| METHA HIP SYSTEM (K071916) | Aesculap Implant Systems, Inc. | 2008-06-02 |
| CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC (K080973) | Cliniqa Corporation | 2008-06-02 |
| IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM (K063723) | Abiomed, Inc. | 2008-05-30 |
| EXPEDIUM 4.5MM SPINE SYSTEM (K081252) | Depuy Spine, Inc. | 2008-05-30 |
| MUCOGRAFT COLLAGEN MATRIX (K073711) | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2008-05-30 |
| SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS (K081034) | Synergeyes, Inc. | 2008-05-30 |
| NANOCOMPOSITE RESTORATIVE KIT (K080480) | Dmg USA, Inc. | 2008-05-30 |
| I-MINI DENTAL IMPLANT (K080115) | Oco Biomedical | 2008-05-30 |
| TSO3 OZONE STERILIZATION WRAP (K080198) | Tso3, Inc. | 2008-05-30 |
| GORE INFINIT MESH (K081069) | W. L. Gore & Associates, Inc. | 2008-05-30 |
| COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE (K080386) | Columbia Scientific Development, LLC | 2008-05-30 |
| TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT (K080763) | Talley Medical | 2008-05-30 |
| SECURE IMPLANT SYSTEM (2.5/3.0MM) (K080129) | Dio Department Dsi, Inc. | 2008-05-30 |
| PROVOX MICRON HME (K072582) | Atos Medical AB | 2008-05-30 |
| RAPID TOX CUP (K073078) | American Bio Medica Corp. | 2008-05-30 |
| ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM (K072178) | Zeus Scientific, Inc. | 2008-05-30 |
| BARD E LUMINEXX BILIARY STENT (K063532) | Bard Peripheral Vascular, Inc. | 2008-05-30 |
| AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 (K081035) | Osypka Medical, Inc. | 2008-05-30 |
| SCIENT'X TRIBECA VBR (K080588) | Scient'X USA, Inc. | 2008-05-30 |
| IVENT 2001 MRI CONDITIONAL (K073694) | Versamed Medical Systems, Inc. | 2008-05-30 |
| MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY (K073051) | Medrad, Inc. | 2008-05-30 |
| UREA/BUN, SCAL, NORTROL, ABTROL (K073295) | Thermofisher Scientific OY | 2008-05-29 |
| GENESIS ECP (K081359) | Scottcare Corporation | 2008-05-29 |
| INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) (K081194) | Rsb Spine, LLC | 2008-05-29 |
| 15-INCH (38 CM) COLOR LCD MONITOR CDL1576A (K080952) | Totoku Electric Co., Ltd. | 2008-05-29 |
| VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM (K081102) | Visionsense, Ltd. | 2008-05-29 |
| LDR SPINE ROI-C IMPLANT (K080728) | Ldr Spine USA | 2008-05-29 |
| PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS (K072290) | Dima Italia Srl | 2008-05-29 |
| 19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A (K080951) | Totoku Electric Co., Ltd. | 2008-05-29 |
| CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR (K081257) | Card Guard Scientific Survival , Ltd. | 2008-05-29 |
| CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM (K080860) | Creaspine | 2008-05-29 |
| PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR, CANNULA ANCHOR (K080161) | Patton Surgical Corp. | 2008-05-29 |
| OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM (K073006) | Takiron Co., Ltd. | 2008-05-29 |
| PALOMAR ASPIRE LASER PLATFORM (K081416) | Palomar Medical Products, Inc. | 2008-05-29 |
| OMEGA 3 TROCHANTERIC STABILIZING PLATE (K081278) | Howmedica Osteonics Corp. | 2008-05-29 |
| HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861 (K080424) | Hygia Health Services, Inc. | 2008-05-28 |
| DESTINATION RENAL GUIDING SHEATH (K081045) | Terumo Medical Corp. | 2008-05-28 |
| UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE (K080551) | University of Utah Hospitals and Clinics | 2008-05-28 |
| WBR XPRESS3.CARDIAC (K081201) | Ultraspect , Ltd. | 2008-05-28 |
| REVERE UNIPLANAR SCREWS (K081195) | Globus Medical, Inc. | 2008-05-28 |
| PROSTATE TISSUE MARKER (K081170) | Senorx, Inc. | 2008-05-28 |
| SURESKIN SILVER BANDAGES (K081274) | Euromed, Inc. | 2008-05-28 |
| ILUMA VISION (K081347) | Imtec Corp. | 2008-05-28 |
| MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER (K081220) | Angioscore, Inc. | 2008-05-28 |
| NRG TRANSSEPTAL NEEDLE (K073326) | Baylis Medical Co., Inc. | 2008-05-28 |
| THERABOND ANTIMICROBIAL BARRIER SYSTEMS (K073213) | Choice Therapeutics | 2008-05-28 |
| PARIETEX PROGRIP MESH (K081050) | Sofradim Production | 2008-05-28 |
| VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET (K080934) | Nucletron Corporation | 2008-05-28 |
| VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION PROCESSES (K073244) | STERIS Corporation | 2008-05-28 |
| OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00 (K081203) | Philips Medizin Systeme Boeblingen GmbH | 2008-05-28 |
| WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H (K081256) | Rio Flexon Technology Co., Ltd. | 2008-05-27 |
| DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM (K081320) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-05-27 |
| CONCAVE RN HEALING CAP (K081186) | Institut Straumann AG | 2008-05-23 |
| ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC (K080869) | Beckman Coulter, Inc. | 2008-05-23 |
| TARRY MEDICAL TEMPERATURE PROBES (K071977) | Tarry Medical Products, Inc. | 2008-05-23 |
| SPINEASSIST SYSTEM (K073467) | Mazor Surgical Technologies , Ltd. | 2008-05-23 |
| DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID (K080618) | Jas Diagnostics, Inc. | 2008-05-23 |
| DEL SOL RED LIGHT THERAPY SYSTEM (K072399) | Edge Systems, Inc. | 2008-05-23 |
| ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106 (K080547) | Aesculap Implant System, Inc. | 2008-05-23 |
| DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691 (K081074) | Siemens Healthcare Diagnostics, Inc. | 2008-05-23 |
| LOCI THYROID CALIBRATOR WITH MODEL RC610 (K081103) | Siemens Healthcare Diagnostics, Inc. | 2008-05-23 |
| ARCOFIX (K080020) | Synthes Spine Co.Lp | 2008-05-23 |
| WATCH-PAT MODEL 100S-2 (K080427) | Itamar Medical | 2008-05-23 |
| ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 (K081154) | B-K Medical Aps | 2008-05-23 |
| ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES (K072859) | Internacional Farmaceutica, S.A. DE C.V. | 2008-05-23 |
| SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES (K080522) | Synthes (Usa) | 2008-05-23 |
| ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM (K072564) | Alma Lasers , Ltd. | 2008-05-23 |
| AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR (K081169) | Covidien Lp, Formerly Registered AS United States | 2008-05-23 |
| NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER (K080255) | Nonin Medical, Inc. | 2008-05-23 |
| CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER (K080631) | Oral Health Technologies, LLC | 2008-05-23 |
| ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES (K072863) | Internacional Farmaceutica, S.A. DE C.V. | 2008-05-23 |
| MROPEN (K073362) | Paramed S.R.L. | 2008-05-23 |
| POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE (K080937) | Gx Corporation Sdn Bhd | 2008-05-23 |
| SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM (K080321) | Snap Laboratories, LLC | 2008-05-23 |
| VAR MONITOR (K073261) | Vortran Medical Technology 1, Inc. | 2008-05-23 |
| NEMUS SYSTEM; NEMUS PC PERIPHERAL (K073415) | Eb Neuro S.P.A. | 2008-05-23 |
| URIC ACID (AOX), SCAL, NORTROL, ABTROL (K073612) | Thermofisher Scientific OY | 2008-05-23 |
| APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] (K080842) | Omni Life Science, Inc. | 2008-05-23 |
| MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS (K080257) | Medtronic Xomed, Inc. | 2008-05-22 |
| SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL (K073684) | Sheffield Industries, Div. of Faria , Ltd. | 2008-05-22 |
| KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT (K080159) | Kronus Market Development Associates, Inc. | 2008-05-22 |
| PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION (K081291) | Dentsply Interntional | 2008-05-22 |
| HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM (K081217) | Hycor Biomedical, Inc. | 2008-05-22 |
| SPACER-G TEMPORARY HIP PROSTHESIS (K062273) | Tecres S.P.A. | 2008-05-22 |
| SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321 (K062274) | Tecres S.P.A. | 2008-05-22 |
| DENTAL CERAMIC (K080479) | Dmg USA, Inc. | 2008-05-21 |
| SONOCA 180/195 WOUND CARE SYSTEM (K072904) | Soering GmbH | 2008-05-21 |
| CONQUEST SPINAL SYSTEM (K080767) | Life Spine | 2008-05-21 |
| MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS (K080598) | Intra-Lock International | 2008-05-21 |
| PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH (K081046) | Terumo Medical Corp. | 2008-05-21 |
| ECHELON GRAY CARTRIDGE, MODEL ERC45M (K080839) | Ethicon Endo-Surgery, LLC | 2008-05-21 |
| SMITH & NEPHEW INSTRUMENT TRAYS (K073551) | Smith & Nephew Inc., Endoscopy Div. | 2008-05-21 |
| NOVEL SPINAL SPACER SYSTEM (K080699) | Alphatec Spine, Inc. | 2008-05-21 |
| ELEXOMA MEDIC (K070412) | Redplane AG | 2008-05-21 |
| NEUTROPHASE (K081009) | Novabay Pharmaceuticals | 2008-05-20 |
| POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE (K081040) | Pt.Shamrock Manufacturing Corp. | 2008-05-20 |
| XTJF TYPE Q160VF1 (K080403) | Olympus Medical Systems Corporation | 2008-05-20 |
| CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX (K080946) | Conmed Endoscopic Technologies, Inc. | 2008-05-20 |
| OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) (K081281) | Nucletron Corporation | 2008-05-20 |
| INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES (K072600) | Sunlight Medical, Inc. | 2008-05-19 |