| MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES (K040176) | Maxter Glove Manufacturing Sdn Bhd | 2004-02-24 |
| SIROAIR L AIR SCALER (K033812) | Sirona Dental Systems GmbH | 2004-02-23 |
| LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS (K040091) | Cliniqa Corporation | 2004-02-23 |
| INFRARED SCIENCES BREASTSCAN IR SYSTEM (K032350) | Infrared Sciences Corp. | 2004-02-20 |
| WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 (K023889) | Wiener Laboratories Saic | 2004-02-11 |
| CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS (K033213) | Codent Technical Industry Co., Ltd. | 2004-02-06 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO) (K034060) | Hong Huang Tang Industrial Co., Ltd. | 2004-02-06 |
| ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES (K033777) | Syntex Healthcare Products Co., Ltd. | 2004-02-05 |
| LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES) (K033924) | Bio-Rad Laboratories, Inc. | 2004-02-03 |
| AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 (K030849) | N-Dia, Inc. | 2004-02-02 |
| STV PRO 2 (K033419) | Trophy Radiologie | 2004-02-02 |
| PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD (K033182) | Surgin Surgical Instrumentation, Inc. | 2004-01-30 |
| PICCOLO MAGNESIUM TEST SYSTEM (K040115) | Abaxis, Inc. | 2004-01-30 |
| ESA PLASMA FREE METANEPHRINE ANALYSIS KIT (K032199) | Esa, Inc. | 2004-01-30 |
| ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES (K033532) | Asia Pacific Latex Sdn Bhd | 2004-01-28 |
| ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES (K033530) | Asia Pacific Latex Sdn Bhd | 2004-01-28 |
| HEEL SNUGGLER, MODEL 99047 (K040044) | Respironics, Inc. | 2004-01-27 |
| DUOPATH VEROTOXINS GLISA TEST (K031367) | Emd Chemicals, Inc. | 2004-01-23 |
| PERIO PROTECT TRAY (K031809) | Perio Protect, LLC | 2004-01-23 |
| CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM (K030876) | Cynosure, Inc. | 2004-01-22 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR (K033835) | Mdm Enterprise Corp. | 2004-01-22 |
| IDEIA PCE CHLAMYDIA (K033865) | Dakocytomation, Ltd. | 2004-01-21 |
| LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001 (K031321) | Medlogic Global Limited | 2004-01-21 |
| POWDER-FREE VINYL EXAMINATION GLOVES (K033693) | Shen Wei (Usa), Inc. | 2004-01-16 |
| LIGAND PLUS CONTROL LEVEL 1-3 (K033344) | Consolidated Technology | 2004-01-16 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR (K033877) | One Touch Products Co., Ltd. | 2004-01-16 |
| MODIFICATION TO SERAQUEST EB VCA IGG (K033915) | Quest Intl., Inc. | 2004-01-16 |
| POWDERED VINYL EXAMINATION GLOVES (K033692) | Shen Wei (Usa), Inc. | 2004-01-16 |
| MODIFICATION TO SERAQUEST VCA IGM (K033780) | Quest Intl., Inc. | 2004-01-15 |
| MED-LOGICS, MODEL ML7090 (K033293) | Med-Logics, Inc. | 2004-01-13 |
| SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR (K033683) | Smart Glove Corp. Sdn Bhd | 2004-01-08 |
| DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR (K033539) | Shen Wei (Usa), Inc. | 2004-01-08 |
| ELECSYS PRECICONTROL MULTIANALYTE (K033937) | Roche Diagnostics Corp. | 2004-01-07 |
| PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES (K033449) | Professional Dental Technologies Therapeutics, Inc. | 2004-01-07 |
| NOVA GLUCOSE CONTROL SOLUTIONS (K033433) | Nova Biomedical Corp. | 2004-01-02 |
| VINYL EXAMINATION GLOVES, POWDERED (K033308) | Tangshan Transocean Plastic Products Co., Ltd. | 2003-12-22 |
| B&R DEVICE (K032925) | Ronvig A/S | 2003-12-22 |
| BAYER CLINITEK STATUS ANALYZER (K031947) | Bayer Healthcare, LLC | 2003-12-19 |
| BAYER SPECIAL CHEMISTRY CONTROLS (K033379) | Bayer Diagnostics Corp. | 2003-12-19 |
| TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM (K031831) | Topcon Medical Systems, Inc. | 2003-12-19 |
| (MULTIPLE LABELS) POWDER-FREE VINYL EXAMINATION GLOVES (K033229) | Bernard Technologies, Inc. | 2003-12-17 |
| PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE (K032942) | Wrp Asia Pacific Sdn. Bhd. | 2003-12-17 |
| LIGHTCYCLER INSTRUMENT VERSION 1.2 (K033734) | Roche Diagnostics Corp. | 2003-12-17 |
| LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455 (K033366) | Bio-Rad | 2003-12-12 |
| MISSION CONTROLS (K033063) | Diamond Diagnostics, Inc. | 2003-12-12 |
| LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) (K033404) | Bio-Rad | 2003-12-12 |
| A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE (K032757) | A-Dec, Inc. | 2003-12-10 |
| IMMUNOCARDSTAT HPSA (K032222) | Meridian Bioscience, Inc. | 2003-12-05 |
| VPT METER (K030829) | Xilas Medical, Inc. | 2003-12-05 |
| HDL-CHOLESTEROL PLUS 2ND GENERATION (K033610) | Roche Diagnostics Corp. | 2003-12-05 |
| A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 (K032756) | A-Dec, Inc. | 2003-12-04 |
| A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT (K032572) | A-Dec, Inc. | 2003-12-03 |
| QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 (K033387) | Bio-Rad | 2003-12-02 |
| TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR (K033031) | Taiwan King Strong Co., Ltd. | 2003-12-02 |
| CHLAMYDIA IGG ELISA TEST SYSTEM (K033079) | Trinity Biotech USA | 2003-11-26 |
| PYLORI IGG (K033067) | Trinity Biotech USA | 2003-11-26 |
| ATR 5000, LC 5000, IMPLANT SYSTEM (K033597) | Advanced Technology Research (A.T.R.) S.R.L. | 2003-11-25 |
| MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM (K031997) | Mallinckrodt Dar S.R.L. | 2003-11-25 |
| OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH NOPAL & VITAMIN E (K023452) | Canopus Medical Supply Co., Ltd. | 2003-11-20 |
| BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE (K032940) | Brightway Holdings Sdn. Bhd. | 2003-11-20 |
| FUGUAN (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K032908) | Shijiazhuang Fuguan Plastic Products Co., Ltd. | 2003-11-20 |
| FUGUAN (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES (K032907) | Shijiazhuang Fuguan Plastic Products Co., Ltd. | 2003-11-20 |
| NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2) (K023537) | Sgmp Co., Ltd. | 2003-11-20 |
| BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER (K032938) | Brightway Holdings Sdn. Bhd. | 2003-11-20 |
| SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES (K032543) | Sirona Dental Systems GmbH | 2003-11-14 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA GREEN COLOR (K032670) | Kingswell International, Inc. | 2003-11-14 |
| NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY (K032444) | Cardinalhealth | 2003-11-13 |
| BLUE SAIL (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K032781) | Zibo Blue Sail Plastic & Rubber Products Co., Ltd. | 2003-11-13 |
| POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE BROTHERS (K031170) | Long First (Xiamen) Co., Ltd. | 2003-11-13 |
| BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES (K032783) | Zibo Blue Sail Plastic & Rubber Products Co., Ltd. | 2003-11-13 |
| Y.E.S. POWERED WHEELCHAIR, MODEL T200 (K032669) | Yeou Eir Shuen Machinery Co., Ltd. | 2003-11-12 |
| POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE (K030583) | Shen Wei (Usa), Inc. | 2003-11-10 |
| ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA (K032647) | Wrp Asia Pacific Sdn. Bhd. | 2003-11-07 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS (K032993) | Ortho-Clinical Diagnostics, Inc. | 2003-10-31 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS (K033127) | Ortho-Clinical Diagnostics | 2003-10-31 |
| MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS (K032731) | Turbo Wheelchair Co., Inc. | 2003-10-30 |
| FERTELL FEMALE FERTILITY TEST (K032002) | Genosis, Inc. | 2003-10-30 |
| MECHANICAL WHEEHCHAIR (K033141) | Pacific Medical Suppliers, Inc. | 2003-10-30 |
| DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A (K032798) | Dade Behring, Inc. | 2003-10-30 |
| HANDIVIPP (K033125) | Handinor USA, Inc. | 2003-10-30 |
| STERISIL ANTIMICROBIAL TUBING AND BOTTLE (K031681) | Sterisil | 2003-10-30 |
| POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR (K032084) | Shen Wei (Usa), Inc. | 2003-10-29 |
| POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K032024) | Shen Wei (Usa), Inc. | 2003-10-29 |
| SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE (K031750) | Kimberly-Clark Corp. | 2003-10-24 |
| POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED (K032374) | Perusahaan Getah Asas Sdn. Bhd. | 2003-10-22 |
| ROMED LATEX SURGICAL GLOVES, POWDERED, STERILE (K023139) | Van Oostveen Medical B.V. | 2003-10-22 |
| MEDI-HEAT INFANT HEEL WARMER (K032989) | Mediheat, Inc. | 2003-10-22 |
| BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 (K032166) | Binax, Inc. | 2003-10-21 |
| LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS (K032074) | Cliniqa Corporation | 2003-10-21 |
| MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME (K032978) | Ciba Vision Corporation | 2003-10-20 |
| GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM (K032819) | Bionostics, Inc. | 2003-10-20 |
| SHANGHAI GIANTMAX CLEAR VINYL POWDER FREE EXAMINATION GLOVES (K032746) | Shanghai Giantmax Plastic Product Corp. | 2003-10-17 |
| MICROGENICS CYCLOSPORINE CONTROL KIT (K032842) | Microgenics Corp. | 2003-10-17 |
| PROPHY-MATE (K032395) | Nakanishi, Inc. | 2003-10-17 |
| SHANGHAI GIANTMAX POWDERED CLEAR VINYL EXAMINATION GLOVES (K032745) | Shanghai Giantmax Plastic Product Corp. | 2003-10-17 |
| MAXTER STERILE POWDER FREE SURGICAL GLOVES (K032501) | Maxter Glove Manufacturing Sdn Bhd | 2003-10-17 |
| POWDER FREE LATEX EXAM GLOVES (K031335) | Tan Sin Lian Industries Sdn. Bhd. | 2003-10-16 |
| ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING (K031301) | Cardinalhealth | 2003-10-15 |
| PRE-POWDERED, NON-STERILE, VINYL EXAM GLOVES, YELLOW (K032792) | Shanghai Jiawang Industrial Co. , Ltd. | 2003-10-15 |
| ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 (K032904) | Dentsply Intl. | 2003-10-14 |