| C. DIFFICILE TOX A/B II (K003306) | Techlab, Inc. | 2000-11-22 |
| VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES, YELLOW (K003197) | Kaohsiung Brothers Products Corp. | 2000-11-22 |
| DERMAGRIP POWDER FREE PINK POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL W (K003307) | Wrp Specialty Products Sdn. Bhd. | 2000-11-22 |
| DERMAGRIP POWDER FREE GREEN POLYMER COATED EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE (K003309) | Wrp Specialty Products Sdn. Bhd. | 2000-11-22 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR (K003321) | Shanghai Antares Industries, Inc. | 2000-11-22 |
| RACE ENDODONTIC FILE (K002709) | Amc General, Inc. | 2000-11-17 |
| DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAM OR LESS OF TOTAL WA (K003132) | Wrp Specialty Products Sdn. Bhd. | 2000-11-17 |
| SSW-STERILE SOLUTION WARMER (K002859) | Kmi Kolster Methods, Inc. | 2000-11-16 |
| SURESMILE SYSTEM (K002620) | Orametrix, Inc. | 2000-11-16 |
| MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 (K002023) | Medmira Laboratories, Inc. | 2000-11-13 |
| PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI (K001177) | Enteric Products, Inc. | 2000-11-13 |
| FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) MADE FROM ALLO (K002720) | Tillotson Healthcare Corp. | 2000-11-09 |
| CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) (K002693) | Cbs Intl. B.V. | 2000-11-09 |
| CARESIDE CHOLINESTERASE (K002792) | Careside, Inc. | 2000-11-08 |
| MULTIPLE-VINYL EXAM GLOVE, POWDERED (K003133) | Excellence Ent. Co., Ltd. | 2000-11-07 |
| BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT (K003204) | Intracel Corp. | 2000-11-07 |
| PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE (K003019) | Wrp Asia Pacific Sdn. Bhd. | 2000-11-03 |
| RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE (K003233) | Riverstone Resources Sdn Bhd | 2000-11-03 |
| QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3 (K001249) | Consolidated Technologies of Wisconsin | 2000-11-02 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS (K003112) | Ortho-Clinical Diagnostics, Inc. | 2000-11-02 |
| CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 (K002556) | Pharmacia & Upjohn Co. | 2000-10-31 |
| RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE) (K003232) | Riverstone Resources Sdn Bhd | 2000-10-26 |
| OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER (K002982) | Olympus America, Inc. | 2000-10-25 |
| HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST (K003221) | Harald Nordin S.A | 2000-10-25 |
| HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST (K003219) | Harald Nordin S.A | 2000-10-25 |
| RAICHEM PHOSPORUS REAGENT (K003012) | Hemagen Diagnostics, Inc. | 2000-10-25 |
| DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 (K001493) | Air Force, Inc. | 2000-10-25 |
| MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW (K003091) | Medline Industries, Inc. | 2000-10-24 |
| DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STERILE, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL EXTRACTABL (K002975) | Wrp Specialty Products Sdn. Bhd. | 2000-10-24 |
| WHEELCHAIR, MECHANICAL SERIES MODEL 3100 (K002943) | Mada Medical Products, Inc. | 2000-10-23 |
| DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K000838) | P.T. Healthcare Glovindo | 2000-10-23 |
| DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K002814) | Shanghai PM Plastics Enterise Co., Ltd. | 2000-10-20 |
| VISIJET HYDROKERATOME, MODEL 50 (K991124) | Visijet, Inc. | 2000-10-20 |
| BACT/ALERT CSR (K003104) | Organon Teknika Corp. | 2000-10-20 |
| BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE) (K994276) | Biopro (M) Sdn Bhd | 2000-10-20 |
| BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE) (K994281) | Biopro (M) Sdn Bhd | 2000-10-20 |
| STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES (K002933) | Maxxim Medical | 2000-10-19 |
| PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES (K002849) | Surgical Specialties Corp | 2000-10-18 |
| MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM (K003090) | Midmark Corp. | 2000-10-18 |
| OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS) (K002922) | Omnigrace (Thailand) , Ltd. | 2000-10-16 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K002870) | Shanghai PT Plastics Enterprise Company, Ltd. | 2000-10-16 |
| INVERNESS MEDICAL OVULATION PREDICTOR TEST (K002867) | Selfcare, Inc. | 2000-10-12 |
| VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR (K002745) | Arista Latindo Industrial Ltd. P.T | 2000-10-12 |
| CARRIAZO BARRAQUER II MICROKERATOME (K002191) | Moria, Inc. | 2000-10-12 |
| EZ-COMFORT TRANSPORTER 2000 SERIES (K002673) | Jiangsu Intco Medical Equipment & Supply Co., Ltd. | 2000-10-11 |
| JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM (K002876) | Suiter Medical LLC | 2000-10-11 |
| EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIR (K002670) | Jiangsu Intco Medical Equipment & Supply Co., Ltd. | 2000-10-11 |
| EZ-LIGHT 4000 SERIES MANUAL WHEELCHAIR (K002669) | Jiangsu Intco Medical Equipment & Supply Co., Ltd. | 2000-10-11 |
| VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR (K002746) | Arista Latindo Industrial Ltd. P.T | 2000-10-11 |
| EZ-TRAVELER 2500 SERIES MANUAL WHEELCHAIR (K002671) | Jiangsu Intco Medical Equipment & Supply Co., Ltd. | 2000-10-11 |
| TDK HANDPIECES (K000848) | Orasystems | 2000-10-05 |
| VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 (K001460) | bioMerieux, Inc. | 2000-10-04 |
| GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING (K001125) | Geuder GmbH | 2000-10-04 |
| POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K002568) | Smart Glove Corp. Sdn Bhd | 2000-10-03 |
| BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 (K002294) | Biocheck, Inc. | 2000-10-02 |
| DISPOSABLE H-PE MICROKERATOME BLADES (K001464) | Oasis | 2000-10-02 |
| BRAVO PH MONITORING SYSTEM (K002028) | Endonetics, Inc. | 2000-09-29 |
| MODIFICATION TO: PRONTO DRY (K002451) | Medical Instruments Corporation, AG | 2000-09-29 |
| ORALUBE (K000847) | Orasystems | 2000-09-27 |
| BN PROSPEC SYSTEM (K001647) | Dade Behring, Inc. | 2000-09-26 |
| LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 (K002865) | Bio-Rad | 2000-09-25 |
| LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 (K002866) | Bio-Rad | 2000-09-25 |
| DISPOSABLE MICROKERATOME BLADES-PE (K001176) | Oasis Medical, Inc. | 2000-09-21 |
| BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS (K002540) | Bionostics, Inc. | 2000-09-18 |
| POWDER FREE LATEX EXAMINATION PATIENT GLOVES (K994420) | Purna Bina Sdn Bhd | 2000-09-18 |
| MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED (K000139) | Industrial Clothings, Ltd. | 2000-09-13 |
| BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS) (K002087) | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | 2000-09-13 |
| MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERFREE (K000138) | Industrial Clothings, Ltd. | 2000-09-13 |
| POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS) (K002701) | Alliance Rubber Products Sdn. Bhd. | 2000-09-13 |
| MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDERED (K000141) | Industrial Clothings, Ltd. | 2000-09-13 |
| PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS (K992476) | Pilling Weck Surgical | 2000-09-13 |
| MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED (K000143) | Industrial Clothings, Ltd. | 2000-09-13 |
| MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE (K000142) | Industrial Clothings, Ltd. | 2000-09-13 |
| MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE (K000145) | Industrial Clothings, Ltd. | 2000-09-13 |
| REFRACTIVE SURGERY BLADES (K001806) | Millennium Biomedical, Inc. | 2000-09-12 |
| LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM). (K002448) | Oon Corp. Resources | 2000-09-11 |
| RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI (K002111) | Perusahaan Pelindung Getah (M) Sdn Bhd | 2000-09-08 |
| DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS) (K002579) | Wrp Specialty Products Sdn. Bhd. | 2000-09-08 |
| OLEEVA FOAM (K002109) | Bio Med Sciences, Inc. | 2000-08-31 |
| LIQUICHEK LIPIDS CONTROL, MODEL 641, 642 (K002460) | Bio-Rad | 2000-08-31 |
| LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) (K002536) | Bio-Rad | 2000-08-30 |
| LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513 (K002535) | Bio-Rad | 2000-08-30 |
| MODEL 9000 BARIATRIC WHEELCHAIR (K002317) | Invacare Corp. | 2000-08-25 |
| KARMAN WHEELCHAIR (K002167) | Karman Healthcare, Inc. | 2000-08-25 |
| KARMAN WHEELCHAIR (K002202) | Karman Healthcare, Inc. | 2000-08-25 |
| PLAINSENSE WHEELCHAIR (K001909) | Plainsense Wheelchairs, Inc. | 2000-08-25 |
| CHROMOSTREAK (K000718) | Novamed , Ltd. | 2000-08-24 |
| CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY (K001943) | Sangui Biotech, Inc. | 2000-08-23 |
| VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW (K002340) | Glormed Intl., Inc. | 2000-08-22 |
| ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565 (K001935) | Beckman Coulter, Inc. | 2000-08-22 |
| PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR (K002065) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2000-08-22 |
| DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3 (K002174) | Casco-Nerl Diagnostics Corporation (Maine) | 2000-08-22 |
| LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573 (K002120) | Bio-Rad | 2000-08-21 |
| LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR (K002314) | Perusahaan Getah Asas Sdn. Bhd. | 2000-08-17 |
| NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUE (K002218) | Shanghai Champion Plastic Products Co., Ltd. | 2000-08-15 |
| NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE (K002220) | Shanghai Champion Plastic Products Co., Ltd. | 2000-08-15 |
| BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE (K000421) | Ssl Americas, Inc. (Regent Medical) | 2000-08-14 |
| RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED POWDER-FREE (K002112) | Perusahaan Pelindung Getah (M) Sdn Bhd | 2000-08-14 |
| URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING (K001810) | Flexsite Diagnostics, Inc. | 2000-08-14 |
| NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITE (K002217) | Shanghai Champion Plastic Products Co., Ltd. | 2000-08-11 |