| BRAVIA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S358) | Medtronic Cardiac Rhythm Disease Management | 2013-03-07 |
| CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S002) | Boston Scientific Corporation | 2013-03-07 |
| CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D), PUNTUA CRT-D, COOGINS, ENERGEN CRT-D, INCEPTA CRT-D (P010012/S323) | Boston Scientific Corp | 2013-03-07 |
| ADVISA MRI (P980035/S308) | Medtronic, Inc. | 2013-03-07 |
| NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P990025/S031) | Biosense Webster, Inc. | 2013-03-07 |
| BLACKWELL BATTERY UBITS (UNIVERSAL BURN-IN TEST SYSTEM) (P010031/S354) | Medtronic Cardiac Rhythm Disease Management | 2013-03-07 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S004) | Torax Medical | 2013-03-07 |
| TECNIS 1-PIECE LENS (P980040/S042) | Johnson & Johnson Surgical Vision, Inc. | 2013-03-07 |
| PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBTILLATOR, TELIGEN IMPLANTABLE CARIOVERTER DEFIBRILLATOR, ENERGEN IMPLANTABLE CARDI (P960040/S288) | Boston Scientific | 2013-03-07 |
| PUNCTUA CRT-D, COGNIS CRT-D, ENERGEN CRT-D, INCEPTA CRT-D (P010012/S322) | Boston Scientific Corp | 2013-03-07 |
| BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S357) | Medtronic Cardiac Rhythm Disease Management | 2013-03-07 |
| NAVISTAR® THERMOCOOL® DIAGNOSTIC/ABLATION CATHETER AND CELSIUS® THERMOCOOL® DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P030031/S041) | Biosense Webster, Inc. | 2013-03-07 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S070) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2013-03-07 |
| CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P950005/S037) | Biosense Webster, Inc. | 2013-03-07 |
| NAVISTAR® AND CELSIUS® DS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS (P010068/S027) | Biosense Webster, Inc. | 2013-03-07 |
| PUNCTUA ICD, TELIGEN ICD, ENERGEN ICD, INCEPTA ICD (P960040/S287) | Boston Scientific | 2013-03-07 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S353) | Medtronic Cardiac Rhythm Disease Management | 2013-03-05 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STEN SYSTEM (P110010/S048) | Boston Scientific Corp | 2013-03-05 |
| UROLOGIX TARGIS SYSTEM (P970008/S063) | Urologix, LLC | 2013-03-05 |
| GLAUKOS TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L (P080030/S005) | Glaukos Corporation | 2013-03-05 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S021) | Boston Scientific Corporation | 2013-03-05 |
| VISTAKON (SENOFILCON A) (P040045/S037) | Vistakon, Division of Johnson & Johnson Vision Car | 2013-03-05 |
| VISTAKON (ETAFILCON A) (N18033/S069) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2013-03-05 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK (P010021/S024) | Ortho-Clinical Diagnostics, Inc. | 2013-03-05 |
| ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P100023/S070) | Boston Scientific Corp | 2013-03-05 |
| BRAVA/VIVA S/VIVA XT CRT-D (P010031/S356) | Medtronic Cardiac Rhythm Disease Management | 2013-03-05 |
| CARTOID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S013) | Boston Scientific Corp | 2013-03-05 |
| HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S039) | CooperSurgical, Inc. | 2013-03-05 |
| GLAUKOS TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L (P080030/S003) | Glaukos Corporation | 2013-03-05 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S005) | Medtronic | 2013-03-04 |
| SYNCHROMED II IMPLANTABLE PUMP, MODEL 8637 (P860004/S180) | Medtronic, Inc. | 2013-03-04 |
| ABBOTT REALTIME HCV (P100017/S004) | Abbott Molecular, Inc. | 2013-03-01 |
| PARADIGM REAL-TIME INSULIN PUMP (P980022/S132) | Medtronic Minimed | 2013-03-01 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S004) | Cook Ireland, Ltd. | 2013-03-01 |
| RESTYLANE INJECTABLE GEL (P040024/S068) | Q-Med AB | 2013-03-01 |
| ARTERX SURGICAL SEALANT (P100030) | Baxter Healthcare Corporation | 2013-03-01 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S349) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| DERMAGRAFT (P000036/S014) | Shire Regenerative Medicine | 2013-02-28 |
| ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II/PROTECTO/PROTECTO XT/SECURA/VIRTUOSO/VIRTUOSO II/PROTECTA XT DR/PROTECTA DR (P980016/S331) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS (P870056/S055) | Edwards Lifesciences, LLC | 2013-02-28 |
| UNIPOLAR/ LEAD END PIN CAP/OVAL PATCH LEAD (P900061/S111) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| ATTAIN/CONSULTA CRT-P/SYNCRA CRT-P (P010015/S148) | Medtronic, Inc. | 2013-02-28 |
| PRODIGY/SERVICE KIT-PACEMAKER REPAIR KIT (P890003/S240) | Medtronic, Inc. | 2013-02-28 |
| RESTYLANE INJECTABLE GEL (P040024/S066) | Q-Med AB | 2013-02-28 |
| VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM (P100040/S010) | Medtronic Vascular | 2013-02-28 |
| ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/VERSA (P980035/S253) | Medtronic, Inc. | 2013-02-28 |
| LEAD ADAPTOR/SPRINT QUATTRO/ SPRINT QUATTRO LEAD/SUBCUTANEOUS LEAD/TRANSVENE SVC LEAD (P920015/S084) | Medtronic, Inc. | 2013-02-28 |
| SELECTSECURE (P030036/S037) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S037) | Edwards Lifesciences, LLC | 2013-02-28 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S064) | Spectranetics Corp. | 2013-02-28 |
| CASURE/Z NOVUS/ VITATRON IMPULSE II (P850089/S085) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S351) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, RETROFLEX 3TM DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER, EDW (P100041/S018) | Edwards Lifesciences, LLC | 2013-02-28 |
| SELECTSECURE LEAD MODEL 3830 TECHNICAL MANUAL (P030036/S053) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| MEDTRONIC CAPSURE LEAD (P830061/S073) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S046) | Spectranetics (Philips) | 2013-02-28 |
| ATTAIN STARFIX (P060039/S031) | Medtronic, Inc. | 2013-02-28 |
| CARPENTIER-EDWARDS S.A.V AORTIC PORCINE BIOPROSTHESIS (P010041/S039) | Edwards Lifesciences, LLC | 2013-02-28 |
| REVO MRI (P090013/S047) | Medtronic, Inc. | 2013-02-28 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE (P870077/S050) | Edwards Lifesciences, LLC | 2013-02-28 |
| TRANSVENE CS/SVC LEAD (P980050/S068) | Medtronic, Inc. | 2013-02-28 |
| CARPENTIER-EDWARDS PERIMOUNT FAMILY OF PERICARDIAL BIOPROSTHESES (P860057/S098) | Edwards Lifesciences, LLC | 2013-02-28 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S038) | Medtronic, Inc. | 2013-02-28 |
| D286 CURRENT DRAIN LIMITS (P010031/S348) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| CONCERTO/CONCERTO II/INSYNC III MARQUIS/ INSYNC MAXIMO/MAXIMOII/PROTECTA/PROTECTA XT/PROTECTA CRT-D (P010031/S284) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER, EDWAR (P110021/S003) | Edwards Lifesciences, LLC | 2013-02-28 |
| ATTAIN ABILITY/ATTAIN ABILITY PLUS/ATTAIN ABILITY STRAIGHT (P080006/S036) | Medtronic, Inc. | 2013-02-28 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S355) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| BRAVA CRT-D, VIVA S CRT-D AND VIVA XT CRT-D (P010031/S352) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIC (P930039/S064) | Medtronic, Inc. | 2013-02-28 |
| RESTYLANE L AND PERLANE L INJECTABLE GEL (P040024/S065) | Q-Med AB | 2013-02-28 |
| VISTAKON (SENOFILCON A) (P040045/S036) | Vistakon, Division of Johnson & Johnson Vision Car | 2013-02-27 |
| PROPEL AND PROPEL MINI SINUS IMPLANT (P100044/S007) | Intersect Ent. | 2013-02-27 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S013) | Medtronic | 2013-02-27 |
| VISTAKON (ETAFILCON A) (N18033/S068) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2013-02-27 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S188) | Medtronic, Inc. | 2013-02-27 |
| PROTEGE GPS/RX CAROTID STENT SYSTEMS (P060001/S019) | Medtronic Vascular, Inc. | 2013-02-27 |
| ADVISA DR IPG, ADVISA MRI IPG (P980035/S306) | Medtronic, Inc. | 2013-02-27 |
| PRECISION SPINAL CORD STIMULATOR (SCS)SYSTEM (P030017/S153) | Boston Scientific Corp | 2013-02-26 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG (P980035/S305) | Medtronic, Inc. | 2013-02-26 |
| SOFTEC HDO (P090022/S015) | Lenstec, Inc. | 2013-02-26 |
| VNS THERAPY PULSE/PULSE DUO GENERATOR (P970003/S155) | LivaNova USA, Inc. | 2013-02-25 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S347) | Medtronic Cardiac Rhythm Disease Management | 2013-02-25 |
| DBS NEUROSTIMULATORS EXTERNAL, DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY (P960009/S164) | Medtronic, Inc. | 2013-02-25 |
| CURRENT+,EPIC II/EPIC II+, FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILY OF ICD DEVICES (P910023/S313) | ABBOTT MEDICAL | 2013-02-25 |
| PROMOTE+, UNIFY, UNIFY QUADRA, QUADRA ASSURA FAMILY OF CRT-D DEVICES (P030054/S243) | ABBOTT MEDICAL | 2013-02-25 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S346) | Medtronic Cardiac Rhythm Disease Management | 2013-02-25 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S030) | Coloplast Corp. | 2013-02-25 |
| SCS NEUROSTIMULATORS EXTERNAL, SCS NEUROSTIMULATORS IMPLANTABLE ITREL FAMILY, SCS NEUROSTIMULATORS IMPLANTABLE RESTORE (P840001/S233) | Medtronic Neuromodulation | 2013-02-25 |
| DRUG DELIVERY INFUSION PUMPS SYNCHROMED FAMILY (P860004/S186) | Medtronic, Inc. | 2013-02-25 |
| ARTEGRAFT COLLEGEN VASCULAR GRAFT (N16837/S010) | LeMaitre Vascular, Inc. | 2013-02-25 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S005) | Medtronic Vascular | 2013-02-22 |
| HER2 FISH PHARMADX KIT (P040005/S009) | Agilent Technologies Singapore (International) Pte , Ltd. | 2013-02-22 |
| H.E.L.P. PLASMAT FUTURA SYSTEM (P940016/S015) | B. Braun Avitum AG | 2013-02-22 |
| RADIESSE INJECTABLE IMPLANT (P050052/S038) | Merz North America, Inc. | 2013-02-22 |
| EPT-1000 XP RF ABLATION SYSTEM (P020025/S038) | Boston Scientific | 2013-02-22 |
| RADIESSE INJECTABLE IMPLANT (P050037/S035) | Merz North America, Inc. | 2013-02-22 |
| HERCAP TEST (P980018/S016) | Agilent Technologies Singapore (International) Pte , Ltd. | 2013-02-22 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S023) | Siemens Healthcare Diagnostics | 2013-02-22 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S055) | Boston Scientific Corp | 2013-02-22 |