| FLO-BOOT (K003272) | Discovery Group, LLC | 2001-04-04 |
| POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE (K010110) | Shen Wei (Usa), Inc. | 2001-04-03 |
| LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE) (K010861) | La Glove (M) Sdn. Bhd. | 2001-04-03 |
| LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE) (K010860) | La Glove (M) Sdn. Bhd. | 2001-04-03 |
| POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K010097) | Shen Wei (Usa), Inc. | 2001-03-30 |
| ELISA TEST, SEROLOGY (K003794) | Micro Detect, Inc. | 2001-03-30 |
| POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE (K010663) | Tong Ruhn Medical Products Co., Ltd. | 2001-03-30 |
| NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES (K004031) | Dental Power, Inc. | 2001-03-28 |
| LATEX EXAMINATION GLOVES-POWDER FREE (K010356) | Enzymic Technologies Sdn Bhd | 2001-03-27 |
| LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE (K010347) | Enzymic Technologies Sdn Bhd | 2001-03-27 |
| JAS MAGNESIUM REAGENT (K003835) | Jas Diagnostics, Inc. | 2001-03-23 |
| RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER (K010052) | Respironics, Inc. | 2001-03-19 |
| MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD (K003979) | Medtrade Products , Ltd. | 2001-03-19 |
| MRI SAFE INSTRUMENTS (K003965) | Aesculap, Inc. | 2001-03-16 |
| SPECULITE/ORALLITE (K003995) | Trylon Corp. | 2001-03-16 |
| WISEBANDS SKIN CLOSURE DEVICE (K002315) | Wisebands , Ltd. | 2001-03-15 |
| MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (K010523) | Binax, Inc. | 2001-03-15 |
| ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349 (K010428) | Beckman Coulter, Inc. | 2001-03-13 |
| OPD-SCAN, MODELS ARK-10000 AND ARK-9000 (K003299) | Nidek Co., Ltd. | 2001-03-09 |
| CARRIAZO BARRAQUER SINGLE USE MICROKERATOME (K003594) | Moria, Inc. | 2001-03-09 |
| DISPOSABLE CB-PE MICROKERATOME BLADES (K003820) | Oasis Medical, Inc. | 2001-03-08 |
| VIGIL SEROLOGY CONTROL LEVEL C (K010358) | Beckman Coulter, Inc. | 2001-03-05 |
| HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES (K010077) | Pwa Industries Sdn. Bhd. | 2001-02-28 |
| CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK (K010111) | Medical Analysis Systems, Inc. | 2001-02-28 |
| STERILE POWDERED LATEX SURGEON GLOVES (K010198) | Supermax Glove Manufacturing Sdn Bhd | 2001-02-23 |
| MEDLOGICS ML 4000, MODEL 4000 (K002515) | Med-Logics, Inc. | 2001-02-22 |
| PHOSPHORUS REAGENT (K003912) | Jas Diagnostics, Inc. | 2001-02-21 |
| MEDITHERM MED2000 (K003332) | Meditherm, Inc. | 2001-02-21 |
| REGUTHERM 952 THERMOGRAPHIC SYSTEM (K003130) | Sie-Med, Inc. | 2001-02-16 |
| SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE) (K010297) | Maxxim Medical | 2001-02-16 |
| COMFOR-CLINER (K010194) | Recliner Care, Inc. | 2001-02-15 |
| STERILE NITRILE POWDER-FREE EXAMINATION GLOVES (K010211) | Allegiance Healthcare Corp. | 2001-02-15 |
| NITRILE EXAMINATION GLOVES (POWERED) (K003922) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-02-15 |
| A & I WHEELCHAIRS (K010094) | Taiwan an I Co., Ltd. | 2001-02-15 |
| ELECSYS HCG+B CALCHECK (K010237) | Roche Diagnostics Corp. | 2001-02-14 |
| POWDERFREE NITRILE PATIENT EXMINATION GLOVE (K003985) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-02-09 |
| JK GLOVES PRE-POWDERED LATEX EXAMINATION GLOVE (K010231) | Jk Gloves Sdn. Bhd. | 2001-02-09 |
| NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH & WITHOUT GRAPE SCENT WITH PROTEIN LABELING (200 MICROGRAMS OR (K010095) | Sgmp Co., Ltd. | 2001-02-09 |
| ENVIVE MINIFORMS (K003843) | Procter & Gamble Co. | 2001-02-08 |
| IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) (K002469) | W&H Dentalwerk Buermoos GmbH | 2001-02-07 |
| SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K004048) | Tillotson Healthcare Corp. | 2001-02-06 |
| SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES (K010247) | Shanghai China Star Corp | 2001-02-06 |
| MODIFICATION TO CAVERMAP SURGICAL AID (K010098) | Uromed Corp. | 2001-02-01 |
| POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS) (K003737) | Perusahaan Getah Asas Sdn. Bhd. | 2001-02-01 |
| EPI-DERM SILICONE GEL SHEETING (K003948) | Biodermis Corp. | 2001-01-29 |
| LIQUIDERM LIQUID ADHESIVE BANDAGE (K002338) | Closure Medical Corp. | 2001-01-29 |
| GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE) (K010078) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-01-29 |
| POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K003934) | Seltom Pacific Sdn. Bhd. | 2001-01-26 |
| FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM A (K002719) | Tillotson Healthcare Corp. | 2001-01-26 |
| STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) (K003653) | Wrp Asia Pacific Sdn. Bhd. | 2001-01-26 |
| GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K010054) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-01-26 |
| MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K003055) | Medline Industries, Inc. | 2001-01-26 |
| POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE (K010072) | Wrp Asia Pacific Sdn. Bhd. | 2001-01-26 |
| POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES (K003904) | Purna Bina Sdn Bhd | 2001-01-24 |
| KENDALL-LTP TURNER SAVE-A-LINE (K003511) | The Ludlow Company LP | 2001-01-24 |
| GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K003872) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-01-23 |
| BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY (K000884) | Becton Dickinson Biosciences | 2001-01-19 |
| ELECSYS DHEA-S (K003174) | Roche Diagnostics Corp. | 2001-01-17 |
| X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21 (K003895) | Ansell Perry | 2001-01-17 |
| ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K003771) | Ansell Healthcare Products, Inc. | 2001-01-16 |
| CA 125 II CALCHECK (K003967) | Roche Diagnostics Corp. | 2001-01-12 |
| MADA WHEELCHAIRS (K003862) | Mada Medical Products, Inc. | 2001-01-12 |
| PORTABLE BREAST COMPRESSION DEVICE (K003775) | Pem Technologies | 2001-01-12 |
| MEDICAL DEPOT-WHEELCHAIRS, MODEL SENTRA,ASTAIRE AND VIPER (K003783) | Medical Depot, Inc. | 2001-01-12 |
| GENUA MENOPAUSE MONITOR TEST KIT (K002450) | Genua 1944, Inc. | 2001-01-12 |
| RAPIDD HIGHSPEED DENTAL HANDPIECE (K003518) | Dentsply Intl. | 2001-01-09 |
| SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMINATION GLOVES (K003675) | Shanghai China Star Corp | 2001-01-09 |
| MONARCH II IOL DELIVERY SYSTEM (K003768) | Alcon Research, Ltd. | 2001-01-05 |
| KELO-COTE TOPICAL GEL (K002488) | Advanced Bio-Technologies, Inc. | 2001-01-05 |
| POWDER-FREE NITRILE EXAM GLOVE, LAVENDER/PURPLE (K003563) | Ning BO Yujiang Rubber & Plastic Co. | 2001-01-02 |
| ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87 (K003769) | Ansell Healthcare Products, Inc. | 2000-12-22 |
| SYNCHRON SYSTEMS AMMONIA REAGENT (K003196) | Beckman Coulter, Inc. | 2000-12-22 |
| TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 (K003036) | Retinalabs.Com | 2000-12-22 |
| CLEANAIR/ CLEANWATER UNIT, MODEL 1600 (K003265) | Texas Institute For Conservative Dentistry | 2000-12-22 |
| NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) (K003547) | Terang Nusa Sdn Bhd | 2000-12-21 |
| NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE (K003545) | Terang Nusa Sdn Bhd | 2000-12-21 |
| CONFORMANCE CHEMISTRY CONTROL C3 (K003716) | Consolidated Technology | 2000-12-20 |
| RDH BANDAGE (K002550) | Marine Polymer Technologies, Inc. | 2000-12-20 |
| ELECSYS DHEA-S CALCHECK (K003772) | Roche Diagnostics Corp. | 2000-12-20 |
| MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER (K003721) | Olympus America, Inc. | 2000-12-18 |
| ALL TERRAIN WHEELCHAIR (ATW) (K003048) | Roll-Ability (Pty) , Ltd. | 2000-12-15 |
| CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO (K000834) | Castellini S.P.A. | 2000-12-14 |
| PROCLUDE (K002989) | Ortek Therapeutics, Inc. | 2000-12-14 |
| MILLENNIUM BLADES, MODEL MB101 (K003143) | Millennium Biomedical, Inc. | 2000-12-11 |
| ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 (K002128) | Diagnostic Systems Laboratories, Inc. | 2000-12-05 |
| NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS) (K002391) | Siam Sempermed Corp., Ltd. | 2000-12-04 |
| LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 (K003242) | Bio-Rad | 2000-11-30 |
| LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 (K003239) | Bio-Rad | 2000-11-30 |
| NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR) POWDERED, NON STERILE (K002819) | Siam Sempermed Corp., Ltd. | 2000-11-29 |
| POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM (K002593) | Hartalega Sdn Bhd | 2000-11-29 |
| ALMATEX POWDER-FREE LATEX EXANINATION GLOVES WITH PROTIEN LABELING CLAIM 50 MICROGRAMS OR LESS (K003213) | Concept Rubber Products Sdn Bhd | 2000-11-29 |
| FASTPACK CONTROL (K003095) | Qualigen, Inc. | 2000-11-29 |
| NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE (K002818) | Siam Sempermed Corp., Ltd. | 2000-11-29 |
| COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL (K002064) | Wrp Asia Pacific Sdn. Bhd. | 2000-11-28 |
| SYNCHRON CONTROL (K003488) | Beckman Coulter, Inc. | 2000-11-27 |
| N/T PROTEIN CONTROL SL (K002852) | Dade Behring, Inc. | 2000-11-27 |
| GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION (K003063) | Gimbel Glove Co., LLC | 2000-11-22 |
| COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K001613) | Wrp Asia Pacific Sdn. Bhd. | 2000-11-22 |
| MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA (K003353) | Medline Industries, Inc. | 2000-11-22 |
| BIO-RAD %CDT TIA (K001651) | Axis-Shield Biochemicals, Asa | 2000-11-22 |