnson & Johnson Surgical Vision, Inc. | 2013-06-27 |
| SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES(OVD),HEALON,HEALONGV,AND HEALON5 PRODUCTS (P810031/S048) | Johnson & Johnson Surgical Vision, Inc. | 2013-06-27 |
| AVITENE ULTRAFOAM MICROFIBRILLAR COLLAGEN HEMOSTAT SPONGE (N17600/S027) | Davol Inc., Sub. C. R. Bard, Inc. | 2013-06-27 |
| PRODIGY IPG (P890003/S279) | Medtronic, Inc. | 2013-06-27 |
| XIENCE PRIME EECSS (XIENCE PRIME AND XIENCE PRIME LONG LENGTHS [LL]) (P110019/S049) | Abbott Vascular | 2013-06-27 |
| WALLSTENT LLIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S038) | Boston Scientific Scimed, Inc. | 2013-06-26 |
| HELISTAT, HELITENE ABSORABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S041) | Integra LifeSciences Corporation | 2013-06-26 |
| REVO MRI IPG (P090013/S102) | Medtronic, Inc. | 2013-06-26 |
| ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (P110028/S008) | Abbott Vascular, Inc. | 2013-06-26 |
| CONCERTO ICD,CONCERTO II CRT-D,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAXIMO ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROT (P010031/S380) | Medtronic Cardiac Rhythm Disease Management | 2013-06-26 |
| COLLACOTE, COLLATAPE, COLLAPLUG, ABSORABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY (P840062/S030) | Integra Lifesciences Corp. | 2013-06-26 |
| INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO II ICD,MAXIMO VR ICD,PROTECTA ICD,PROTECTA XT ICD,SECUR (P980016/S420) | Medtronic Cardiac Rhythm Disease Management | 2013-06-26 |
| WALLSTENT (VENOUS) ENDOPROSTHESIS UNISTEP PLUS DELIVERY SYSTEM (P980033/S033) | Boston Scientific Corporation | 2013-06-26 |
| ADVISA DR IPG,ENRHYTHM IPG,SIGMA DR AND SIGMA S IPG,ADVISA DR MRI IPG (P980035/S330) | Medtronic, Inc. | 2013-06-26 |
| GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S050) | ABBOTT MEDICAL | 2013-06-26 |
| VITATRON C20 SR IPG,VITATRON C60 DR IPG,VITATRON T20 SR IPG,VITATRON T60 DR IPG (P990001/S113) | Medtronic, Inc. | 2013-06-26 |
| CAROTID EALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S014) | Boston Scientific Corp | 2013-06-26 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S030) | Integra Lifesciences Corp. | 2013-06-26 |
| COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR FORM (P810006/S043) | Integra LifeSciences Corporation | 2013-06-26 |
| WALLSTENT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S044) | Boston Scientific Corp | 2013-06-26 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S040) | Zoll Manufacturing Corporation | 2013-06-25 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, MITRAL BIOPROSTHESIS,; BIOPROSTHESIS VALVED CONDUIT; DURAFLEX LOW PRES (P870056/S059) | Edwards Lifesciences, LLC | 2013-06-25 |
| APLIGRAF (P950032/S073) | Organogenesis, Inc. | 2013-06-25 |
| ETI-CORE-IGMK PLUS (P990044/S015) | DiaSorin, Inc. | 2013-06-25 |
| OXFORD PARTIAL KNEE SYSTEM (P010014/S043) | Biomet Manufacturing Corp | 2013-06-25 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S030) | Edwards Lifesciences, LLC | 2013-06-25 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX (P100041/S029) | Edwards Lifesciences, LLC | 2013-06-25 |
| ETI-AB-EBK PLUS ASSAY (P990041/S017) | DiaSorin, Inc. | 2013-06-25 |
| ETI-MAK-2 PLUS ASSAY (P990038/S018) | DiaSorin, Inc. | 2013-06-25 |
| ENDURANT STENT GRAFT SYSTEM,ENDURANT II STENT GRAFT SYSTEM,ENDURANT II AORTO-UNI-ILIAC(AUI) STENT GRAFT SYSTEM (P100021/S026) | Medtronic Vascular | 2013-06-25 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S043) | Edwards Lifesciences, LLC | 2013-06-25 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX (P110021/S015) | Edwards Lifesciences, LLC | 2013-06-25 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S016) | Edwards Lifesciences, LLC | 2013-06-25 |
| ESTEEM (P090018/S021) | Envoy Medical Corporation | 2013-06-25 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, THEON PERICARDIAL AORTIC BIOPROSTHESIS, RSR PERICARDIAL (P860057/S109) | Edwards Lifesciences, LLC | 2013-06-25 |
| ROCHE COBAS HPV TEST (P100020/S004) | Roche Molecular Systems, Inc. | 2013-06-25 |
| ETI-AB-AUK PLUS ASSAY (P990042/S014) | DiaSorin, Inc. | 2013-06-25 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS; BIOPROSTHESIS-EDWARDS DURAFLEX LOW PRESSURE MITRA (P870077/S054) | Edwards Lifesciences, LLC | 2013-06-25 |
| ETI-EBK PLUS ASSAY (P990043/S018) | DiaSorin, Inc. | 2013-06-25 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S041) | Edwards Lifesciences, LLC | 2013-06-25 |
| ETI-AB-COREK PLUS (P990045/S015) | DiaSorin, Inc. | 2013-06-25 |
| COBAS TAQMAN HBV FOR USE WITH THE HIGH PURE SYSTEM (P050028/S033) | Roche Molecular Systems, Inc. | 2013-06-24 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.0 (P000012/S043) | Roche Molecular Systems, Inc. | 2013-06-24 |
| PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S018) | Infusyn Therapeutics, LLC | 2013-06-24 |
| EVERA S DR ICD , D VR ICD, ST DR ICD, XT VR ICD; MAXIMO II ICD, PROTECTA ICD/ XT ICD; SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S421) | Medtronic Cardiac Rhythm Disease Management | 2013-06-24 |
| BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D/ XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S382) | Medtronic Cardiac Rhythm Disease Management | 2013-06-24 |
| FREEZOR, FREEZOR XTRA AND FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE (P020045/S048) | Medtronic Cryocath, LP | 2013-06-21 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S104) | Boston Scientific Scimed, Inc. | 2013-06-21 |
| EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S043) | Boston Scientific Corp | 2013-06-21 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S053) | Thoratec Laboratories Corp. | 2013-06-21 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S110) | Boston Scientific Scimed, Inc. | 2013-06-21 |
| ION PACILITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S072) | Boston Scientific Corp | 2013-06-21 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S053) | W. L. Gore & Associates, Inc. | 2013-06-21 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S082) | W. L. Gore & Associates, Inc. | 2013-06-21 |