| BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS (K000056) | Biocell Laboratories, Inc. | 2000-02-24 |
| MERETEK UBT_LITE BREATH TEST FOR H. PYLORI (K000316) | Meretek | 2000-02-24 |
| SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES (K000166) | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 2000-02-22 |
| ACTION AF-1 WHEELCHAIR (K000174) | Invacare Corp. | 2000-02-18 |
| SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES (K000156) | Shield Gloves Manufacturer (M) Sdn Bhd | 2000-02-18 |
| ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W (K000217) | Shield Gloves Manufacturer (M) Sdn Bhd | 2000-02-18 |
| PERCUGUARD (K992539) | Digit-Pro | 2000-02-18 |
| ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K000295) | Ansell Perry | 2000-02-16 |
| HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS) (K994432) | Hwa Teh Industrial Sdn. Bhd. | 2000-02-16 |
| 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM (K992662) | Bayer Corp. | 2000-02-15 |
| QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3 (K000116) | Consolidated Technologies, Inc. | 2000-02-15 |
| CAVERMAP SURGICAL AID (K993436) | Uromed Corp. | 2000-02-11 |
| ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS) (K993190) | Surgical Instrument Systems (Sis), Ltd. | 2000-02-10 |
| HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION (K993918) | Pamitex Industries Sdn Bhd | 2000-02-10 |
| BACT/ALERT SV (K994343) | Organon Teknika Corp. | 2000-02-10 |
| YEASTEST (K993554) | Diagnostic Markers, Inc. | 2000-02-10 |
| GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES (K000090) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2000-02-10 |
| X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 (K000052) | Dynarad Corp. | 2000-02-10 |
| SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW (K992979) | Shanghai Poseidon Plastic Products Co., Ltd. | 2000-02-09 |
| POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (75 MICROGRAMS OR LESS) (K994162) | Allegiance Healthcare Corp. | 2000-02-09 |
| AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GREEN AND PINK), WITH PROTEIN CONTENT LABELING CLAIM (50 MI (K993912) | Latexx Partners, Inc. | 2000-02-09 |
| FRONTAL SINUS TREPHINATION CANNULA (K994262) | Xomed, Inc. | 2000-02-08 |
| TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K994250) | Tekmedic (M) Sdn Bhd | 2000-02-07 |
| AMBIDERM POWDERFREE LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM OF 50 MICROGRAMS OR LESS PER GRAM (BLACK COLORED) (K994131) | Medtaxx Partners | 2000-02-07 |
| SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR (K994222) | Shijiazhuang Hongray Plastic Products Co., Ltd. | 2000-02-07 |
| POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (K993876) | Shen Wei (Usa), Inc. | 2000-02-07 |
| SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR (K994206) | Shijiazhuang Hongray Plastic Products Co., Ltd. | 2000-02-07 |
| LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE (K994255) | Pt. Maja Agung Latexindo | 2000-02-07 |
| RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K994201) | Perusahaan Pelindung Getah (M) Sdn Bhd | 2000-02-07 |
| BILICHEK NON-INVASIVE BILIRUBIN ANALYZER (K994438) | Spectrx, Inc. | 2000-02-04 |
| POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES (K994136) | Shanghai Champion Plastic Products Co., Ltd. | 2000-02-03 |
| EXTENDED STRAIGHT ATTACHMENT (K994024) | Team Technologies, Inc. | 2000-02-03 |
| PRO-TORQ (K000120) | Micro Motors, Inc. | 2000-02-03 |
| POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K994416) | Flexitech Sdn. Bhd. | 2000-02-03 |
| IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 (K994035) | Diagnostic Chemicals , Ltd. | 2000-02-01 |
| 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM (K994148) | Implant Innovations, Inc. | 2000-02-01 |
| ROTARY MASTER (K992648) | J. Morita USA, Inc. | 2000-01-31 |
| KERLIX MD ANTIMICROBIAL GAUZE DRESSING (K990530) | The Kendall Company, L.P. | 2000-01-31 |
| OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED (K994246) | Omnigrace , Ltd. | 2000-01-31 |
| THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR (K993857) | Ansell Perry | 2000-01-31 |
| ULTRASHAPER KERATOME (K990227) | Lasersight Technologies, Inc. | 2000-01-31 |
| POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K994354) | Flexitech Sdn. Bhd. | 2000-01-31 |
| TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE (K994115) | Dade Behring, Inc. | 2000-01-28 |
| BLUE NITRILE EXAMINATION GLOVES - POWDER FREE (K994064) | Glove Source, Inc. | 2000-01-28 |
| POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS) (K994082) | Besglove Medicare Sdn. Bhd. | 2000-01-28 |
| SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES (K994248) | Shinemound Enterprise, Inc. | 2000-01-28 |
| COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES (K993864) | Supermax Sdn Bhd | 2000-01-20 |
| PATIENT NITRILE EXAMINATION GLOVES (POWDERED) (K992675) | Wear Safe Malaysia Sdn. Bhd. | 2000-01-20 |
| GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES (K993865) | Supermax Sdn Bhd | 2000-01-20 |
| POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) (K994013) | Glovco (M) Sdn. Bhd. | 2000-01-20 |
| SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES (K994258) | Shinemound Enterprise, Inc. | 2000-01-20 |
| TEH LOONG VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVE (K993849) | Longbest (Xiamen) Balls Co., Ltd. | 2000-01-18 |
| ACCESS HYBRITECH PSA QC, MODEL 37209 (K994200) | Beckman Coulter, Inc. | 2000-01-18 |
| UNSCENTED INTERLABIAL MENSTRUAL PAD (K993870) | Procter & Gamble Co. | 2000-01-18 |
| LUMAGEM SCINTILLATION CAMERA (K993813) | Gamma Medica | 2000-01-18 |
| SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES (K994081) | Safeskin Corp. | 2000-01-18 |
| TEH LOONG, VINYL, POWDERED, PATIENT EXAMINATION GLOVES (K993847) | Longbest (Xiamen) Balls Co., Ltd. | 2000-01-18 |
| LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR (K990445) | Lpg USA, Inc. | 2000-01-18 |
| OSOM ULTRA STREP A TEST, MODEL 147 (K992658) | Wyntek Diagnostics, Inc. | 2000-01-18 |
| ACCESS OSTASE QC (K994277) | Beckman Coulter, Inc. | 2000-01-14 |
| MANUAL WHEELCHAIR (K994185) | Major Mobility Products, Inc. | 2000-01-13 |
| MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) (K993377) | Polymer Technology Systems, Inc. | 2000-01-13 |
| SIGMA MANUAL WHEELCHAIR (K993963) | Sigma Distribution & Supply, Inc. | 2000-01-13 |
| GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE (K993793) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2000-01-12 |
| INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS] (K993567) | Innovative Gloves Co;, Ltd. | 2000-01-12 |
| SHANGHAI GLOVMAX ENTERPRISE CO., LTD. PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES (K993859) | Shanghai Glovmax Enterprise Co.,Ltd | 2000-01-12 |
| SHANGHAI GLOVMAX ENTERPRISE CO, LTD., POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K993880) | Shanghai Glovmax Enterprise Co.,Ltd | 2000-01-12 |
| CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES (K994043) | Biopro (M) Sdn Bhd | 2000-01-11 |
| SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES (K993664) | Top Glove Sdn. Bhd. | 2000-01-11 |
| DENTAL HANDPIECE (K971732) | Pauline M. Nicholls | 2000-01-11 |
| SYNEA - LS LOW-SPEED HANDPIECE (K993526) | A-Dec, Inc. | 2000-01-11 |
| ACCESS HYBRITECH FREE PSA QC, MODEL 37219 (K993210) | Beckman Coulter, Inc. | 2000-01-05 |
| URINALYSIS REAGENT STRIPS (10 PARAMETERS) (K993850) | International Newtech Development, Inc. | 2000-01-03 |
| LATEX SURGICAL GLOVES, PRE-POWDERED (K993450) | Fitco Dipped Products Pvt., Ltd. | 1999-12-29 |
| HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC (K993621) | Pamitex Industries Sdn Bhd | 1999-12-29 |
| POWDER FREE LATEX STERILE SURGICAL GLOVES (K993562) | Tg Medical Sdn. Bhd. | 1999-12-29 |
| POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K993529) | Biografik (Malaysia) Sdn Bhd | 1999-12-29 |
| BLADEWORKS DISPOSABLE ALK TUBING (K993591) | Blade Works, Inc. | 1999-12-28 |
| MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 (K983860) | Polymer Technology Systems, Inc. | 1999-12-27 |
| OMNICORDER BIOSCAN SYSTEM (K990416) | Omnicorder Technologies, Inc. | 1999-12-23 |
| EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM (K992587) | Stellar Bio Systems, Inc. | 1999-12-22 |
| SPACE-OR RETRACTOR (K993544) | Advanced Surgical Concepts (Asc) | 1999-12-22 |
| UNI-GOLD H. PYLORI (K991697) | Trinity Biotech, Plc | 1999-12-21 |
| CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K (K993812) | Hardy Diagnostics | 1999-12-21 |
| AXIS %CDT TURBIDIMETRIC IMMUNOASSAY (K992502) | Axis | 1999-12-21 |
| TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION (K981915) | The Binding Site, Ltd. | 1999-12-20 |
| PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES (K993605) | Top Glove Sdn. Bhd. | 1999-12-20 |
| PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR (K993096) | Lifestream Technologies, Inc. | 1999-12-20 |
| LATEX EXAMINATION POWDERED GLOVES (K993386) | Great Glove Sdn Bhd | 1999-12-20 |
| GREEN POWDERED LATEX EXAMINATION GLOVES (K993452) | Top Glove Sdn. Bhd. | 1999-12-20 |
| INTERFACE MODULE IDDD (K992635) | Stoeckert Instrumente | 1999-12-20 |
| PRE-POWDERED VINYL EXAM GLOVE, NON STERILE (K994036) | Shanghai Champion Plastic Products Co., Ltd. | 1999-12-20 |
| PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES (K992676) | Wear Safe Malaysia Sdn. Bhd. | 1999-12-16 |
| PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE (K992681) | Wear Safe Malaysia Sdn. Bhd. | 1999-12-16 |
| ATR 3000, ATR 2000, IMPLANT-PRO (K991401) | Advanced Technology Research (A.T.R.) S.R.P. | 1999-12-15 |
| BACT/ALERT SA (K993423) | Organon Teknika Corp. | 1999-12-15 |
| BACT/ALERT SN (K993421) | Organon Teknika Corp. | 1999-12-14 |
| BACT/ALERT MP PROCESS BOTTLE (K993576) | Organon Teknika Corp. | 1999-12-14 |
| SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE (K993680) | Top Glove Sdn. Bhd. | 1999-12-13 |
| PREMIER TOXINS A&B, MODEL 616096 (K993914) | Meridian Diagnostics, Inc. | 1999-12-10 |