| SUPARTZ JOINT FLUID THERAPY (P980044/S009) | Seikagaku Corp. | 2009-07-08 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S020) | W. L. Gore & Associates, Inc. | 2009-07-08 |
| EP TECH EPT-1000XP RF ABLATION SYSTEM (P020025/S015) | Boston Scientific | 2009-07-08 |
| TELIGEN PULSE GENERATORS (P960040/S197) | Boston Scientific | 2009-07-07 |
| FREEZOR CARDIAC/FREEZOR XTRA/FREEZOR MAX SURGICAL CARDIAC CRYOABLATION CATHETER/CCT.2 CRYOCONSOLE SYSTEM (P020045/S026) | Medtronic Cryocath, LP | 2009-07-07 |
| SUPARTZ (P980044/S007) | Seikagaku Corp. | 2009-07-07 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S007) | Allergan | 2009-07-07 |
| COGNIS PULSE GENERATORS (P010012/S211) | Boston Scientific Corp | 2009-07-07 |
| ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022) | Hologic, Inc. | 2009-07-06 |
| AMS 800 URINARY CONTROL SYSTEM (P000053/S024) | Boston Scientific Corp | 2009-07-06 |
| NEXGEN COMPLETE KNEE SOLUTION/LEGACY KNEE - POSTERIOR STABILIZED (LPS)/LPS-FLEX MOBILE BEARING KNEE (P060037/S011) | Zimmer, Inc. | 2009-07-06 |
| MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM (P910077/S095) | Boston Scientific | 2009-07-06 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P070015/S019) | Abbott Vascular, Inc. | 2009-07-02 |
| DURATA/RIATA ST OPTIM/RIATA ST FAMILY OF LEADS (P950022/S061) | ABBOTT MEDICAL | 2009-07-02 |
| DURA STAR RX PTCA BALLOON DILATATION CATHETER (P880003/S096) | Cordis Corp. | 2009-07-02 |
| PREPSTAIN SYSTEM (P970018/S016) | Bd Diagnostic Systems | 2009-07-02 |
| EUFLEXXA 1% SODIUM HYALURONATE (P010029/S007) | Ferring Pharmaceuticals, Inc. | 2009-07-01 |
| CRYSTALENS MODEL AT-45 ACCOMMODATING INTRACULAR LENS (IOL) (P030002/S019) | Bausch & Lomb, Inc. | 2009-06-30 |
| CONTAK RENEWAL (P010012/S215) | Boston Scientific Corp | 2009-06-30 |
| 1888 TENDRIL LEADS (P960013/S043) | ABBOTT MEDICAL | 2009-06-29 |
| MACROPLASTIQUE IMPLANTS (P040050/S003) | Uroplasty, LLC | 2009-06-26 |
| COGNIS FAMILY (P010012/S214) | Boston Scientific Corp | 2009-06-26 |
| BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION (P990027/S012) | Technolas Perfect Vision GmbH | 2009-06-26 |
| ACUITY STEERABLE LEAD (P050046/S004) | Guidant Corp. | 2009-06-26 |
| THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S007) | Srs Medical | 2009-06-26 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S014) | Cryolife, Inc. | 2009-06-26 |
| TELIGEN FAMILY (P960040/S200) | Boston Scientific | 2009-06-26 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S013) | W. L. Gore & Associates, Inc. | 2009-06-25 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S018) | Boston Scientific Corp | 2009-06-25 |
| ACUITY SPIRAL LEAD (P010012/S182) | Boston Scientific Corp | 2009-06-25 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S015) | Abbott Laboratories | 2009-06-24 |
| C & T SERIES IPG & DEMA FAMILIES (P990001/S050) | Medtronic, Inc. | 2009-06-24 |
| INSYNC & INSYNC II CRT-P (P010015/S062) | Medtronic, Inc. | 2009-06-24 |
| COAPTITE INJECTABLE IMPLANT (P040047/S013) | Merz North America, Inc. | 2009-06-24 |
| MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II/SECURA/VIRTUOSO II FAMILIES OF ICDS (P980016/S179) | Medtronic Cardiac Rhythm Disease Management | 2009-06-24 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S030) | Boston Scientific Corp | 2009-06-24 |
| KAPPA 400 DR/SR IPG (P970012/S051) | Medtronic, Inc. | 2009-06-24 |
| ST JUDE MEDICAL BIOCOR/BIOCOR SUPRA/EPIC/EPIC SUPRA HEART VALVES (P040021/S009) | ABBOTT MEDICAL | 2009-06-24 |
| KAPPA IPGS, SIGMA IPGS, ENPULSE IPGS, ENRHYTHM IPGS, AT500 PACING SYSTEM, ADAPTA/SENSIA/VERSA IPGS AND RELIA IPG (P980035/S128) | Medtronic, Inc. | 2009-06-24 |
| INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S013) | ETHICON, Inc. | 2009-06-24 |
| ENRHYTHM IPG FAMILY (P980035/S136) | Medtronic, Inc. | 2009-06-24 |
| PRODIGY IPG (P890003/S164) | Medtronic, Inc. | 2009-06-24 |
| ENTRUST ICD (P980016/S191) | Medtronic Cardiac Rhythm Disease Management | 2009-06-24 |
| UROLOGIX TARGIS SYSTEM (P970008/S044) | Urologix, LLC | 2009-06-24 |
| INSYNC/CONCERTO/MAXIMO/CONSULTA FAMILIES OF ICDS & CRT-DS (P010031/S143) | Medtronic Cardiac Rhythm Disease Management | 2009-06-24 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S020) | Abbott Vascular, Inc. | 2009-06-23 |
| ABBOTT ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS (P060035/S001) | Abbott Laboratories | 2009-06-23 |
| ARCHITECT ANTI-HCV ASSAY/CALIBRATOR/CONTROL (P050042/S005) | Abbott Laboratories, Inc. | 2009-06-23 |
| PRISMA TPE 2000 SET (P830063/S005) | Vantive US Healthcare, LLC | 2009-06-19 |
| PROLIEVE THERMODILITATION SYSTEM (P030006/S021) | Medifocus, Inc. | 2009-06-19 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S091) | Boston Scientific Corp | 2009-06-19 |
| EMDOGAIN (P930021/S011) | The Straumann Company | 2009-06-19 |
| CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S027) | Bayer Pharma AG | 2009-06-19 |
| MINILINK REAL-TIME TRANSMITTER & CGMS IPRO DIGITAL RECORDER (P980022/S046) | Medtronic Minimed | 2009-06-19 |
| ZIMMER NEXGEN LPS-FLEX MOBILE/LPS-MOBILE BEARING KNEE SYSTEMS (P060037/S010) | Zimmer, Inc. | 2009-06-19 |
| ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S007) | Spectranetics Corp. | 2009-06-19 |
| GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S027) | Gynecare, Inc. | 2009-06-19 |
| VISTAKON (SENOFILCON A) CONTACT LENSES (P040045/S005) | Vistakon, Division of Johnson & Johnson Vision Car | 2009-06-19 |
| TECNIS MULTIFOCAL FOLDABLE ACRYLIC INTRAOCULAR LENS (P080010/S002) | Johnson & Johnson Surgical Vision, Inc. | 2009-06-19 |
| CADENCE FAMILY OF ICDS (P910023/S211) | ABBOTT MEDICAL | 2009-06-18 |
| MODEL 3550-31 SNAP-LID SCREENING CONNECTOR CABLE (P840001/S138) | Medtronic Neuromodulation | 2009-06-18 |
| SMART CONTROL NITINOL STENT SYSTEM (P020036/S015) | Cordis US Corporation | 2009-06-18 |
| CORDIS PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS (P030047/S018) | Cordis US Corporation | 2009-06-18 |
| EPIC HF/ATLAS+HF FAMILY OF CRT-DS (P030054/S126) | ABBOTT MEDICAL | 2009-06-18 |
| SJM DURATA, RIATA ST OPTIM & RIATA ST FAMILIES OF DEFIBRILLATION LEADS (P950022/S055) | ABBOTT MEDICAL | 2009-06-18 |
| THERAPY DUAL 8/THERAPY & SAFIRE TX ABLATION CATHETERS (P040042/S013) | Irvine Biomedical,Inc.(Ibi) | 2009-06-17 |
| THERAPY CARDIAC ABLATION CATHETERS (P040014/S008) | Irvine Biomedical, Inc. | 2009-06-17 |
| INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO/MAXIMO II/CONSULTA/CONCERTO II CRT (P010031/S155) | Medtronic Cardiac Rhythm Disease Management | 2009-06-17 |
| MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/VIRTUOSO II/MAXIMO II/SECURA FAMILIES OF ICDS (P980016/S194) | Medtronic Cardiac Rhythm Disease Management | 2009-06-17 |
| MINILINK REAL-TIME TRANSMITTER & CGMS IPRO DIGITAL RECORDER (P980022/S055) | Medtronic Minimed | 2009-06-16 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P070015/S018) | Abbott Vascular, Inc. | 2009-06-16 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS (P030026/S018) | Ortho-Clinical Diagnostics, Inc. | 2009-06-12 |
| COGNIS CRT-DS (P010012/S209) | Boston Scientific Corp | 2009-06-12 |
| TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (P080010/S001) | Johnson & Johnson Surgical Vision, Inc. | 2009-06-12 |
| THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF ABLATION GENERATOR (P060019/S005) | Irvine Biomedical, Inc. | 2009-06-12 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S081) | Advanced Bionics | 2009-06-12 |
| ACCENT/ZEPHYR/ VICTORY PACEMAKERS (P880086/S175) | ABBOTT MEDICAL | 2009-06-12 |
| ANTHEM/FRONTIER II CRT-PS (P030035/S055) | ABBOTT MEDICAL | 2009-06-12 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S075) | Advanced Bionics | 2009-06-12 |
| TELIGEN ICDS (P960040/S195) | Boston Scientific | 2009-06-12 |
| SONATATI100 IMPLANT (P000025/S042) | Med-El Corp. | 2009-06-12 |
| ESPRIT MODELS SR AND DR PACEMAKER SYSTEMS WITH THE PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.16 UG1 (P950029/S041) | MicroPort CRM USA, Inc. | 2009-06-11 |
| CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S025) | Bayer Pharma AG | 2009-06-11 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S019) | W. L. Gore & Associates, Inc. | 2009-06-10 |
| ADVIA CENTAUR XP PSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE) (P950021/S011) | Siemens Healthcare Diagnostics | 2009-06-10 |
| RESTOR POSTERIOR CHAMBER INTRAOCULAR LENSES (P040020/S017) | Alcon Research, Ltd. | 2009-06-10 |
| RESTYLANE AND PERLANE INJECTABLE GELS (P040024/S040) | Q-Med AB | 2009-06-10 |
| RF CONDUCTR ABLATION CATHETERS (P930029/S022) | Medtronic, Inc. | 2009-06-10 |
| ENDOTAK RELIANCE TACHY LEAD (P910073/S078) | Boston Scientific | 2009-06-10 |
| ADVIA CENTAUR XP CPSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE) (P990055/S012) | Siemens Healthcare Diagnostics | 2009-06-10 |
| GELFOAM PLUS HEMOSTASIS KIT (N18286/S018) | Pfizer, Inc. | 2009-06-10 |
| PROMOTE/PROMOTE+ CRT-D (P030054/S125) | ABBOTT MEDICAL | 2009-06-10 |
| ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES (P930014/S033) | Alcon Laboratories, Inc. | 2009-06-10 |
| ACRYSOF TORIC INTRAOCULAR LENSES (P930014/S032) | Alcon Laboratories, Inc. | 2009-06-10 |
| ADVIA CENTAUR ANTI-HBS (AHBS) (P030029/S004) | Siemens Healthcare Diagnostics | 2009-06-10 |
| ACRYSOF IQ RESTOR INTRAOCULAR LENSES (P040020/S016) | Alcon Research, Ltd. | 2009-06-10 |
| CURRENT/CURRENT+ ICD (P910023/S210) | ABBOTT MEDICAL | 2009-06-10 |
| BIRMINGHAM HIP RESURFACING SYSTEM (P040033/S011) | Smith & Nephew, Inc. | 2009-06-09 |
| COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING (P840062/S019) | Integra Lifesciences Corp. | 2009-06-09 |
| ACTIVARC AND ACTIVAPC (P960009/S067) | Medtronic, Inc. | 2009-06-08 |