| ESTEEM (P090018/S008) | Envoy Medical Corporation | 2010-11-23 |
| ATTAIN STARFIX LEAD DRUG COMBINATION (P060039/S019) | Medtronic, Inc. | 2010-11-23 |
| ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ACCESSORY (UPSIZING SLEEVE) (P900061/S096) | Medtronic Cardiac Rhythm Disease Management | 2010-11-23 |
| ECG CABLE/CAPSURE VDD LEADS DRUG COMBINATION/SERVICE KIT PACEMAKER REPAIR KIT/PRODIGY IPG/BRILLIANT S+ VDD VITATRON LEAD (P890003/S206) | Medtronic, Inc. | 2010-11-23 |
| ATTAIN LEAD DRUG COMBINATION 4193 & 4194/INSYNC CRT-P/INSYNC III CRT-P (P010015/S103) | Medtronic, Inc. | 2010-11-23 |
| SPRINT LEAD/TRANSVENE DF1/RV LEAD/SPRINT QUATTRO/TRANSVENE SVC/CS/SUBCUTANEOUS/TUNNELING TOOL/TRANSVENE SUBQ LEADS (P920015/S070) | Medtronic, Inc. | 2010-11-23 |
| SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVOCES (OVD), HEALON GV, HEALON5 PRODUCTS (P810031/S038) | Johnson & Johnson Surgical Vision, Inc. | 2010-11-22 |
| HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT MODEL 150 (P790007/S028) | Medtronic Heart Valves | 2010-11-19 |
| MODEL 8005 CIRCUCOOL PUMP (P980003/S026) | Boston Scientific Corp | 2010-11-19 |
| CONTAK & RENEWAL FAMILIES (P010012/S258) | Boston Scientific Corp | 2010-11-19 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS MODELS 995/995CS/995MS (P970031/S030) | Medtronic, Inc. | 2010-11-19 |
| IMPLANTABLE PULSE GENERATOR (P890003/S205) | Medtronic, Inc. | 2010-11-19 |
| HANCOCK PORCINE BIOPROSTHESIS, LOW POROSITY VALVED CONDUIT MODEL 105 (P870078/S012) | Medtronic, Inc. | 2010-11-19 |
| VERIFLEX MONORAIN & OVER-THE-WIRE CORONARY STENT SYSTEM (P040016/S064) | Boston Scientific Scimed, Inc. | 2010-11-19 |
| LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR MODEL 6481 SOFTWARE, VERSION 1.6. (P910077/S109) | Boston Scientific | 2010-11-19 |
| IMPLANTABLE PULSE GENERATOR SYSTEM (P010032/S034) | ABBOTT MEDICAL | 2010-11-19 |
| AORTIC ROOT BIOPROSTHESIS MODELS 995, 995CS, 995MS (P970031/S031) | Medtronic, Inc. | 2010-11-19 |
| HANCOCK II PORCINE BIOPROSTHESIS MODELS T505/T510 (P980043/S028) | Medtronic, Inc. | 2010-11-19 |
| HANCOCK PORCINE BIOPROSTHESIS MODEL 105 (P870078/S013) | Medtronic, Inc. | 2010-11-19 |
| PRIZM AND VITALITY FAMILY (P960040/S238) | Boston Scientific | 2010-11-19 |
| HANCOCK I MODIFIED ORIFICE VALVED CONDUIT MODEL 150 (P790007/S027) | Medtronic Heart Valves | 2010-11-19 |
| PORCINE BIOPROSTHESIS MODELS 305, 310 (P990064/S036) | Medtronic, Inc. | 2010-11-19 |
| HANCOCK II PORCINE BIOPROSTHESIS MODELS T505, T510 (P980043/S029) | Medtronic, Inc. | 2010-11-19 |
| PRODISC C TOTAL DISC REPLACEMENT (P070001/S005) | Centinel Spine, LLC | 2010-11-19 |
| MOSAIC PORCINE BIOPROSTHESIS MODELS 305/310 (P990064/S035) | Medtronic, Inc. | 2010-11-19 |
| EXPRESS MONORAIL & OVER-THE-WIRE CORONARY STENT SYSTEM (P020009/S067) | Boston Scientific Scimed, Inc. | 2010-11-19 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S026) | Abbott Laboratories | 2010-11-18 |
| SAFIRE CARDIAC ABLATION SYSTEM (P960016/S034) | St Jude Medical | 2010-11-18 |
| VISTAKON (SENOFILCON A) CONTACT LENSES, CLEAR & VISIBILITY TINTED WITH UV BLOCKER (P040045/S014) | Vistakon, Division of Johnson & Johnson Vision Car | 2010-11-18 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S030) | Abbott Laboratories | 2010-11-18 |
| VNS THERAPY SYSTEM (P970003/S115) | LivaNova USA, Inc. | 2010-11-18 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S110) | Boston Scientific Corp | 2010-11-17 |
| PADDLE LEAD KITS DFU (P010032/S035) | ABBOTT MEDICAL | 2010-11-17 |
| CONTINUOUS GLUCOSE MONITORING SYSTEM, SOF-SENSOR MMT-7002 (P980022/S076) | Medtronic Minimed | 2010-11-17 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S048) | Medtronic, Ireland | 2010-11-17 |
| PATHWAY ANTI-HER 2INEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S008) | Ventana Medical Systems, Inc. | 2010-11-17 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S013) | Ortho-Clinical Diagnostics | 2010-11-16 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S061) | Boston Scientific Corp | 2010-11-16 |
| VITROS IMMUNDIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S020) | Ortho-Clinical Diagnostics, Inc. | 2010-11-16 |
| VITROS IMMUNODIAGNOSTICS HBSAG REAGENT PACK & CALIBRATOR (P000044/S025) | Ortho-Clinical Diagnostics, Inc. | 2010-11-16 |
| HOLOGIC SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S019) | Hologic, Inc. | 2010-11-16 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR (P000014/S022) | Ortho-Clinical Diagnostics, Inc. | 2010-11-16 |
| DEXCON SEVEN AND SEVEN PLUS (P050012/S027) | Dexcom, Inc. | 2010-11-16 |
| IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT/QUATTRO/SUBCUTANEOUS LEAD/SUB-Q TUNNELING TOOL/TRANSVENE CS/SVC/DF1/RV/SUBQ/SVC (P920015/S061) | Medtronic, Inc. | 2010-11-10 |
| DISPOSABLE COVER (P820003/S095) | Medtronic Cardiac Rhythm Disease Management | 2010-11-10 |
| CLARITY/DA+C & T SERIES/DIAMOND 3/II/JADE 3/II/RUBY 3/II/ SELECTION AFM/TOPAZ 3/II/VITA/VITA 2 (P990001/S072) | Medtronic, Inc. | 2010-11-10 |
| INTERSTIM IMPLANTABLE NEUROSTIMULATOR (P970004/S096) | Medtronic Neuromodulation | 2010-11-10 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S021) | Medtronic, Inc. | 2010-11-10 |
| TELIGEN 4-SITE MODELS (P960040/S198) | Boston Scientific | 2010-11-10 |
| LEAD TUNNELER MODEL 6888 (P830060/S062) | Boston Scientific | 2010-11-10 |
| CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D CONCERTO (P010031/S217) | Medtronic Cardiac Rhythm Disease Management | 2010-11-10 |
| TOROSA TESTICULAR PROSTHESIS (P020003/S007) | Coloplast Corp. | 2010-11-10 |
| INSYNC CRT-P (P010015/S101) | Medtronic, Inc. | 2010-11-10 |
| JEWEL AF/GEM III AT/CS-SVC TRANSVENE LEAD (P980050/S050) | Medtronic, Inc. | 2010-11-10 |
| ADAPTA/VERSA/SENSIA/RELIA/ENRHYTHM IPGS (P980035/S189) | Medtronic, Inc. | 2010-11-10 |
| ATTAIN LEADS (P010015/S102) | Medtronic, Inc. | 2010-11-10 |
| ATTAIN/INSYNC & INSYNC III (P010015/S093) | Medtronic, Inc. | 2010-11-10 |
| CAPSURE/CAPSUREFIX NOVUS/CAPSUREFIX/SUREFIX/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET S+ (P930039/S039) | Medtronic, Inc. | 2010-11-10 |
| ACCESSORY (UPSIZING SLEEVE)/UNIPOLAR/GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN CAP/MICRO JEWEL/II/TRANSVENE DEFIBR (P900061/S091) | Medtronic Cardiac Rhythm Disease Management | 2010-11-10 |
| CAPSURE/BRILLIANT S+VDD LEADS/PRODIGY/SERVICE KIT-PACEMAKER REPAIR KIT/THERA-I/VITATRON LEGACY/LEGACY II/VISA (P890003/S194) | Medtronic, Inc. | 2010-11-10 |
| CONCERTO/II/CONSULTA/INSYNC ICD/INSYNC MARQUIS/MAXIMO/INSYNC II MARQUIS/MAXIMO II/INSYNC II PROTECT/III MARQUIS/SENTRY (P010031/S206) | Medtronic Cardiac Rhythm Disease Management | 2010-11-10 |
| ACTIVA RC & SOLETRA IMPLANTABLE NEUROSTIMULATORS (P960009/S099) | Medtronic, Inc. | 2010-11-10 |
| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM (P960042/S022) | Spectranetics (Philips) | 2010-11-10 |
| ITREL 3 & RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S167) | Medtronic Neuromodulation | 2010-11-10 |
| CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D CONCERTO (P010031/S218) | Medtronic Cardiac Rhythm Disease Management | 2010-11-10 |
| CAPSURE/ENTRUST/GEM/II/III/INTRINSIC/MARQUIS/MAXIMO/II/ONYX/SECURA/VIRTUOSO/II (P980016/S250) | Medtronic Cardiac Rhythm Disease Management | 2010-11-10 |
| CAPSURE/CAPSURE SENSE/CAPSURE SP NOVUS/VITATRON CRYSTALINE/VITATRON EXCELLENCE PS+/VITATRON EXCELLENCE + (P830061/S052) | Medtronic Cardiac Rhythm Disease Management | 2010-11-10 |
| TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S014) | Cerenovus, Inc. | 2010-11-10 |
| DEMA IPGS/ C & T SERIES IPGS (P990001/S077) | Medtronic, Inc. | 2010-11-10 |
| SELECTSECURE/ANCHORING SLEEVE KIT (P030036/S018) | Medtronic Cardiac Rhythm Disease Management | 2010-11-10 |
| COGNIS 4-SITE MODELS (P010012/S212) | Boston Scientific Corp | 2010-11-10 |
| ENDOTAK RELIANCE 4-SITE LEADS AND ACCESSORIES (P910073/S077) | Boston Scientific | 2010-11-10 |
| ATTAIN STARFIX (P060039/S013) | Medtronic, Inc. | 2010-11-10 |
| KAPPA 400 DR/SR IPG (P970012/S075) | Medtronic, Inc. | 2010-11-10 |
| 350 SERIES/ADAPTA/AT500/ENPULSE/ENRHYTHM/KAPPA 600/700/800/900/RELIA/SENSIA/VERSA/SIGMA (P980035/S177) | Medtronic, Inc. | 2010-11-10 |
| ATTAIN ABILITY LV LEAD (P080006/S016) | Medtronic, Inc. | 2010-11-10 |
| RF MARINR/NTC/5F RF MARINR/RF CONDUCTR/RF ENHANCR II/RF CONTACTR (P930029/S023) | Medtronic, Inc. | 2010-11-10 |
| SPRINT QUATTRO LEADS MODELS 6935/6947 (P920015/S069) | Medtronic, Inc. | 2010-11-10 |
| KAPPA 400 (P970012/S071) | Medtronic, Inc. | 2010-11-10 |
| ATTAIN STARFIX LEAD (P060039/S018) | Medtronic, Inc. | 2010-11-10 |
| DISCOVISC, VISCOAT AND DUOVISC (P840064/S045) | Alcon Laboratories | 2010-11-10 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S017) | Vistakon, Division of Johnson & Johnson Vision Car | 2010-11-10 |
| SPRINT QUATTRO SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD (P920015/S068) | Medtronic, Inc. | 2010-11-10 |
| CELLUGEL (P990023/S010) | Alcon Laboratories | 2010-11-10 |
| SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/VIRTUOSO ICD (P980016/S261) | Medtronic Cardiac Rhythm Disease Management | 2010-11-10 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S050) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2010-11-10 |
| ADAPTA/VERSA/SENSIA/RELIA/ENRHYTHM IPGS (P980035/S190) | Medtronic, Inc. | 2010-11-10 |
| ATTAIN (P080006/S010) | Medtronic, Inc. | 2010-11-10 |
| PRODIGY SR (P890003/S204) | Medtronic, Inc. | 2010-11-10 |
| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM (P910001/S038) | Spectranetics Corp. | 2010-11-10 |
| CAPSURE/Z NOVUS/SP NOVUS/FIX/STERX TIP PACING LEAD (VENTRICULAR)/VITATRON EXCELLENCE S+/SS+/IMPULSE/IMPULSE II (P850089/S066) | Medtronic Cardiac Rhythm Disease Management | 2010-11-10 |
| PROVISC (P890047/S033) | Alcon Research, Ltd. | 2010-11-10 |
| SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/VIRTUOSO ICD (P980016/S262) | Medtronic Cardiac Rhythm Disease Management | 2010-11-10 |
| CONTINUOUS GLUCOSE MONITORING SYSTEM SOF-SENSOR GLUCOSE SENSOR MMT-7003 (P980022/S088) | Medtronic Minimed | 2010-11-09 |
| XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S050) | Abbott Vascular, Inc. | 2010-11-08 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S194) | ABBOTT MEDICAL | 2010-11-08 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S069) | St. Jude Medical, Inc. | 2010-11-08 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S037) | ABBOTT MEDICAL | 2010-11-08 |
| TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S005) | Biomet Microfixation, Inc. | 2010-11-08 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S074) | ABBOTT MEDICAL | 2010-11-08 |