| AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV (K043497) | J. Morita USA, Inc. | 2005-03-21 |
| RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 (K050125) | More Diagnostics | 2005-03-18 |
| AEU-14CF EXPENDITION (K050201) | Aseptico, Inc. | 2005-03-18 |
| POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL (K050527) | Spi Gloves Sdn. Bhd. | 2005-03-18 |
| POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE) (K050531) | Spi Gloves Sdn. Bhd. | 2005-03-18 |
| BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE (K050184) | Regent Medical Americas, LLC | 2005-03-16 |
| NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) (K050214) | Hartalega Sdn Bhd | 2005-03-16 |
| POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER (K050529) | Spi Gloves Sdn. Bhd. | 2005-03-16 |
| SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS (K042899) | Synthes (Usa) | 2005-03-16 |
| POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN) (K050530) | Spi Gloves Sdn. Bhd. | 2005-03-16 |
| STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER (K042169) | Stanbio Laboratory | 2005-03-14 |
| NITRILE POWDERED EXAMINATION GLOVES (WHITE) (K050215) | Hartalega Sdn Bhd | 2005-03-11 |
| VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE (K042952) | Zibo Hengchang Plastic & Rubber Products Co., Ltd. | 2005-03-10 |
| SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC (K043526) | Noble Fiber Technologies, Inc. | 2005-03-10 |
| PRE-POWDERED VINYL EXAM GLOVES (K042951) | Zibo Hengchang Plastic & Rubber Products Co., Ltd. | 2005-03-10 |
| POWDERED YELLOW SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE (K043478) | Shijaizhuang Brilliant Ocean Plastic Co., Ltd. | 2005-03-09 |
| BARI-KAD PACKING DEVICE (K050318) | Bioenvelop Agro, Inc. | 2005-03-04 |
| RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER (K050100) | Bionostics, Inc. | 2005-02-25 |
| MOMENTS MENOPAUSE CHECK, MODEL 9113 (K043599) | Phamatech, Inc. | 2005-02-25 |
| BIS SRS (SEMI-RESUABLE SENSOR) (K050313) | Aspect Medical Systems, Inc. | 2005-02-24 |
| QUADRANT RETRACTOR SYSTEM (K043602) | Medtronic Sofamor Danek | 2005-02-23 |
| DUREX PLAY WARMER LUBRICANT (K042563) | Ssl Americas, Inc. | 2005-02-23 |
| FERRIS POLYMEM STERILE BREAST PAD (K031660) | Ferris Mfg. Corp. | 2005-02-22 |
| MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE (K050191) | Becton, Dickinson & CO | 2005-02-22 |
| LERADO, COSCO (K050290) | Lerado Oversea Ltd. Twn Branch (Bvi) | 2005-02-18 |
| SPACELINE EMCIA, MODEL CU580 (K043496) | J. Morita USA, Inc. | 2005-02-16 |
| TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE (K043498) | J. Morita USA, Inc. | 2005-02-16 |
| PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 (K040958) | Tokyo Boeki Medical System , Ltd. | 2005-02-15 |
| RANDOX URINE CONTROLS (K043266) | Randox Laboratories, Ltd. | 2005-02-15 |
| MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS (K042659) | Medisiss | 2005-02-14 |
| ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES (K043325) | Rolence Enteprise, Inc. | 2005-02-11 |
| PROSTATE-63 CANCER DIAGNOSTIC TEST (K050063) | Asymmetrx | 2005-02-09 |
| ALCOHAWK PRECISION (K043188) | Q3 Innovations, LLC | 2005-02-09 |
| LIQUICHEK BNP CONTROL (K043584) | Bio-Rad Laboratories, Inc. | 2005-02-08 |
| PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE (K050152) | Dipped Products (Thailand), Ltd. | 2005-02-07 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K050154) | Zibo Zhuangyuan Plastic & Rubber Co., Ltd. | 2005-02-07 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K050155) | Zibo Zhuangyuan Plastic & Rubber Co., Ltd. | 2005-02-07 |
| POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE (K043499) | Shijaizhuang Brilliant Ocean Plastic Co., Ltd. | 2005-02-04 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K043475) | Shijiazhuang Winful Plastic Co., Ltd. | 2005-02-01 |
| AMADEUS II EPIKERATOME (K043150) | Sis Ltd., Surgical Instrument Systems | 2005-01-31 |
| POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVES WITH LABELING PROTEIN CONTENT CLAIM (50 MICROGRAMS OR LESS) (K043014) | Shijiazhuang Tillotson Rubber Products Co., Ltd. | 2005-01-28 |
| GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS (K043072) | Gen-Probe, Inc. | 2005-01-27 |
| LDL-EX SEIKEN ASSAY KIT (K043264) | Denka Seiken Co., Ltd. | 2005-01-26 |
| GC TION GINGIVAL PROTECTOR (K043301) | GC America, Inc. | 2005-01-25 |
| VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS (K042594) | Vanguard Medical Concepts, Inc. | 2005-01-25 |
| DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) (K043508) | Ansell Healthcare Products, LLC | 2005-01-19 |
| DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE (K043546) | Dade Behring, Inc. | 2005-01-18 |
| PANTHERA N POWDER FREE BLACK NITRILE GLOVES (K042898) | Glovco (M) Sdn. Bhd. | 2005-01-18 |
| NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING (K042879) | Sgmp Co., Ltd. | 2005-01-13 |
| POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE VERA AND VITAMIN E (K042567) | Pt. Medisafe Technologies | 2005-01-13 |
| ENDO TWINN (K042870) | Endo Twinn B.V. | 2005-01-11 |
| LIQUID ASSAYED MULTIQUAL CONTROL (K043208) | Bio-Rad | 2005-01-07 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K043477) | Shijiazhuang Winful Plastic Co., Ltd. | 2005-01-07 |
| SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM (K043310) | Synthes (Usa) | 2005-01-05 |
| CAPSULE TENSION RING INSERTER, MODEL 7-810 (K042478) | Duckworth & Kent, Ltd. | 2004-12-28 |
| TCM ENDO V, MODEL 1534 (K042822) | NOUVAG AG | 2004-12-22 |
| POWDER FREE CLEAR SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE (K043159) | Shijaizhuang Brilliant Ocean Plastic Co., Ltd. | 2004-12-20 |
| IS 40 MICROMOTOR (K042787) | Satelec | 2004-12-17 |
| MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II (K043320) | Roche Diagnostics Corp. | 2004-12-17 |
| FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE (K042239) | Pt. Mandiri Inti Buana | 2004-12-16 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE (K042805) | Perusahaan Getah Asas Sdn. Bhd. | 2004-12-16 |
| HELICOBACTER PYLORI IGG ELISA (K041238) | Biohit Plc | 2004-12-13 |
| WHEELCHAIR, MODEL 8500-II (K043332) | Cycling and Health Tech. Industry R&D Center | 2004-12-13 |
| IR VIEWER (K042679) | Infrared Imaging Systems, Inc. | 2004-12-10 |
| AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET (K042318) | Aalto Scientific, Ltd. | 2004-12-09 |
| LIQUID STABLE HBA1C CONTROL (K043070) | Canterbury Scientific , Ltd. | 2004-12-09 |
| ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL) (K042574) | Cardinalhealth | 2004-12-08 |
| COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM (K042970) | Copan Diagnostics, Inc. | 2004-12-07 |
| LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL (K043108) | Bio-Rad Laboratories, Inc. | 2004-12-07 |
| MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) (K042817) | Ansell Healthcare Products, Inc. | 2004-12-06 |
| OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 (K042828) | Young O/S, LLC | 2004-12-01 |
| POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE (K041913) | Pt. Medisafe Technologies | 2004-12-01 |
| 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 |
| MEDTRADE PRODICT'S SOOTHING GEL PATCH (K030901) | Medtrade Products , 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 |
| LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) (K042865) | Bio-Rad | 2004-11-24 |
| SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL (K042443) | Arkray, Inc. | 2004-11-24 |
| LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 (K041927) | Diagnostic Chemicals , Ltd. | 2004-11-23 |
| HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B (K041928) | Diagnostic Chemicals , Ltd. | 2004-11-23 |
| FRC POSTEC PLUS (K042848) | Ivoclar Vivadent, Inc. | 2004-11-22 |
| STATUS FIRST STREP A (K040708) | Princeton BioMeditech Corp. | 2004-11-22 |
| VIZILITE-BLUE ORAL EXAM KIT (K033033) | Trylon Corp. | 2004-11-22 |
| COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM (K042473) | Cobe Cardiovascular, Inc. | 2004-11-19 |
| QUIKREAD CRP CALIBRATOR SET (K042625) | Orion Diagnostica, OY | 2004-11-18 |
| POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES (K042830) | Grand Work Plastic Products Co., Ltd. | 2004-11-17 |
| MODIFICATION TO VISITOME 20-10 MICROKERATOME (K042083) | Biovision AG | 2004-11-16 |
| STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM (K042733) | Standard Imaging, Inc. | 2004-11-15 |
| XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B (K041951) | Remel, Inc. | 2004-11-15 |
| MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 (K041852) | Minrad, Inc. | 2004-11-15 |
| AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232 (K042171) | Micro-Mega Societe Anonyme | 2004-11-10 |
| SURGICHIP TAG SURGICAL MARKER (K042555) | Surgichip, Inc. | 2004-11-09 |
| SOUTH BEACH SMILE LIGHT WHITENING SYSTEM (K042153) | Dentovations, Inc. | 2004-11-08 |
| SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US (K041392) | CAO Group, Inc. | 2004-11-08 |
| QUEST TUMOR MARKER CONTROL, MODEL 955 (K042815) | Bio-Rad | 2004-11-05 |
| MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL (K042717) | Medical Analysis Systems, Inc. | 2004-11-05 |
| TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR (K042652) | Taiwan King Strong Co., Ltd. | 2004-11-04 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES (K042120) | Shijiazhuang Manful Light Industrial Products Co., | 2004-11-04 |
| POWDER-FREE VINYL PATIENT EXAMINTION GLOVES (K042119) | Shijiazhuang Manful Light Industrial Products Co., | 2004-11-03 |
| LIQUICHEK ELEVATED CRP CONTROL (K042837) | Bio-Rad | 2004-11-02 |
| QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS (K042446) | Bio-Rad Laboratories, Inc. | 2004-11-02 |