| FILL/FLUSH EXTRACTION SYSTEM FOR ACRYSOF, AND ACRYSOF RESTOR INTRAOCULAR LENSES (P930014/S052) | Alcon Laboratories, Inc. | 2011-07-21 |
| CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT (P890003/S231) | Medtronic, Inc. | 2011-07-21 |
| KAPPA 400 IPG (P970012/S087) | Medtronic, Inc. | 2011-07-21 |
| SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD) (P810031/S039) | Johnson & Johnson Surgical Vision, Inc. | 2011-07-21 |
| ARCHITECT AUSAB (P050051/S006) | Abbott Laboratories, Inc. | 2011-07-20 |
| URO VYSION BLADDER CANCER KIT ASSAY (P030052/S008) | Abbott Molecular | 2011-07-20 |
| ARCHITECT CORE (P080023/S003) | Abbott Laboratories | 2011-07-20 |
| THERAPY PULSE GENERATORS (P970003/S129) | LivaNova USA, Inc. | 2011-07-20 |
| RX HERCULINK ELITE RENAL STENT SYSTEM (P110001) | Abbott Vascular | 2011-07-20 |
| ARCHITECT ANTI-HCV (P050042/S007) | Abbott Laboratories, Inc. | 2011-07-20 |
| ARCHITECT CORE-M (P060035/S003) | Abbott Laboratories | 2011-07-20 |
| CORONARY FLEXTOME CUTTING BALLOON (P950020/S045) | Boston Scientific Corp | 2011-07-20 |
| ARCHITECT HBSAG/CONFIRMATORY (P060007/S005) | Abbott Laboratories | 2011-07-20 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS (P100001) | Ortho-Clinical Diagnostics | 2011-07-20 |
| ON-X PROSTHETIC HEART VALVE (P000037/S023) | On-X Life Technologies, Inc. | 2011-07-20 |
| BLAZER II/PRIME HTD CATHETER (P920047/S047) | Boston Scientific Corp | 2011-07-19 |
| WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S024) | Boston Scientific Scimed, Inc. | 2011-07-19 |
| ANJIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S036) | Boston Scientific Corp | 2011-07-19 |
| WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S029) | Boston Scientific Corp | 2011-07-19 |
| CHILLI II CATHETER (P980003/S029) | Boston Scientific Corp | 2011-07-19 |
| WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S018) | Boston Scientific Corporation | 2011-07-19 |
| BLAZER II XP/PRIME XP CATHETER (P020025/S028) | Boston Scientific | 2011-07-19 |
| HYLAFORM (HYLAN B GEL); PREVELLE SILK (P030032/S012) | Genzyme Biosurgery | 2011-07-18 |
| ST JUDE MEDICAL MASTERS VALVED GRAFT (P810002/S074) | ABBOTT MEDICAL | 2011-07-18 |
| RESTYLANE INJECTABLE GEL (P040024/S052) | Q-Med AB | 2011-07-18 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHETER (P100010/S008) | Medtronic Cryocath, LP | 2011-07-15 |
| MAXIMO II/SECURA/VIRTUOSO II (P980016/S306) | Medtronic Cardiac Rhythm Disease Management | 2011-07-15 |
| CARDIAC ABLATION PERCUTANEOUS CATHETER (P020045/S037) | Medtronic Cryocath, LP | 2011-07-15 |
| BD PREPSTAIN SYSTEM VACUUM PUMP SAFETY HAZARD (P970018/S023) | Bd Diagnostic Systems | 2011-07-15 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S027) | Zoll Manufacturing Corporation | 2011-07-15 |
| MAXUM SYSTEM (P010023/S009) | Ototronix, LLC | 2011-07-15 |
| REALIZE ADJUSTABLE GASTRIC BAND (P070009/S011) | Obtech Medical GmbH | 2011-07-15 |
| CONCERTO II/CONSULTA/MAXIMO II (P010031/S260) | Medtronic Cardiac Rhythm Disease Management | 2011-07-15 |
| SPECTRANETICS LASER CATHETERS SLS II LASER SHEATH (P960042/S027) | Spectranetics (Philips) | 2011-07-14 |
| SPECTRANETICS LASER CATHETERS ELCA (P910001/S045) | Spectranetics Corp. | 2011-07-14 |
| TALENT THORACIC STENT GRAFT WITH THE CAPTIVIA AND WITH THE XCELERANT DELIVERY SYSTEM (P070007/S031) | Medtronic Vascular | 2011-07-13 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S045) | Corcym S.r.l. | 2011-07-13 |
| MAXIMO II/SECURA/VIRTUOSO II (P980016/S307) | Medtronic Cardiac Rhythm Disease Management | 2011-07-13 |
| MODEL 4296 ATTAIN ABILITY PLUS LV LEAD AND MODEL 4396 ATTAIN ABILITY STRAIGHT LV LEAD (P080006/S031) | Medtronic, Inc. | 2011-07-13 |
| TALENT ABDOMINAL STENT GRAFT WITH THE XCELERANT SYSTEM (P070027/S030) | Medtronic Vascular | 2011-07-13 |
| ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT HYDRO DELIVERY SYSTEM (P990020/S046) | Medtronic Vascular | 2011-07-13 |
| CONCERTO II/CONSULTA/MAXIMO II (P010031/S261) | Medtronic Cardiac Rhythm Disease Management | 2011-07-13 |
| VALIANT THORACIC STENT GRAFT WITH THE CATIVIA DELIVERY SYSTEM (P100040/S006) | Medtronic Vascular | 2011-07-13 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S006) | Boston Scientific Corp | 2011-07-13 |
| SPOT-LIGHT HER2 CISH KIT (P050040/S001) | Invitrogen Corporation | 2011-07-12 |
| VNS THERAPY SYSTEM PULSE GENERATORS (P970003/S128) | LivaNova USA, Inc. | 2011-07-11 |
| FEMORAL INTRODUCER SHEATH & HEMOSTASIS (FISH) DEVICE (P050043/S005) | Morris Innovative Research, Inc. | 2011-07-11 |
| GELFOAM (ABSORBABLE GELATIN) STERILE SPONGE (N18286/S021) | Pfizer, Inc. | 2011-07-09 |
| RADIESSE INJECTABLE IMPLANT (P050052/S033) | Merz North America, Inc. | 2011-07-08 |
| COAPTITE INJECTABLE IMPLANT (P040047/S020) | Merz North America, Inc. | 2011-07-08 |
| RADIESSE INJECTABLE IMPLANT (P050037/S030) | Merz North America, Inc. | 2011-07-08 |
| ACRYSOF INTRAOCULAR LENSES (P930014/S049) | Alcon Laboratories, Inc. | 2011-07-08 |
| BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS (P980006/S020) | Bausch & Lomb, Inc. | 2011-07-08 |
| ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S031) | Alcon Research, Ltd. | 2011-07-08 |
| BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR (P990019/S007) | Sun Pharmaceutical Industries, Inc. | 2011-07-07 |
| CAPSURE/SP/Z NOVUS LEADS/VITATRON EXCELLENCE S+/SS+/IMPULSE/IMPULSE II LEADS (P850089/S079) | Medtronic Cardiac Rhythm Disease Management | 2011-07-07 |
| ATTAIN STARFIX LEAD (P060039/S027) | Medtronic, Inc. | 2011-07-07 |
| DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1 (P900061/S104) | Medtronic Cardiac Rhythm Disease Management | 2011-07-07 |
| ATTAIN ABILITY/PLUS LEAD/STRAIGHT LEADS (P080006/S030) | Medtronic, Inc. | 2011-07-07 |
| INTERSTIM FAMILY OF INS/LEAD/EXTENSION (P080025/S010) | Medtronic Neuromodulation | 2011-07-07 |
| CAPSURE/VITATRON CRYSTALINE/EXCELLENCE +/EXCELLENCE PS + LEADS (P830061/S067) | Medtronic Cardiac Rhythm Disease Management | 2011-07-07 |
| ADVISA IPG (P980035/S230) | Medtronic, Inc. | 2011-07-07 |
| DEMA IPGS/C & T SERIES IPGS (P990001/S089) | Medtronic, Inc. | 2011-07-07 |
| RF CONDUCTR MC/RF CONTACTR/RF ENHANCR II/RF MARINR MC 7F/SC 5F/RF MARNIR UNIPOLAR/RF CONDUCTR MC ABLATION CATHETERS (P930029/S031) | Medtronic, Inc. | 2011-07-07 |
| KAPPA 400 IPG (P970012/S086) | Medtronic, Inc. | 2011-07-07 |
| ATTAIN LEAD/CONSULTA CRT-P/INSYNC III/SYNCRA CRT-PS (P010015/S130) | Medtronic, Inc. | 2011-07-07 |
| VITATRON DA+C & VITATRON DA+T SERIES IPGS (P990001/S090) | Medtronic, Inc. | 2011-07-07 |
| SYNCHROMED II IMPLANTABLE INFUSION PUMP/INDURA 1P INTRATHECAL/SUTURELESS PUMP CONNECTOR REVISION/PROXIMAL CATHETER (P860004/S153) | Medtronic, Inc. | 2011-07-07 |
| Y ADAPTOR/EXTENDER KIT/DF-1 PORT PIN PLUG/IS-1 CONNECTOR PORT PIN PLUG KIT/TOOL/LEAD ADAPTOR/SPRINT QUATTRO/SUBCUTANEOUS (P920015/S079) | Medtronic, Inc. | 2011-07-07 |
| TRIFECTA VALVE (P100029/S006) | ABBOTT MEDICAL | 2011-07-07 |
| TRANSVENE CS/SVC LEAD (W/POLYURETHANE SHEATH) (P980050/S063) | Medtronic, Inc. | 2011-07-07 |
| CAPSUREFIX MRI (P090013/S027) | Medtronic, Inc. | 2011-07-07 |
| PROTECTA DR/VR/XT DR/VR ICD (P980016/S303) | Medtronic Cardiac Rhythm Disease Management | 2011-07-07 |
| CAPSURE LEAD/ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO/II ICDS (P980016/S304) | Medtronic Cardiac Rhythm Disease Management | 2011-07-07 |
| INTERSTIM FAMILY OF INS/LEADS/EXTENSION (P970004/S118) | Medtronic Neuromodulation | 2011-07-07 |
| RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD (P840001/S190) | Medtronic Neuromodulation | 2011-07-07 |
| LIFEVEST WEARABLE BEFIBRILLATOR (P010030/S028) | Zoll Manufacturing Corporation | 2011-07-07 |
| CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET S+/CAPSURE (P930039/S057) | Medtronic, Inc. | 2011-07-07 |
| ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS (P960009/S120) | Medtronic, Inc. | 2011-07-07 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S032) | Medtronic, Inc. | 2011-07-07 |
| ACCULINK CAROTID STENT SYSTEM (P040012/S040) | Abbott Vascular | 2011-07-07 |
| VITATRON LEGACY IPG (P850051/S075) | Medtronic, Inc. | 2011-07-07 |
| CONCERTO/CONCERTO II/CONSULTA/INSYNC II/III MARQUIS/MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT (P010031/S258) | Medtronic Cardiac Rhythm Disease Management | 2011-07-07 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 (P050028/S017) | Roche Molecular Systems, Inc. | 2011-07-07 |
| ESTEEM (P090018/S009) | Envoy Medical Corporation | 2011-07-07 |
| SELECTSECURE LEAD/SLEEVE KIT (P030036/S033) | Medtronic Cardiac Rhythm Disease Management | 2011-07-07 |
| CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT (P890003/S230) | Medtronic, Inc. | 2011-07-07 |
| PROTECTA/PROTECTA XT CRT-D (P010031/S257) | Medtronic Cardiac Rhythm Disease Management | 2011-07-07 |
| SYNVISC AND SYNVISC-ONE (P940015/S021) | Sanofi Genzyme Corp. | 2011-07-07 |
| DISPOABLE COVER & EPG SAFETY CABLE (P820003/S107) | Medtronic Cardiac Rhythm Disease Management | 2011-07-07 |
| CAPSURE FIX LEAD & REVO MRI IPG (P090013/S029) | Medtronic, Inc. | 2011-07-07 |
| MEDTRONIC 350 SERIES IPG/ADAPTA/ADVISA/AT500/ENPULSE/ENRHYTHM/RELIA/SENSIA/SIGMA/VERSA IPGS (P980035/S231) | Medtronic, Inc. | 2011-07-07 |
| INSYNC/ INSYNC III, CRT IPG'S (P010015/S128) | Medtronic, Inc. | 2011-07-07 |
| INTERSTIM II NEUROSTIMULATORS (P970004/S117) | Medtronic Neuromodulation | 2011-07-06 |
| ACTIVA FAMILY OF NEUROSTIMULATORS (P960009/S119) | Medtronic, Inc. | 2011-07-06 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S036) | Abbott Laboratories | 2011-07-06 |
| RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S189) | Medtronic Neuromodulation | 2011-07-06 |
| INTERSTIM II NEUROSTIMULATORS (P080025/S009) | Medtronic Neuromodulation | 2011-07-06 |
| ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S013) | Hologic, Inc. | 2011-07-05 |
| ZILVER VASCULAR STENT AND ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM (P050017/S006) | Cook Ireland, Ltd. | 2011-07-05 |