| ECG CABLE/CAPSURE VDD LEADS DRUG COMBINATION/SERVICE KIT PACEMAKER REPAIR KIT/PRODIGY IPG/BRILLIANT S+ VDD VITATRON LEAD (P890003/S207) | Medtronic, Inc. | 2010-12-08 |
| ATTAIN ABILITY LEAD DRUG COMBINATION (P080006/S018) | Medtronic, Inc. | 2010-12-08 |
| DISPOSABLE EPG COVER (P820003/S102) | Medtronic Cardiac Rhythm Disease Management | 2010-12-08 |
| CAPSURE FIX/NOVUS LEAD DRUG COMBINATION/SURE FIX/VITATRON PIROUET+/VITATRON CRYSTALINE LEAD DRUG COMBINATION (P930039/S047) | Medtronic, Inc. | 2010-12-08 |
| TRANSVENE CS/SVC LEAD (P980050/S056) | Medtronic, Inc. | 2010-12-08 |
| ADAPTA/SENSIA/VERSA/AT500/350 SERIES/ENRHYTHM/ENPULSE/KAPPA 700/800/900/RELIA/SIGMA IPGS (P980035/S194) | Medtronic, Inc. | 2010-12-08 |
| CAPSURE EPICARDIAL PACING LEAD DRUG COMBINATION (P950024/S027) | Medtronic, Inc. | 2010-12-08 |
| CLARITY /VITATRON DA+ C-SERIES/DIAMOND 3/JADE 3/RUBY 3/VITATRON DA+ T-SERIES/TOPAZ 3/VITA 2/VITA IPGS (P990001/S079) | Medtronic, Inc. | 2010-12-08 |
| MEDTRONICS ADAPTA, VERSA, SENSIA AND RELIA IMPLANTABLE PULSE GENERATOR (P980035/S150) | Medtronic, Inc. | 2010-12-08 |
| CAPSURE LEAD DRUG COMBINATION/MARQUIS/MAXIMO/INTRINSIC30/INTRINSIC/ENTRUST/VIRTUOSO/SECURA/VIRTUOSO II/MAXIMO II ICDS (P980016/S265) | Medtronic Cardiac Rhythm Disease Management | 2010-12-08 |
| PHILOS DR/DR-B/SR/SR-B/DR-T/PHILOS II DR/DR-T/SR/CYLOS DR/DR-T/VR/EVIA DR/DR-T/SR/SR-T/ENTOVIS DR/DR-T/SR/SR-T (P950037/S090) | Biotronik, Inc. | 2010-12-08 |
| KAPPA 400 IPG (P970012/S078) | Medtronic, Inc. | 2010-12-08 |
| CAPSURE /STERX TIP PACING LEAD (VENTRICULAR/CAPSURE Z/SP NOVUS/VITATRON IMPULSE/II/EXCELLENCE S+/SS+ LEAD DRUG (P850089/S072) | Medtronic Cardiac Rhythm Disease Management | 2010-12-08 |
| VITATRON CRYSTALINE/EXCELLENCE +/PS+/CAPSURE SP/CAPSURE SENSE/CAPSURE SP NOVUS/CAPSURE LEAD DRUG COMBINATION (P830061/S059) | Medtronic Cardiac Rhythm Disease Management | 2010-12-08 |
| ATTAIN STARFIX LEAD DRUG COMBINATION (P060039/S020) | Medtronic, Inc. | 2010-12-08 |
| STRATOS LV/LV-T (P070008/S020) | Biotronik, Inc. | 2010-12-08 |
| ATTAIN LEAD DRUG COMBINATION: 4193 & 4194 ONLY/INSYNC CRT-P/INSYNC III CRT-P (P010015/S104) | Medtronic, Inc. | 2010-12-08 |
| SELECTSECURE LEAD DRUG COMBINATION/ANCHORING SLEEVE KIT (P030036/S025) | Medtronic Cardiac Rhythm Disease Management | 2010-12-08 |
| LEAD ADAPTOR/IS-1 CONNECTOR PORT PIN PLUG KIT/Y ADAPTOR/EXTENDER KIT/SPRINT LEAD DRUG COMBINATION/TRANSVENE DF1/RV LEAD (P920015/S071) | Medtronic, Inc. | 2010-12-08 |
| TALENT CONVERTER STENT GRAFT SYSTEM AND TALENT OCCLUDER SYSTEM (P070027/S024) | Medtronic Vascular | 2010-12-08 |
| INSYNC II/III MARQUIS/INSYNC SENTRY/MAXIMO/II/CONCERTO/II/CONSULTA (P010031/S220) | Medtronic Cardiac Rhythm Disease Management | 2010-12-08 |
| ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR (P900061/S097) | Medtronic Cardiac Rhythm Disease Management | 2010-12-08 |
| RF /RF MARINR NTC/5F RF MARINR/RF CONDUCTR/RF ENHANCR II ABLATION/RF CONTACTR CATHETERS (P930029/S028) | Medtronic, Inc. | 2010-12-08 |
| REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S015) | Smith & Nephew, Inc. | 2010-12-07 |
| VISION RX/OTW/MINI VISION RX/OTW/MULTI LINK 8 RX (P020047/S027) | Abbott Vascular | 2010-12-07 |
| 350 SERIES/ADAPTA/ENPULSE/KAPPA 600/650/700/800/900/SIGMA (P980035/S192) | Medtronic, Inc. | 2010-12-07 |
| INFUSE BONE GRAFT (P050053/S016) | Medtronic, Inc. | 2010-12-07 |
| LIVEWIRE CARDIAC ABLATION SYSTEM (P960016/S035) | St Jude Medical | 2010-12-07 |
| ZETA RX/ULTRA RX/ULTRA OTW (P970020/S059) | Abbott Vascular, Inc. | 2010-12-07 |
| INFUSE BONE GRAFT (P000054/S025) | Medtronic Sofamor Danek USA, Inc. | 2010-12-07 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S038) | Medtronic Sofamor Danek USA, Inc. | 2010-12-07 |
| ST JUDE MEDICAL MERLIN 3650 PROGRAMMER (P030054/S174) | ABBOTT MEDICAL | 2010-12-07 |
| KAPPA 400 (P970012/S077) | Medtronic, Inc. | 2010-12-07 |
| MARQUIS/MAXIMO (P980016/S264) | Medtronic Cardiac Rhythm Disease Management | 2010-12-07 |
| SECONDLOOK (SL) CAD (P010038/S013) | Icad, Inc. | 2010-12-07 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V.2.0 (P050028/S012) | Roche Molecular Systems, Inc. | 2010-12-07 |
| MEDTRONIC MODEL 5388 EXTERNAL PULSE GENERATOR (P820003/S100) | Medtronic Cardiac Rhythm Disease Management | 2010-12-07 |
| XIENCE V RX/PROMUS RX/XIENCE OTW/PROMUS OTW (P070015/S053) | Abbott Vascular, Inc. | 2010-12-07 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S036) | St Jude Medical | 2010-12-07 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S057) | W. L. Gore & Associates, Inc. | 2010-12-07 |
| DURATA SJ4/DF4 FAMILIES OF HIGH VOLTAGE LEADS (P950022/S075) | ABBOTT MEDICAL | 2010-12-06 |
| HANCOCK APICAL LEFT VENTRICLE CONNECTOR (P870078/S011) | Medtronic, Inc. | 2010-12-03 |
| THERAPY COOL PATH ABLATION CATHETER (P060019/S013) | Irvine Biomedical, Inc. | 2010-12-03 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S006) | Boston Scientific Corp | 2010-12-03 |
| ORATAPE ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY (P840062/S021) | Integra Lifesciences Corp. | 2010-12-03 |
| LUMAX FAMILY OF ICDS AND CRT-DS (P050023/S038) | Biotronik, Inc. | 2010-12-03 |
| SYNCHROMED2 PUMP FEED-THROUGHS & CATHETER ACCESSORIES (P860004/S128) | Medtronic, Inc. | 2010-12-03 |
| SEPRAFILM (P950034/S036) | Baxter Healthcare Corporation | 2010-12-02 |
| HYDRELLE (P050033/S011) | Anika Therapeutics, Inc. | 2010-12-02 |
| VITAGEL SURGICAL HEMOSTAT (P050044/S015) | Stryker Corp. | 2010-12-02 |
| AMS UROLUME ENDOPROSTHESIS (P920023/S029) | Boston Scientific Corp | 2010-12-02 |
| DRIVER & MICRO-DRIVER CORONARY STENT SYSTEM (P030009/S049) | Medtronic, Ireland | 2010-12-01 |
| STAARVISC II & SHELLGEL SODIUM HYALURONATE (P000046/S018) | Anika Therapeutics, Inc. | 2010-12-01 |
| KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE (P080018/S001) | Carestream Health, Inc. | 2010-12-01 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S052) | Abbott Vascular, Inc. | 2010-12-01 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S053) | Boston Scientific Corp | 2010-12-01 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S059) | Medtronic, Inc. | 2010-12-01 |
| AMVISC/AMVISC PLUS (OPHTHALMIC VISCOSURGICAL DEVICES) (P810025/S030) | Bausch & Lomb, Inc. | 2010-12-01 |
| TECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION (P990027/S015) | Technolas Perfect Vision GmbH | 2010-11-30 |
| STRATOS LV/LV-T CRT-P (P070008/S017) | Biotronik, Inc. | 2010-11-26 |
| OPTISENSE MODEL 1999 LEAD (P960013/S057) | ABBOTT MEDICAL | 2010-11-26 |
| EVIA/ENTOVIS DR/DR-T/SR-T & VARIOUS OTHER MODELS OF PULSE GENERATORS (P950037/S083) | Biotronik, Inc. | 2010-11-26 |
| BELOS/LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T, & XELOS DR-T ICDS (P000009/S040) | Biotronik, Inc. | 2010-11-26 |
| VARIOUS MODELS OF LUMAX ICD/CRT-D FAMILIES (P050023/S033) | Biotronik, Inc. | 2010-11-26 |
| GORE VIABAHN ENDOPROSTHESIS (WITH HEPARIN BIOACTIVE SURFACE) (P040037/S032) | W. L. Gore & Associates, Inc. | 2010-11-24 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S063) | Cochlear Americas | 2010-11-24 |
| SOLETRA/KINETRA/EXTERNAL/ACTIVA FAMILY OF NEUROSTIMULATORS (P960009/S100) | Medtronic, Inc. | 2010-11-24 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S031) | W. L. Gore & Associates, Inc. | 2010-11-24 |
| INTERSTIM/INTERSTIM II NEUROSTIMULATOR (P970004/S097) | Medtronic Neuromodulation | 2010-11-24 |
| SYNVISC (HYLAN G-F 20) AND SYNVISC-ONE (HYLAN G-F 20) (P940015/S018) | Sanofi Genzyme Corp. | 2010-11-24 |
| SYNCHROMED II INFUSION PUMP (P860004/S143) | Medtronic, Inc. | 2010-11-24 |
| ITREL 3 IMPLANTABLE/SYNERGY FAMILY OF IMPLANTABLE NEUROSTIMULATORS/EXTERNAL NEUROSTIMULATORS (P840001/S168) | Medtronic Neuromodulation | 2010-11-24 |
| DISPOSABLE EPG COVER (P820003/S101) | Medtronic Cardiac Rhythm Disease Management | 2010-11-23 |
| GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S031) | Gynecare, Inc. | 2010-11-23 |
| VISTAKON (ETAFILCON A) CONTACT LENSES/CLEAR/VISIBILITY TINTED WITH UV BLOCKER (N18033/S049) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2010-11-23 |
| CAPSURE/STERX TIP PACING/CAPSURE Z/SP NOVUS/VITATRON IMPULSE/II/VITATRON EXCELLENCE S+/VITATRON EXCELLENCE SS+ LEAD DRUG (P850089/S071) | Medtronic Cardiac Rhythm Disease Management | 2010-11-23 |
| CAPSURE LEAD DRUG COMBINATION/MARQUIS/MAXIMO/INTRINSIC3/INTRINSIC/ENTRUST/VIRTUOSO/SECURA/VIRTUOSO II/MAXIMO II ICDS (P980016/S263) | Medtronic Cardiac Rhythm Disease Management | 2010-11-23 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S028) | Abbott Laboratories | 2010-11-23 |
| MONOLISA ANTI-HBC IGM EIA (P060034/S005) | Bio-Rad Laboratories, Inc. | 2010-11-23 |
| VITATRON CRYSTALINE/VITATRON EXCELLENCE +/VITATRON EXCELLENCE PS+/CAPSURE SP/CAPSURE SENSE/CAPSURE SP NOVUS/CAPSURE LEAD (P830061/S058) | Medtronic Cardiac Rhythm Disease Management | 2010-11-23 |
| ATTAIN ABILITY LEAD DRUG COMBINATION (P080006/S017) | Medtronic, Inc. | 2010-11-23 |
| INSYNC III/II MARQUIS CRT-D/INSYNC SENTRY/MAXIMO CRT-D/CONCERTO/CONSULTA/CONCERTO II/MAXIMO II CRT-D (P010031/S219) | Medtronic Cardiac Rhythm Disease Management | 2010-11-23 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S011) | Natus Medical Incorporated | 2010-11-23 |
| ACRYSOF IQ TORIC INTRAOCULAR LENSES (P930014/S046) | Alcon Laboratories, Inc. | 2010-11-23 |
| VNS THERAPY SYSTEM MODEL 250 PROGRAMMING SOFTWARE, VERSION 8.0 (P970003/S116) | LivaNova USA, Inc. | 2010-11-23 |
| ADAPTA/SENSIA/VERSA/AT500/350 SERIES/ENRHYTHM/ENPULSE/KAPPA 700/800/900/RELIA/SIGMA IPGS (P980035/S191) | Medtronic, Inc. | 2010-11-23 |
| CAPSURE FIX/NOVUS/SUREFIX/VITATRON PIROUET+/VITATRON CRYSTALINE LEAD DRUG COMBINATIONS (P930039/S046) | Medtronic, Inc. | 2010-11-23 |
| CLARITY/VITATRON DA+C-SERIES/DIAMOND 3/JADE 3/RUBY 3/VITATRON DA+T-SERIES/TOPAZ 3/VITA 2/VITA IPGS (P990001/S078) | Medtronic, Inc. | 2010-11-23 |
| MONOLISA ANTI-HBC EIA (P060031/S004) | Bio-Rad Laboratories, Inc. | 2010-11-23 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S029) | Abbott Laboratories | 2010-11-23 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S031) | Abbott Laboratories | 2010-11-23 |
| CAPSURE EPICARDIAL PACING LEAD DRUG COMBINATION (P950024/S026) | Medtronic, Inc. | 2010-11-23 |
| ARTISAN MYOPIA PHAKIC IOL (P030028/S002) | Ophtec BV | 2010-11-23 |
| RF MARINR/NTC/5F RF MARINR/RF CONDUCTR/RF ENHANCR II ABLATION/RF CONTACTR/CONDUCTR SELF-REF/ATAKR II (P930029/S027) | Medtronic, Inc. | 2010-11-23 |
| SELECTSECURE LEAD DRUG COMBINATION/ANCHORING SLEEVE KIT (P030036/S024) | Medtronic Cardiac Rhythm Disease Management | 2010-11-23 |
| MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT (P050048/S005) | Bio-Rad Laboratories | 2010-11-23 |
| ACRYSOF IQ RESTOR INTRAOCULAR LENSES (P040020/S028) | Alcon Research, Ltd. | 2010-11-23 |
| TRANSVENE CS/SVC LEAD (P980050/S055) | Medtronic, Inc. | 2010-11-23 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S027) | Abbott Laboratories | 2010-11-23 |
| KAPPA 400 IPG (P970012/S076) | Medtronic, Inc. | 2010-11-23 |