| ACUITY STEERABLE LEAD (P050046/S002) | Guidant Corp. | 2008-03-05 |
| POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER (P040002/S014) | Endologix, LLC | 2008-03-05 |
| MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S005) | Mentor Corp. | 2008-03-05 |
| AMPLATZER DUCT OCCLUDER (P020024/S019) | ABBOTT MEDICAL | 2008-03-05 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS (P030026/S014) | Ortho-Clinical Diagnostics, Inc. | 2008-03-05 |
| AMPLATZER MUSCULSR VSD OCCLUDER (P040040/S004) | ABBOTT MEDICAL | 2008-03-05 |
| SOFTCON EW 2 & SOFT-55 EW APHAKIC SOFT CONTACT LENSES (P960039/S003) | Unilens Corporation, USA | 2008-03-03 |
| SOF-FORM 55 EW AND LL-55 SOFT HYDROPHILIC SPHERICAL CONTACT LENSES (P890040/S006) | Unilens Corp., USA | 2008-03-03 |
| BD OVD 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY (P960011/S013) | Altacor , Ltd. | 2008-02-29 |
| LINOX SD, TD & S/T (P980023/S030) | Biotronik, Inc. | 2008-02-29 |
| VNS THERAPY SYSTEM (P970003/S097) | LivaNova USA, Inc. | 2008-02-29 |
| SELOX ST/JT, SETROX S & DEXTRUS (P950037/S056) | Biotronik, Inc. | 2008-02-29 |
| MEDTRONIC RESTORE FAMILY IMPLANTABLE NEUROSTIMULATORS (P840001/S100) | Medtronic Neuromodulation | 2008-02-29 |
| ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE KNEE SYSTEMS (P060037/S001) | Zimmer, Inc. | 2008-02-28 |
| LIBERTE CORONARY STENT SYSTEM (P030025/S053) | Boston Scientific Corp | 2008-02-27 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S041) | Boston Scientific Scimed, Inc. | 2008-02-27 |
| AMPLATZER SEPTAL OCCLUDER AND MULTI-FENESTRATED SEPTAL OCCLUDER (P000039/S024) | ABBOTT MEDICAL | 2008-02-27 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S003) | ABBOTT MEDICAL | 2008-02-27 |
| MAVERICK2 MONORAIL AND MAVERICK OTW PTCA CATHETER, QUANTUM MAVERICK PTCA CATHETER (P860019/S222) | Scimed Life Systems, Inc. | 2008-02-27 |
| RADIESSE INJECTABLE IMPLANT (P050037/S006) | Merz North America, Inc. | 2008-02-27 |
| MODEL SA40N ARRAY MULTIFOCAL ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P960028/S029) | Johnson & Johnson Surgical Vision, Inc. | 2008-02-27 |
| ARRAY MULTIFOCAL ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P960028/S028) | Johnson & Johnson Surgical Vision, Inc. | 2008-02-27 |
| ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOL) (P880081/S036) | Johnson & Johnson Surgical Vision, Inc. | 2008-02-27 |
| TAXUS? EXPRESS2 PACLITAXEL ELUTING STENT SYSTEM (P040016/S028) | Boston Scientific Scimed, Inc. | 2008-02-27 |
| RADIESSE INJECTABLE IMPLANT (P050052/S007) | Merz North America, Inc. | 2008-02-27 |
| DUCT OCCLUDER (P020024/S018) | ABBOTT MEDICAL | 2008-02-27 |
| ACCESS HYBRITECH PSA IMMUNOASSAY (P850048/S023) | Beckman Coulter, Inc. | 2008-02-26 |
| PREVELLE SILK (P030032/S007) | Genzyme Biosurgery | 2008-02-26 |
| CRT'S (P030054/S054) | ABBOTT MEDICAL | 2008-02-25 |
| OXFORD PARTIAL KNEE (P010014/S018) | Biomet Manufacturing Corp | 2008-02-25 |
| GORE TAG THORACIC ENDOPROTHESIS (P040043/S017) | W. L. Gore & Associates, Inc. | 2008-02-25 |
| CONTAK RENEWAL RF HEART FAILURE PULSE GENERATORS (P010012/S171) | Boston Scientific Corp | 2008-02-25 |
| EASYTRAK 2 (P010012/S172) | Boston Scientific Corp | 2008-02-25 |
| ICD'S (P910023/S136) | ABBOTT MEDICAL | 2008-02-25 |
| VNS THERAPY SYSTEM (P970003/S096) | LivaNova USA, Inc. | 2008-02-22 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S022) | St Jude Medical | 2008-02-22 |
| ABBOTT AXSYM ANTI-HCV (P970027/S006) | Abbott Laboratories | 2008-02-22 |
| CARELINK PROGRAMMER, MODEL 2090 (P890003/S134) | Medtronic, Inc. | 2008-02-21 |
| POWERLINK SYSTEM ANEURYSM STENT GRAFT (P040002/S013) | Endologix, LLC | 2008-02-21 |
| KAPPA 700/600,650,800/900 FAMILY, SIGMA FAMILY, MEDTRONIC 350 SERIES, ENPILSE 2 FAMILY ENRHYTHM, ADAPTA/VERSA/SESIA FAM (P980035/S086) | Medtronic, Inc. | 2008-02-21 |
| KAPPA 400 DR, KAPPA 400 SR (P970012/S033) | Medtronic, Inc. | 2008-02-21 |
| BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSCH & LOMB VISION SHAPING TREATMENT (P010062/S006) | Bausch & Lomb | 2008-02-21 |
| BOSTON EQUALENS (ITAFLUOROFOCON A) RIGID GAS PERMEABLE CONTACT LENS, EQUALENS 2 (OPRIFOCON A) RIGID GAS PERMEARABLE LENS (P860022/S057) | Bausch & Lomb | 2008-02-21 |
| MARQUIS, MAXIMO, INTRINSIC FAMILY, ONYX, VIRTUOSO, ENTRUST FAMILY, (P980016/S122) | Medtronic Cardiac Rhythm Disease Management | 2008-02-21 |
| INSYNC PULSE GENERATOR, INSYNC 3 PULSE GENERATOR (P010015/S037) | Medtronic, Inc. | 2008-02-21 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S027) | Abbott Vascular | 2008-02-21 |
| C-SERIES DEVICES AND T-SERIES DEVICES (P990001/S035) | Medtronic, Inc. | 2008-02-21 |
| INSYNC MARQUIS, INSYNC 2 & 3 MARQUIS, INSYNC 2 &3 PROTECT INSYNC SENTRY FAMILY, INSYNC MAXIMO FAMILY, CONCERTO (P010031/S092) | Medtronic Cardiac Rhythm Disease Management | 2008-02-21 |
| PARADIGM REAL-TIME PUMP (P980022/S025) | Medtronic Minimed | 2008-02-21 |
| PRODIGY (P890003/S136) | Medtronic, Inc. | 2008-02-21 |
| PREVAIL (P850051/S067) | Medtronic, Inc. | 2008-02-21 |
| AFFINITY, IDENTITY, INTEGRITY & VICTORY/ZEPHYR FAMILY OF DEVICES (P880086/S159) | ABBOTT MEDICAL | 2008-02-20 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR (P000044/S017) | Ortho-Clinical Diagnostics, Inc. | 2008-02-20 |
| OXFORD MENISCAL UNICOMPARTMENTAL KNEE (P010014/S017) | Biomet Manufacturing Corp | 2008-02-20 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS (P010021/S012) | Ortho-Clinical Diagnostics, Inc. | 2008-02-20 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATORS (P030024/S008) | Ortho-Clinical Diagnostics | 2008-02-20 |
| VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI HB-S QUANTITATIVE REAGENT PACK & CALIBRATORS (P000014/S016) | Ortho-Clinical Diagnostics, Inc. | 2008-02-20 |
| DRIVER AND MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S013) | Medtronic, Ireland | 2008-02-15 |
| LIVIAN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (P010012/S154) | Boston Scientific Corp | 2008-02-15 |
| MEDTRONIC VASCULAR ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S030) | Medtronic Vascular | 2008-02-15 |
| MEDTRONIC ATTAIN OTW LV LEAD MODEL 4193 (P010015/S030) | Medtronic, Inc. | 2008-02-14 |
| DURATA LEADS (P950022/S050) | ABBOTT MEDICAL | 2008-02-14 |
| INFUSE BONE GRAFT (P050053/S007) | Medtronic, Inc. | 2008-02-14 |
| XACT CAROTID STENT SYSTEM (P040038/S012) | Abbott Vascular, Inc. | 2008-02-14 |
| MEL 80 EXCIMER LASER SYSTEM (P060004/S002) | Carl Zeiss Meditec, Inc. | 2008-02-14 |
| VENTAK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P960040/S147) | Boston Scientific | 2008-02-13 |
| VITALITY & VITALITY 2 DEVICE FAMILY (P960040/S160) | Boston Scientific | 2008-02-13 |
| HER2 FISH PHARMDX KIT (P040005/S002) | Agilent Technologies Singapore (International) Pte , Ltd. | 2008-02-13 |
| DRIVER OVER THE WIRE (OTW) & DRIVER MULTI-EXCHANGE (MX) CORONARY STENT SYSTEMS (P030009/S018) | Medtronic, Ireland | 2008-02-13 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S004) | W. L. Gore & Associates, Inc. | 2008-02-13 |
| SYMPHONY & ELA RHAPSODY PACEMAKERS (P950029/S033) | MicroPort CRM USA, Inc. | 2008-02-13 |
| TOP2A FISH PHARMDX KIT (P050045/S001) | Dako Denmark A/S | 2008-02-13 |
| DEFLUX INJECTABLE GEL (P000029/S036) | Palette Life Sciences | 2008-02-13 |
| DEFLUX INJECTABLE GEL (P000029/S035) | Palette Life Sciences | 2008-02-13 |
| LOTRAFILCON A & B SOFT CONTACT LENSES (P010019/S008) | Alcon Laboratories, Inc. | 2008-02-12 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S007) | Ortho-Clinical Diagnostics | 2008-02-12 |
| THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S001) | Srs Medical | 2008-02-12 |
| EASYTRAK 3 FAMILY OF LEADS (P010012/S167) | Boston Scientific Corp | 2008-02-11 |
| AT 500 IPG & ENRHYTHM IPG (P980035/S077) | Medtronic, Inc. | 2008-02-08 |
| INSYNC FAMILIES OF ICD & CONCERTO ICD (P010031/S079) | Medtronic Cardiac Rhythm Disease Management | 2008-02-08 |
| CONTINUOUS SUBCUTANEOUS GLUCOSE MONITORING SYSTEM (P980022/S024) | Medtronic Minimed | 2008-02-08 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S046) | Cordis Corp. | 2008-02-08 |
| MENTOR MEMORYGEL GEL-FILLED BREAST IMPLANTS (P030053/S002) | Mentor Corp. | 2008-02-08 |
| VOYAGER RX CORONARY DILATATION CATHETER (P810046/S225) | Advanced Cardiovascular Systems, Inc. | 2008-02-08 |
| LUMAX FAMILY OF ICDS AND CRT-DS (P050023/S010) | Biotronik, Inc. | 2008-02-08 |
| INSYNC III CRT-P (P010015/S032) | Medtronic, Inc. | 2008-02-08 |
| LOTRAFILCON SOFT CONTACT LENSES (P010019/S007) | Alcon Laboratories, Inc. | 2008-02-08 |
| GEM III AT ICD (P980050/S029) | Medtronic, Inc. | 2008-02-08 |
| VARIOUS FAMILES OF ICDS (P980016/S109) | Medtronic Cardiac Rhythm Disease Management | 2008-02-08 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S021) | W. L. Gore & Associates, Inc. | 2008-02-07 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S033) | W. L. Gore & Associates, Inc. | 2008-02-07 |
| ANS GENESIS NEUROSTIMULATION (IPG) SYSTEM (P010032/S024) | ABBOTT MEDICAL | 2008-02-07 |
| ADEPT ADHESION REDUCTION SOLUTION (P050011/S001) | Baxter Healthcare Corp | 2008-02-07 |
| ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S007) | Alcon Research, Ltd. | 2008-02-06 |
| MEDTRONIC SPRINT LEADS (P920015/S038) | Medtronic, Inc. | 2008-02-06 |
| COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S014) | Roche Molecular Systems, Inc. | 2008-02-06 |
| AMPLICOR HCV TEST, VERSION 2.0 (P000010/S010) | Roche Molecular Systems, Inc. | 2008-02-06 |
| RENEWAL & VITALITY FAMILY OF ICDS (P010012/S170) | Boston Scientific Corp | 2008-02-06 |
| RENEWAL & VITALITY FAMILY OF ICDS (P960040/S159) | Boston Scientific | 2008-02-06 |
| ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPINCTER (P010020/S008) | Boston Scientific Corp | 2008-02-05 |