| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S113) | Boston Scientific Scimed, Inc. | 2013-09-05 |
| CELCIUS THERMOCOOL CATHETER,CELCIUS RMT THERMOCOOL CATHETER,NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL CATHETE (P030031/S055) | Biosense Webster, Inc. | 2013-09-05 |
| ACCENT DR RF,ACCENT SR RF PACEMAKER DEVICES (P880086/S234) | ABBOTT MEDICAL | 2013-09-05 |
| CARELINK PROGRAMMER MODEL 2090 AND MODEL 9790/C PROGRAMMER (P890003/S260) | Medtronic, Inc. | 2013-09-05 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S039) | Boston Scientific Corp | 2013-09-04 |
| T-SPOT .TB TEST (P070006/S011) | Oxford Immunotec, Ltd. | 2013-09-03 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S432) | Medtronic Cardiac Rhythm Disease Management | 2013-09-03 |
| BRAVA CRT-D, VIVA S CRT-D AND VIVA XT CRT-D (P010031/S393) | Medtronic Cardiac Rhythm Disease Management | 2013-09-03 |
| IMPLANTABLE MINIATURE WIDE ANGLE 2.2XAND WIDE ANGLE 2.7X (P050034/S011) | Samsara Vision, Inc. | 2013-09-03 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S021) | Medtronic | 2013-08-30 |
| INFUSE BONE GRAFT (P050053/S023) | Medtronic, Inc. | 2013-08-30 |
| INFUSE BONE GRAFT/LT CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S047) | Medtronic Sofamor Danek USA, Inc. | 2013-08-30 |
| REFLECTION CERAMIC HIP SYSTEM (P030022/S025) | Smith & Nephew, Inc. | 2013-08-30 |
| HEART WARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S023) | Medtronic | 2013-08-30 |
| REPLY SR, REPLY DR, ESPRIT DR (P950029/S082) | MicroPort CRM USA, Inc. | 2013-08-30 |
| ARCHITECT ANTI-HCV LN 1L79 (P050042/S025) | Abbott Laboratories, Inc. | 2013-08-30 |
| INFUSE BONE GRAFT (P000054/S032) | Medtronic Sofamor Danek USA, Inc. | 2013-08-30 |
| LAP-BAND ADJUSTABLE GASTRIC BAND (P000008/S027) | Medtimo, Inc. | 2013-08-29 |
| COLLACOTE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY (P840062/S031) | Integra Lifesciences Corp. | 2013-08-29 |
| OLYMPIC COOL CAP (P040025/S013) | Natus Medical Incorporated | 2013-08-29 |
| PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM (P960043/S082) | Abbott Vascular, Inc. | 2013-08-29 |
| INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE (P900033/S031) | Integra Lifesciences Corp. | 2013-08-29 |
| INTEGRITY OVER-THE-WIRE CORONARY STENT SYSTEMS (P030009/S066) | Medtronic, Ireland | 2013-08-29 |
| COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT, MICROFIBRILLAR FORM (P810006/S044) | Integra LifeSciences Corporation | 2013-08-29 |
| SAFIRE DUO/COOL PATH DUO ABLATION CATHETERS, VERISENSE ENABLED AND VERISENSE SYSTEM AND IBI 1500T9-CP V1.6 CARDIAC (P110016/S007) | ABBOTT MEDICAL | 2013-08-29 |
| HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S042) | Integra LifeSciences Corporation | 2013-08-29 |
| RESOLUTE INTEGRITY OVER-THE-WIRE ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S023) | Medtronic Vascular | 2013-08-29 |
| THERAKOS CELLEX INSTRUMENT,PHOTOPHERESIS PROCEDURAL KIT,AND LIGHT ASSEMBLY (P860003/S074) | Therakos Development Limited | 2013-08-28 |
| HER2 IQFISH PHARMDX (P040005/S010) | Agilent Technologies Singapore (International) Pte , Ltd. | 2013-08-28 |
| GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S010) | Glaukos Corporation | 2013-08-28 |
| THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S011) | Srs Medical | 2013-08-28 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S009) | Boston Scientific Corporation | 2013-08-28 |
| ICD DEVICES (P910023/S320) | ABBOTT MEDICAL | 2013-08-28 |
| LCS TOTAL KNEE SYSTEM (P830055/S136) | Depuy, Inc. | 2013-08-28 |
| O2OPTIX, AIR OPTRIX AQUA, AIR OPTIX FOR ASTIGMATISM ; AIR OPTIX AQUA MULTIFOCAL (P010019/S035) | Alcon Laboratories, Inc. | 2013-08-28 |
| CRT- D DEVICES (P030054/S252) | ABBOTT MEDICAL | 2013-08-28 |
| HER2 CISH PHARMDX KIT (P100024/S005) | Dako Denmark A/S | 2013-08-28 |
| CHILLI II COOL ABLATION CATHETER (P980003/S038) | Boston Scientific Corp | 2013-08-28 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S022) | Medtronic Vascular | 2013-08-28 |
| ESTEEM (P090018/S023) | Envoy Medical Corporation | 2013-08-27 |
| CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S017) | DePuy Orthopaedics, Inc. | 2013-08-27 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S113) | Abbott Vascular, Inc. | 2013-08-27 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORNARY STENT SYSTEM (P110019/S051) | Abbott Vascular | 2013-08-27 |
| EXTERNAL NEUROSTIMULATOR, ITREL 4 PROGRAMMABLE NEUROSTIMULATOR FOR SPINAL CORD STIMULATION,RESTOREPRIME NEUROSTIMULATOR, (P840001/S246) | Medtronic Neuromodulation | 2013-08-27 |
| TRIVASCULAR, INC. OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S004) | Endologix, LLC | 2013-08-27 |
| SYNCHROMED II INFUSION PUMP (P860004/S194) | Medtronic, Inc. | 2013-08-27 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S009) | Abbott Vascular, Inc. | 2013-08-27 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S052) | Abbott Vascular | 2013-08-27 |
| EXTERNAL NEUROSTIMULATOR,ACTIVIA PC NEUROSTIMULATOR,ACTIVIA SC NEUROSTIMULATOR,ACTIVA RC NEUROSTIMULATOR (P960009/S178) | Medtronic, Inc. | 2013-08-27 |
| ACTIVA DBS LEAD, ACTIVA DBS LEAD REDUCED SPACING (P960009/S177) | Medtronic, Inc. | 2013-08-27 |
| BELLAFILL (P020012/S008) | Tiger Aesthetics Medical, LLC | 2013-08-27 |
| ARCHITECT AFP ASSAY (P120008/S002) | Abbott Laboratories | 2013-08-27 |
| PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S130) | Medtronic Minimed | 2013-08-26 |
| AFX ENDOVASCULAR AAA DELIVERY SYSTEM (P040002/S042) | Endologix, LLC | 2013-08-26 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S111) | Cochlear Americas | 2013-08-26 |
| GORE EXCLUDER AAA ENDOPROSATHESIS WITH C3 DELIVERY SYSTEM (P020004/S085) | W. L. Gore & Associates, Inc. | 2013-08-26 |
| COLLACOLE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY (P840062/S032) | Integra Lifesciences Corp. | 2013-08-23 |
| MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) (P110009) | Highridge Medical, LLC | 2013-08-23 |
| HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S043) | Integra LifeSciences Corporation | 2013-08-23 |
| GEL-ONE (P080020/S005) | Seikagaku Corp. | 2013-08-23 |
| PARADIGUM REAL TIME PUMP; PARADIGUM REAL TIME REVEL INSULIN PUMP (P980022/S135) | Medtronic Minimed | 2013-08-23 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM (P810006/S045) | Integra LifeSciences Corporation | 2013-08-23 |
| PATHWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S021) | Ventana Medical Systems, Inc. | 2013-08-22 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S211) | Medtronic, Inc. | 2013-08-22 |
| ADAPTA, VERSA, SENSIA IPG; ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S340) | Medtronic, Inc. | 2013-08-22 |
| EZ STEER THERMOCOOL NAV (P040036/S038) | Biosense Webster, Inc. | 2013-08-22 |
| INTUA (P030005/S101) | Guidant Corp. | 2013-08-22 |
| CERVISTA HPV HR ASSAY (P080014/S017) | Hologic, Inc. | 2013-08-22 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S011) | Medtronic Vascular | 2013-08-22 |
| BRAVA CRT-D, CONCERTO II CRT-D, COSULTA ICD, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D, PROTECTA CRT-D (P010031/S391) | Medtronic Cardiac Rhythm Disease Management | 2013-08-22 |
| VITATRON C20 SR IPG; C60 DR IPG; T20 SR IPG; T60 DR IPG (P990001/S115) | Medtronic, Inc. | 2013-08-22 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S013) | Boston Scientific Corporation | 2013-08-22 |
| REVO MRI IPG (P090013/S109) | Medtronic, Inc. | 2013-08-22 |
| LIVEWIRE TC ABLATION CATHETER (P960016/S041) | St Jude Medical | 2013-08-22 |
| ZILVER VASCULAR STENT (P050017/S008) | Cook Ireland, Ltd. | 2013-08-22 |
| PARASCRIPT ACCUDETECT 6.1.0 (P120004) | Parascript, LLC | 2013-08-22 |
| EVERA S DR ICD, S VR ICD, XT DR ICD, XT VR ICD; INTRINSIC ICD; MARQUIS DR ICD, VR ICD; MAXIMO DR ICD, MAXIMO II ICD, MAX (P980016/S430) | Medtronic Cardiac Rhythm Disease Management | 2013-08-22 |
| PRODIGY IPG (P890003/S282) | Medtronic, Inc. | 2013-08-22 |
| EXPRESS LD ILLIAC PEMOUNTED STENT SYSTEM (P090003/S026) | Boston Scientific Corporation | 2013-08-22 |
| Y ADAPTOR/EXTENDER KIT, HV SPLITTER/ ADAPTOR KIT (P920015/S114) | Medtronic, Inc. | 2013-08-22 |
| VITALIO, FORMIO (N970003/S154) | Boston Scientific Corp | 2013-08-22 |
| BRAVA,VIVA S,VIVA XT CRT-DS (P010031/S390) | Medtronic Cardiac Rhythm Disease Management | 2013-08-22 |
| COLLAMER VISIAN IMPLANTABLE COLLAMER LENS MICL (P030016/S025) | STAAR Surgical Company | 2013-08-22 |
| NAVISTAR THERMOCOOL (P030031/S054) | Biosense Webster, Inc. | 2013-08-22 |
| ATTAIN ABILITY LEADS (P080006/S056) | Medtronic, Inc. | 2013-08-22 |
| EVERA S DR,EVERA S VR,EVERA XT DR,EVERA XT VR ICDS (P980016/S429) | Medtronic Cardiac Rhythm Disease Management | 2013-08-22 |
| CVX-300 AND CVX-300-P EXCIMER LASER SYSTEMS (P910001/S066) | Spectranetics Corp. | 2013-08-21 |
| ZOOM LATITUDE PROGRAMMER (P910077/S136) | Boston Scientific | 2013-08-21 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST,V2.0,; HIGH PURE/COBAS TAQMAN HCV V20.3 TEST (P060030/S033) | Roche Molecular Systems, Inc. | 2013-08-21 |
| TECNIS ITEC PRELOADED DELIVERY SYSTEM (P980040/S041) | Johnson & Johnson Surgical Vision, Inc. | 2013-08-21 |
| DEXCOM G4 PLATINUM CONTINOUS GLUCOSE MONITORING SYSTEM (P120005/S008) | Dexcom, Inc. | 2013-08-21 |
| ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S019) | Spectranetics Corp. | 2013-08-21 |
| COBAS AMPLIPREP/CONAS TAQMAN CMV TEST (P110037/S007) | Roche Molecular Systems, Inc. | 2013-08-21 |
| COBAS 4800 BRAF V600 MUTATION TEST (P110020/S007) | Roche Molecular Systems, Inc. | 2013-08-21 |
| FEMCAP (P020041/S003) | Femcap Incorporated | 2013-08-21 |
| OXFORD PARTIAL KNEE SYSTEM (P010014/S045) | Biomet Manufacturing Corp | 2013-08-21 |
| COBAS EGFR MUTATION TEST (P120019/S001) | Roche | 2013-08-21 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S176) | Boston Scientific Corp | 2013-08-21 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S057) | Boston Scientific Corp | 2013-08-21 |
| SOFPORT POSTERIOR CHAMBER INTRAOCULAR LENS (P910061/S020) | Bausch & Lomb | 2013-08-21 |