| PRISMAFLEX M150 SET (K080519) | Gambro Renal Products, Inc. | 2008-06-13 |
| GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE (K081454) | Possis Medical, Inc. | 2008-06-13 |
| WATERLASE, VERSION 3.0 (K081589) | Biolase Technology, Inc. | 2008-06-13 |
| RANGE SPINAL SYSTEM, LARGE DENALI SCREWS (K081381) | K2m, Inc. | 2008-06-13 |
| D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT (K081164) | Diagnostic Hybrids, Inc. | 2008-06-13 |
| SURGICRAFT SCREW FIXATION SYSTEM (K080447) | Surgicraft , Ltd. | 2008-06-13 |
| BARD DIGNICARE STOOL MANAGEMENT SYSTEM (K073598) | C.R. Bard, Inc. | 2008-06-13 |
| ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM (K073416) | Arkray Factory USA, Inc. | 2008-06-13 |
| SWC/DWC WARMING CABINETS (K080609) | Mac Medical | 2008-06-13 |
| ETHICON ENDO SURGERY ARTICULATING SNARE (K073288) | Ethicon Endo-Surgery, Inc. | 2008-06-12 |
| ENDSNOR (K072731) | Dockstader Orthodontic Lab, Inc. | 2008-06-12 |
| SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2 (K081469) | Sectra Imtec AB | 2008-06-12 |
| OPTIMA PET/CT 560 (K081496) | Ge Medical Systems, LLC | 2008-06-12 |
| USHIFU STEPPER (K080970) | Ushifu Development Company, LLC | 2008-06-11 |
| ALZ WEB PACS, VERSION 1.0 (K081304) | Alz, Inc. | 2008-06-11 |
| SATURN 9000-810 (K080589) | New Medical Co., Ltd. | 2008-06-11 |
| GC OPB-100 (K080724) | GC America, Inc. | 2008-06-11 |
| DESKTOP PRO (K080585) | Elekta , Ltd. | 2008-06-11 |
| SIGMA SERIES HYPERBARIC CHAMBER (K072427) | Perry Baromedical Corp. | 2008-06-11 |
| CSBP-001A BODY ORGAN PERFUSION SYSTEM (K081482) | Toshiba America Medical Systems, In.C | 2008-06-11 |
| PRECISION 500D R&F X-RAY SYSTEM (K081091) | GE Healthcare | 2008-06-11 |
| VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY (K080931) | bioMerieux, Inc. | 2008-06-11 |
| MODEIFICATION TO IPLAN RT DOSE (K080888) | Brainlab AG | 2008-06-11 |
| SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER (K080330) | Biomet, Inc. | 2008-06-11 |
| VERTEX RECONSTRUCTION SYSTEM (K081297) | Medtronic Sofamor Danek | 2008-06-11 |
| RESICEM (K080517) | Shofu Dental Corp. | 2008-06-11 |
| BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS (K080088) | Biomet Manufacturing, Inc. | 2008-06-11 |
| BROWNE OPA TEST STRIP (K081427) | STERIS Corporation | 2008-06-11 |
| MODIFICATION TO INREACH SYSTEM (K081379) | Superdimension, Ltd. | 2008-06-11 |
| MODIFICATION TO RETINAL FUNCTION IMAGER (RFI) (K080180) | Optical Imaging , Ltd. | 2008-06-11 |
| VINTAGE ART (K080834) | Shofu Dental Corp. | 2008-06-11 |
| CURE CATHETER CLOSED SYSTEM (K080881) | Cure Medical, LLC | 2008-06-11 |
| 21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A) (K081242) | Tokotu Electric Co., Ltd. | 2008-06-11 |
| T2 FEMORAL NAIL (K081152) | Howmedica Osteonics Corp. | 2008-06-10 |
| SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS (K080755) | Bausch & Lomb, Inc. | 2008-06-10 |
| ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM (K081332) | Signus Medizintechnik GmbH | 2008-06-10 |
| INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE (K080673) | Vertebral Technologies, Inc. | 2008-06-10 |
| MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 (K080550) | Minos Medical | 2008-06-10 |
| KYMCO FORU, MODEL EQ40 (K081133) | Kwang Yang Motor Co., Ltd. | 2008-06-10 |
| WG-SURGICAL SUTURES WITH NEEDLE (K080684) | Foosin Medical Supplies, Inc. | 2008-06-09 |
| MARTIN CHAIR, MODEL C4S1 (K080506) | Martin Manufacturing Co., LLC | 2008-06-09 |
| NEB-U-MASK SYSTEM, MODELS 1895, 1896 (K080230) | Teleflexmedical, Inc. | 2008-06-09 |
| NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 (K080175) | Datascope Corp., Patient Monitoring Division | 2008-06-09 |
| CONNEXX LOCKING TIBIA NAIL (K080706) | I.T.S. Implantat-Technologie-Systeme GmbH | 2008-06-09 |
| MOSAIC LASER SYSTEM (K080932) | Lutronic Corporation | 2008-06-09 |
| ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG (K073501) | Roche Diagnostics Corp. | 2008-06-09 |
| WATCH-PAT 200I (WP200I) (K081037) | Itamar Medical | 2008-06-09 |
| DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES (K080366) | Zefon Intl. | 2008-06-09 |
| SL-PLUS STANDARD AND LATERAL HIP STEMS (K072852) | Smith & Nephew, Inc. | 2008-06-09 |
| HE4 EIA, MODEL: 404-10 US (K072939) | Fujirebio Diagnostics,Inc. | 2008-06-09 |
| THOR ANTERIOR PLATING SYSTEM (K080773) | Stryker Spine | 2008-06-09 |
| TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE (K081003) | Sutures India Pvt., Ltd. | 2008-06-09 |
| PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE (K081001) | Sutures India Pvt., Ltd. | 2008-06-09 |
| SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585 (K073179) | Maquet Critical Care AB | 2008-06-09 |
| ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM (K081318) | Lifescan, Inc. | 2008-06-09 |
| CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM (K080014) | Taidoc Technology Corporation | 2008-06-09 |
| MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE (K081002) | Sutures India Pvt., Ltd. | 2008-06-09 |
| PREFERENCE PEDICLE SCREW SYSTEM (K081296) | Us Spine | 2008-06-06 |
| SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 (K073712) | Adroit Medical Systems, Inc. | 2008-06-06 |
| NERVE MONITORING CABLE (K073229) | Pioneer Surgical Technology | 2008-06-06 |
| ZIRKONDENT (K080146) | Ergometa | 2008-06-06 |
| APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2 (K081065) | Toshiba America Medical Systems, In.C | 2008-06-06 |
| PROVEN STEM EXTENDER (K081458) | Stelkast Company | 2008-06-06 |
| COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE (K080677) | Kaltenbach & Voigt GmbH & Co. | 2008-06-06 |
| X-VOID, SPIDER (K072198) | Sintea Biotech, Inc. | 2008-06-06 |
| TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS (K080269) | Biosite Incorporated | 2008-06-06 |
| ERGO++ VERSION 1.7 (K080601) | 3D Line Medical Systems S.R.L. | 2008-06-06 |
| UNI-KNEE 2.0 (K080678) | Brainlab AG | 2008-06-06 |
| NILIMEDIX ADI (K070844) | Nilimedix , Ltd. | 2008-06-06 |
| TR-USB TELEPHONIC STETHOSCOPE (K081032) | Rnk Products, Inc. | 2008-06-06 |
| AVIATOR TRANSPORT INCUBATOR (K081399) | International Biomedical, Ltd. | 2008-06-06 |
| HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER (K080384) | The Binding Site, Ltd. | 2008-06-06 |
| GRADIA FORTE (K080478) | GC America, Inc. | 2008-06-05 |
| FINGER PULSE OXIMETER, MODEL 9560 (K081285) | Nonin Medical, Inc. | 2008-06-05 |
| MERCI RETRIEVER (K081305) | Concentric Medical, Inc. | 2008-06-05 |
| FUJIFILM FCR VIEW, MODEL CR-VW674 (K081308) | Fujifilm Medical Systems U.S.A, Inc. | 2008-06-04 |
| VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) (K073155) | Vitalograph (Ireland) , Ltd. | 2008-06-04 |
| 21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A) (K081055) | Totoku Electric Co., Ltd. | 2008-06-04 |
| DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 (K071597) | Dade Behring, Inc. | 2008-06-04 |
| MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM (K081121) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008-06-04 |
| 21.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A) (K081056) | Totoku Electric Co., Ltd. | 2008-06-04 |
| STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM (K073109) | Surgicraft , Ltd. | 2008-06-04 |
| POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER (K081311) | C.R. Bard, Inc. | 2008-06-04 |
| FOXCROSS PTA CATHETER (K081417) | Abbott Vascular, Inc. | 2008-06-04 |
| DRF 4343 (K080859) | Villa Sistemi Medicali S.P.A. | 2008-06-04 |
| DVX SPINE SYSTEM (K080876) | Bk Meditech, Co., Ltd. | 2008-06-04 |
| MRI PATIENT POSITIONING DEVICES (K080072) | CIVCO Medical Instruments Co., Inc. | 2008-06-04 |
| NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE (K081426) | Philips Medical Systems (Cleveland), Inc. | 2008-06-04 |
| FEEL-FINE INSULIN PEN NEEDLE (K080904) | Feel Tech | 2008-06-04 |
| FALCK APPLANATION TONOMETER (FAT2) (K071755) | Falck Medical, Inc. | 2008-06-03 |
| REJUVENATE MODULAR HIP SYSTEM (K081044) | Howmedica Osteonics Corp. | 2008-06-03 |
| ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER (K081449) | Ultimed, Inc. | 2008-06-03 |
| BONEMEDIK-DM (K080772) | Meta Biomed Co., Ltd. | 2008-06-03 |
| ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM (K081097) | Orthopediatrics, LLC | 2008-06-03 |
| FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM (K073708) | Precision Surgery , Ltd. | 2008-06-03 |
| SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS) (K080555) | Ivu Imaging Corporation | 2008-06-03 |
| NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600, (K072080) | Smiths Medical Asd, Inc. | 2008-06-02 |
| ACCIN UNIPOLAR HEAD SYSTEM (K080539) | Accelerated Innovation, LLC | 2008-06-02 |
| BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK (K080703) | 4m Ventures, Inc. | 2008-06-02 |
| SOMATOM DEFINITION, MODEL AS/AS+ (K081022) | Siemens Medical Solutions USA, Inc. | 2008-06-02 |