| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S005) | Edwards Lifesciences, LLC | 2013-06-11 |
| CONCERTO, RIGHT VENTRICULAR LEAD INTEGRITY ALERT, CONCERTO-II CRT-D, CONSULTA CRT-D, INSYNC ICD, INSYNC II MARQUIS, INSY (P010031/S373) | Medtronic Cardiac Rhythm Disease Management | 2013-06-11 |
| ENTRUST,GEM,GEM II,GEM III,INTRINSIC,MARQUIS,MAXIMO,MAXIMO II,ONYX,PROTECTA DF4,PROTECTA,PROTECTA XT DF4,PROTECTA XT (P980016/S413) | Medtronic Cardiac Rhythm Disease Management | 2013-06-11 |
| REVO MRI AND ENRHYTHM MRI (P090013/S093) | Medtronic, Inc. | 2013-06-11 |
| VITATRON (IPG'S) (P990001/S111) | Medtronic, Inc. | 2013-06-11 |
| CURRENT+, FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILIES OF ICD DEVICES (P910023/S319) | ABBOTT MEDICAL | 2013-06-11 |
| CONSULTA CRT-P INSYNC, INSYNC III, SYNCRA CRT-P AND CONCERTO (P010015/S198) | Medtronic, Inc. | 2013-06-11 |
| PROMOTE+, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY, UNIFY QUADRA, QUADRA ASSURA FAMI LIES OF CRT-D DEVICES (P030054/S251) | ABBOTT MEDICAL | 2013-06-11 |
| LCS TOTAL KNEE SYSTEM (P830055/S134) | Depuy, Inc. | 2013-06-11 |
| XACT CAROTID STENT SYSTEM (P040038/S029) | Abbott Vascular, Inc. | 2013-06-11 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S038) | Edwards Lifesciences, LLC | 2013-06-11 |
| INTEGRA ARTIFICIAL SKIN REGENERATION TEMPLATE (P900033/S029) | Integra Lifesciences Corp. | 2013-06-10 |
| HELISTAT, HELITENE ABSORABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S035) | Integra LifeSciences Corporation | 2013-06-10 |
| COLLACOTE, COLLATAPE, COLLAPLUG ABSORABLE COLLAGEN WOUND DRESSINGS FOR DENTAL (P840062/S027) | Integra Lifesciences Corp. | 2013-06-10 |
| PROPEL MINI SINUS IMPLANTS (P100044/S006) | Intersect Ent. | 2013-06-10 |
| COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM (P810006/S038) | Integra LifeSciences Corporation | 2013-06-10 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, PERIMOUNT THEON PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S108) | Edwards Lifesciences, LLC | 2013-06-10 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM (P110021/S014) | Edwards Lifesciences, LLC | 2013-06-10 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM (P100041/S028) | Edwards Lifesciences, LLC | 2013-06-10 |
| COAPTITE INJECTABLE IMPLANT (P040047/S026) | Merz North America, Inc. | 2013-06-07 |
| COBAS AMPLICOR HCV TEST V2.0,COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S042) | Roche Molecular Systems, Inc. | 2013-06-07 |
| OPEN PIVOT HEART VALVE (P990046/S032) | Medtronic Ats Medical, Inc. | 2013-06-07 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S033) | Beckman Coulter, Inc. | 2013-06-07 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S023) | Beckman Coulter, Inc. | 2013-06-07 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S022) | Beckman Coulter, Inc. | 2013-06-07 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S108) | Abbott Vascular, Inc. | 2013-06-07 |
| ARCTIC FRONT AND ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETERS (P100010/S022) | Medtronic Cryocath, LP | 2013-06-07 |
| ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S006) | Beckman Coulter, Inc. | 2013-06-07 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S084) | St. Jude Medical, Inc. | 2013-06-06 |
| MED-EL COCHLEAR IMPLANT SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN) (P000025/S063) | Med-El Corp. | 2013-06-06 |
| PRODIGY IPG (P890003/S276) | Medtronic, Inc. | 2013-06-06 |
| BI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1359-XX-S) (P950005/S041) | Biosense Webster, Inc. | 2013-06-06 |
| FREEZOR MAX CARDIAC CRYO ABLATION CATHETER (P100010/S027) | Medtronic Cryocath, LP | 2013-06-06 |
| ELLIPSE FAMILY OF ICDS (P910023/S315) | ABBOTT MEDICAL | 2013-06-06 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS (P030054/S238) | ABBOTT MEDICAL | 2013-06-06 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S014) | Boston Scientific Corp | 2013-06-06 |
| WALLSTENT ENDOPROSTHESIS TIPS (P930031/S043) | Boston Scientific Corp | 2013-06-06 |
| FREEZOR CARDIAC CRYO ABLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYO ABLATION DEVICE, FREEZOR MAX SURGICAL CARDI (P020045/S047) | Medtronic Cryocath, LP | 2013-06-06 |
| CONTAK RENEWWAL TR INVIVE FAMILIES (P030005/S098) | Guidant Corp. | 2013-06-06 |
| CONFIENT, VIVIAN, INCEPTA, ENERGEN, PUNCTUA, TELIGEN, VITALITY FAMILIES. (P960040/S294) | Boston Scientific | 2013-06-06 |
| INCEPTA ENERGEN PUNCTUA COGNIS, LIVIAN FAMILIES (P010012/S329) | Boston Scientific Corp | 2013-06-06 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S229) | ABBOTT MEDICAL | 2013-06-06 |
| WALLSTENT ENDOPROSTHESIS VENOUS (P980033/S032) | Boston Scientific Corporation | 2013-06-06 |
| WALLSTENT ENDOPROSTHESIS ILIAC (P940019/S037) | Boston Scientific Scimed, Inc. | 2013-06-06 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST,V2.0 (P050028/S032) | Roche Molecular Systems, Inc. | 2013-06-06 |
| ADAPTA,VERSA,SENSIA IPG (P980035/S324) | Medtronic, Inc. | 2013-06-06 |
| FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS (P030035/S107) | ABBOTT MEDICAL | 2013-06-06 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S012) | Boston Scientific Corp | 2013-06-06 |
| INSIGNIA, ALTRUA, INGENIO, ADVANTIO FAMILIES (N970003/S151) | Boston Scientific Corp | 2013-06-06 |
| 5846 DISPOSABLE PATIENT CABLE (P820003/S121) | Medtronic Cardiac Rhythm Disease Management | 2013-06-06 |
| MICRONY FAMILY PACEMAKERS (P970013/S054) | ABBOTT MEDICAL | 2013-06-06 |
| COBAS AMPLIPREP/COBRA TAQMAN CMV TEST (P110037/S006) | Roche Molecular Systems, Inc. | 2013-06-06 |
| ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS (P910023/S309) | ABBOTT MEDICAL | 2013-06-06 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.0 (P000012/S041) | Roche Molecular Systems, Inc. | 2013-06-06 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.0 (P060030/S032) | Roche Molecular Systems, Inc. | 2013-06-06 |
| ESTEEM SYSTEM (P090018/S020) | Envoy Medical Corporation | 2013-06-06 |
| UNI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1355-XX S) (P010068/S031) | Biosense Webster, Inc. | 2013-06-06 |
| PRIMEADVANCED SURESCAN MRI IMPLANTABLE NEUROSTIMULATOR (P840001/S240) | Medtronic Neuromodulation | 2013-06-05 |
| EUFLEXXA (P010029/S017) | Ferring Pharmaceuticals, Inc. | 2013-06-04 |
| BVI 1%OVD (P960011/S023) | Altacor , Ltd. | 2013-06-04 |
| PRECISION SPINAL CORD STIMULATOR (SCS)SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR(SCS)SYSTEM (P030017/S163) | Boston Scientific Corp | 2013-06-04 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S051) | W. L. Gore & Associates, Inc. | 2013-06-04 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM,PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S164) | Boston Scientific Corp | 2013-06-04 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S026) | ABBOTT MEDICAL | 2013-06-03 |
| GELFOAM (ABSORBABLE GELATIN) POWDER,USP (N18286/S025) | Pfizer, Inc. | 2013-06-03 |
| ALAIR BRONCHIAL THERMOPLASTY SYSTEM (P080032/S013) | Boston Scientific Corp | 2013-06-03 |
| BIOCOR/EPIC VALVE (P040021/S023) | ABBOTT MEDICAL | 2013-06-03 |
| DEEP BRAIN STIMULATION (DBS) LEAD CAP (P960009/S170) | Medtronic, Inc. | 2013-06-03 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S001) | Cook Ireland, Ltd. | 2013-06-03 |
| PROMERA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S013) | Infusyn Therapeutics, LLC | 2013-06-03 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S028) | Integra Lifesciences Corp. | 2013-06-03 |
| COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY (P840062/S026) | Integra Lifesciences Corp. | 2013-06-03 |
| COLLASTAT ABSORBABLE COLLEGEN HEMOSTATIC SPONGE (P810006/S037) | Integra LifeSciences Corporation | 2013-06-03 |
| INTACS CORNEAL IMPLANTS (P980031/S012) | Addition Technology | 2013-06-03 |
| HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S034) | Integra LifeSciences Corporation | 2013-06-03 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S027) | ABBOTT MEDICAL | 2013-06-03 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S033) | Coloplast Corp. | 2013-05-31 |
| INFUSE BONE GRAFT (P000054/S039) | Medtronic Sofamor Danek USA, Inc. | 2013-05-31 |
| CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM (P970029/S024) | Cryolife, Inc. | 2013-05-31 |
| EPIC VASCULAR SELF EXPANDING STENT SYSTEM (P110035/S013) | Boston Scientific Corp | 2013-05-31 |
| SYNERGYST II PACING SYSTEM (P890003/S265) | Medtronic, Inc. | 2013-05-30 |
| REGENT MECHANICAL HEART VALVE, STANDARD MECHANICAL HEART VALVE, MASTER MECHANICAL HEART VALVE (P810002/S085) | ABBOTT MEDICAL | 2013-05-30 |
| RADIESSSE (P050052/S040) | Merz North America, Inc. | 2013-05-30 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S019) | Syncardia Systems, LLC | 2013-05-30 |
| IDENTITY, VERITY, INTEGRITY, VOCTORY, XEPHYR, ACCENT FAMILY OF PACEMAKER DEVICES (P880086/S233) | ABBOTT MEDICAL | 2013-05-30 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S157) | Boston Scientific Corp | 2013-05-30 |
| RADIESSE (P050037/S037) | Merz North America, Inc. | 2013-05-30 |
| FRONTIER, FRONTIER II, ANTHEM FAMILY OF CRT-P DEVICES (P030035/S111) | ABBOTT MEDICAL | 2013-05-30 |
| VERSATRAX PACING SYSTEM (P820003/S117) | Medtronic Cardiac Rhythm Disease Management | 2013-05-30 |
| ATTAIN STARFIX LEAD (P060039/S046) | Medtronic, Inc. | 2013-05-29 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S076) | Medtronic, Inc. | 2013-05-29 |
| TENDRILL STS MODEL 2088TC LEAD (P960013/S075) | ABBOTT MEDICAL | 2013-05-29 |
| 3F AORTIC BIOPROSTHESIS (P060025/S010) | Medtronic, Inc. | 2013-05-29 |
| CAPSURE LEAD (P890003/S275) | Medtronic, Inc. | 2013-05-29 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S032) | Bard Peripheral Vascular | 2013-05-29 |
| INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL (P100027/S010) | Ventana Medical Systems, Inc. | 2013-05-29 |
| KAINOX VCS,LINOX,LINOX SMART,VIGILA,VOLTA (P980023/S055) | Biotronik, Inc. | 2013-05-29 |
| DEXTRUS,ECURO,EFFECTA,ESTELLA,EVIA,ENTOVIS,SELOX,SETROX S,SOLOX,TILDA (P950037/S123) | Biotronik, Inc. | 2013-05-29 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S069) | Med-El Corp. | 2013-05-29 |
| DBS LEADS(DEEP BRAIN STIMULATION) (P960009/S171) | Medtronic, Inc. | 2013-05-29 |