| ENPATH SAFETY INTRODUCER (K041708) | Enpath Medical Incorporated | 2004-11-30 |
| GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS (K041501) | Guangzhou Fortunique , Ltd. | 2004-11-30 |
| ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT (K041432) | Biofilm, Inc. | 2004-11-30 |
| FIBROTEK FIB (K042919) | R2 Diagnostics, Inc. | 2004-11-29 |
| TRIAGE D-DIMER TEST, MODEL 98100 (K042890) | Biosite Incorporated | 2004-11-29 |
| MB SYSTEM, BIOENERGY LIGHT THERAPY (K030275) | Amest Corp. | 2004-11-29 |
| POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL WATER, SOLUBLE VITAMIN E AND VITAMIN C AND PROTEIN LABELING (K042645) | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | 2004-11-26 |
| EZY-TRAVEL WRISTBAND (K041766) | Apothecary Products, Inc. | 2004-11-26 |
| MEDTRADE PRODICT'S SOOTHING GEL PATCH (K030901) | Medtrade Products , Ltd. | 2004-11-26 |
| CLEARFIL TRI-S BOND (K042913) | Kuraray Medical, Inc. | 2004-11-26 |
| REUSABLE FINGER CLIP SPO2 SENSORS (K042704) | Elekon Industries U.S.A., Inc. | 2004-11-26 |
| PACK & PROPER PACK & PROPER, EAR-THERMOMETER PROBE CAP (K042653) | Pack & Proper Co., Ltd. | 2004-11-26 |
| LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) (K042618) | La Glove (M) Sdn. Bhd. | 2004-11-26 |
| PRIMUS US (K042607) | Draeger Medical, Inc. | 2004-11-26 |
| NEXUS INTRAVENOUS TUBING SETS (NIVTS) (K041861) | Nexus Medical, LLC | 2004-11-26 |
| SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE (K042936) | Baxter Healthcare Corp | 2004-11-26 |
| TRIGEN HINDFOOT FUSION NAIL (K043052) | Smith & Nephew, Inc. | 2004-11-24 |
| GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO (K042960) | Given Imaging , Ltd. | 2004-11-24 |
| LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) (K042865) | Bio-Rad | 2004-11-24 |
| 15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER (K040328) | Medcomp | 2004-11-24 |
| ADSEAL ROOT CANAL SEALER (K042769) | Meta Biomed Co., Ltd. | 2004-11-24 |
| X-LEONARDO (K042995) | Siemens Medical Solutions USA, Inc. | 2004-11-24 |
| SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL (K042443) | Arkray, Inc. | 2004-11-24 |
| KASIOS TCP (K042340) | Kasios Biomaterials | 2004-11-24 |
| GUIDEWIRES (K042264) | Rocket Medical Plc | 2004-11-24 |
| COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE (K042996) | Volcano Therapeutics, Inc. | 2004-11-24 |
| THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS (K041427) | Arkray, Inc. | 2004-11-24 |
| MUCOTROL CONCENTRATED ORAL GEL WAFER (K042400) | Belcher Pharmaceuticals, Inc. | 2004-11-24 |
| FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 (K042043) | Fujinon, Inc. | 2004-11-24 |
| AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS (K042353) | National Display Systems | 2004-11-24 |
| IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE) (K041747) | Lifepoint,Inc | 2004-11-24 |
| GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM (K043112) | General Electric Co. | 2004-11-24 |
| DRY LASER IMAGER, MODEL DRYPRO MODEL 793 (K042133) | Konica Minolta Medical & Graphic, Inc. | 2004-11-24 |
| KOBRA GPS FIXATION SYSTEM (K042859) | Medtronic Vertelink, Inc. | 2004-11-24 |
| X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE (K042466) | Zest Anchors, Inc. | 2004-11-24 |
| ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE (K043175) | Roche Diagnostics Corp. | 2004-11-24 |
| NX STAGE WATER PURIFICATION SYSTEM (K042089) | Nxstage Medical, Inc. | 2004-11-24 |
| MCL 30 DERMABLATE ER:YAG LASER SYSTEM (K042968) | Asclepion Laser Technologies GmbH | 2004-11-24 |
| QUADRANT UNIT-1-BOND (K042806) | Cavex Holland BV | 2004-11-24 |
| COMMANDER II (K043096) | Cardiocom | 2004-11-24 |
| MODIFICATION TO SYNTHES CRANIAL PLATES (K042987) | Synthes (Usa) | 2004-11-23 |
| SMART BITEBLOC (K042665) | Oridion Medical 1987 , Ltd. | 2004-11-23 |
| THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM (K043082) | Signus Medizintechnik GmbH | 2004-11-23 |
| SILHOUETTE SPINAL FIXATION SYSTEM (K042702) | Zimmer Spine, Inc. | 2004-11-23 |
| RONDOFLEX PLUS 360 (K042872) | Kavo America Corporation | 2004-11-23 |
| BICONITE SURFACE TREATMENT (K031568) | Bicon, Inc. | 2004-11-23 |
| ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS (K042773) | Rostam , Ltd. | 2004-11-23 |
| SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT (K042883) | Howmedica Osteonics Corp. | 2004-11-23 |
| FLOWCARE SYSTEM (K041882) | Pointcare Technologies, Inc. | 2004-11-23 |
| UNI-THREAD SPINAL SYSTEM (K042640) | Spine Vision, Inc. | 2004-11-23 |
| IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) (K041746) | Lifepoint,Inc | 2004-11-23 |
| HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 (K041926) | Diagnostic Chemicals , Ltd. | 2004-11-23 |
| UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM (K042544) | Depuy Spine, Inc. | 2004-11-23 |
| ROCHE DIAGNOSTICS ELECSYS AFP CALSET II (K043095) | Roche Diagnostics Corp. | 2004-11-23 |
| COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1 (K041388) | Biomedical Life Systems, Inc. | 2004-11-23 |
| LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 (K041927) | Diagnostic Chemicals , Ltd. | 2004-11-23 |
| THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX (K043061) | Zimmer Trabecular | 2004-11-23 |
| TONO-PEN TONOMETER TIP COVER (K033146) | Tra & Accessories | 2004-11-23 |
| REPROCESSED DIAMOND BURS (K041978) | Alliance Medical Corp. | 2004-11-23 |
| HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B (K041928) | Diagnostic Chemicals , Ltd. | 2004-11-23 |
| RANDOX CANNABINOIDS ASSSAY (K041142) | Randox Laboratories, Ltd. | 2004-11-23 |
| FRC POSTEC PLUS (K042848) | Ivoclar Vivadent, Inc. | 2004-11-22 |
| S&C-SELF ETCH PR-BOND (K042614) | S & C Polymer GmbH | 2004-11-22 |
| MODIFICATION TO PROTEX STABILIZATION SYSTEM (K042953) | Globus Medical, Inc. | 2004-11-22 |
| PERFECTA FEMORAL STEM (K031402) | Wrightmedicaltechnologyinc | 2004-11-22 |
| PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 (K043138) | Atos Medical AB | 2004-11-22 |
| MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 (K042918) | Endooptiks, Inc. | 2004-11-22 |
| STATUS FIRST STREP A (K040708) | Princeton BioMeditech Corp. | 2004-11-22 |
| SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE (K042314) | Biogen | 2004-11-22 |
| BINDING SITE IGG SUBLCASS OLYMPUS KITS (K042152) | The Binding Site | 2004-11-22 |
| MX MONOAXIAL PEDICLE SCREW (K042964) | Scient'X | 2004-11-22 |
| MORTON IUI CATHETERS (K041470) | Fertility Technology Resources, Inc. | 2004-11-22 |
| VENTURE WIRE CONTROL CATHETER, MODEL WCC (K042910) | Velocimed, Inc. | 2004-11-22 |
| NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K042662) | Barco NV Barcoview | 2004-11-22 |
| MGP 15 DICOM THEATER (K042942) | Barco NV Barcoview | 2004-11-22 |
| BBLCHROMAGAR MRSA (K042812) | Becton, Dickinson & CO | 2004-11-22 |
| VIZILITE-BLUE ORAL EXAM KIT (K033033) | Trylon Corp. | 2004-11-22 |
| BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER (K042491) | Becton, Dickinson & CO | 2004-11-22 |
| CANDELA SMOOTHBEAM LASER SYSTEM (K041242) | Candela Corp. | 2004-11-22 |
| MEDICULT IVM SYSTEM (K041284) | Medicult A/S | 2004-11-22 |
| PET-DOSE (K042746) | Comecer S.R.L. | 2004-11-22 |
| AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE (K042897) | Ethicon Endo-Surgery, Inc. | 2004-11-19 |
| VENTURE ANTERIOR CERVICAL PLATING SYSTEM (K042922) | Medtronic Sofamor Danek, Inc. | 2004-11-19 |
| RHIGENE HEP-ANA TEST SYSTEM (K042680) | Corgenix, Inc. | 2004-11-19 |
| CAPNOSTAT 5 (K042601) | Respironics Novametrix, Inc. | 2004-11-19 |
| SECOND LOOK VIEWER (K042697) | Icad, Inc. | 2004-11-19 |
| COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM (K042473) | Cobe Cardiovascular, Inc. | 2004-11-19 |
| SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250 (K043025) | Analogic Corp. | 2004-11-19 |
| DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H (K042966) | Linvatec Biomaterials, Ltd. | 2004-11-19 |
| WEST NILE DETECT IGM ELISA (K041817) | Inbios Intl., Inc. | 2004-11-19 |
| INSTANT-VIEW TROPONIN I TEST (K042227) | Alfa Scientific Designs, Inc. | 2004-11-19 |
| AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101 (K042906) | Amplife Corporation | 2004-11-19 |
| NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K042660) | Barco NV Barcoview | 2004-11-19 |
| SMITH & NEPHEW MODULAR HIP (K042127) | Smith & Nephew, Inc. | 2004-11-19 |
| IMALUX NIRIS IMAGING SYSTEM (K042894) | Imalux Corporation | 2004-11-19 |
| ETEST FOR GEMIFLOXACIN (K042390) | Ab Biodisk | 2004-11-19 |
| MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD (K042347) | Dade Behring, Inc. | 2004-11-19 |
| VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN (K042477) | Ortho-Clinical Diagnostics, Inc. | 2004-11-19 |
| ARCHITECT CA 125 II ASSAY (K042731) | Fujirebio Diagnostics,Inc. | 2004-11-19 |
| 3VISEON (K043097) | 3Mensio Medical Imaging BV | 2004-11-19 |