| BIOSCANNER PLUS; LIPID PANEL TEST STRIPS (K013173) | Polymer Technology Systems, Inc. | 2001-10-22 |
| TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE (K013016) | Tillotson Healthcare Corp. | 2001-10-19 |
| POWERPRO BATTERY SYSTEM (K012320) | Linvatec Corp. | 2001-10-19 |
| N LP(A) CONTROL SY (K013130) | Dade Behring, Inc. | 2001-10-18 |
| ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES (K012499) | Shanghai Antares Industries, Inc. | 2001-10-16 |
| ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW (K012339) | Shanghai Antares Industries, Inc. | 2001-10-16 |
| MODIFICATION TO SYNCHRON CONTROL (K013235) | Beckman Coulter, Inc. | 2001-10-16 |
| POWDERED LATEX EXAMINATION GLOVES (K013026) | Great Glove (Thailand) Co. , Ltd. | 2001-10-15 |
| CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERA (K013286) | Tillotson Healthcare Corp. | 2001-10-12 |
| OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM (K012402) | Omnigrace (Thailand) , Ltd. | 2001-10-12 |
| SNOWPOST, SNOWLIGHT (K012354) | Danville Materials, Inc. | 2001-10-10 |
| PHEM-ALERT (K012230) | Femtek,Llc. | 2001-10-09 |
| ALWAYS DUETS (K012629) | Procter & Gamble Co. | 2001-10-05 |
| W & H ASSISTINA (K010127) | A-Dec, Inc. | 2001-10-05 |
| SOPRO595 INTRA ORAL CAMERA (K012505) | Sopro | 2001-10-05 |
| DISPOSABLE POWDERED VINYL EXAMINATION GLOVES (K012710) | Shijiazhuang Brilliance Plastic Co., Ltd. | 2001-10-04 |
| TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001 (K012999) | Biosite Incorporated | 2001-10-03 |
| TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 (K013002) | Biosite Incorporated | 2001-10-03 |
| ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 (K012435) | Bausch & Lomb, Inc. | 2001-10-02 |
| SONICWAVE SONIC PLAQUE REMOVER (K012914) | Homedics, Inc. | 2001-10-01 |
| DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K012876) | Wrp Specialty Products Sdn. Bhd. | 2001-10-01 |
| POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (GREEN) (K012709) | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | 2001-10-01 |
| BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) (K012340) | Bayer Corp. | 2001-10-01 |
| POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE) (K012786) | Shamrock Manufacturing Company | 2001-10-01 |
| LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL (K012907) | Clinical Controls | 2001-09-28 |
| BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM (K011970) | Biosafe Laboratories, Inc. | 2001-09-26 |
| POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5 (K011961) | Shen Wei (Usa), Inc. | 2001-09-26 |
| THE INTUITIVE COLORIMETER (K012298) | Cerium Optical Technologies, Inc. | 2001-09-26 |
| STERILE NITRILE SURGICAL GLOVES (POWDERED) (K012479) | Smart Glove Corp. Sdn Bhd | 2001-09-26 |
| HP-ONE (K012411) | Gi Supply | 2001-09-25 |
| MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 (K010891) | Digene Corp. | 2001-09-25 |
| MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 (K010892) | Digene Corp. | 2001-09-24 |
| POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN, CHEMOTHERAPY LABELING CLAIM (K012149) | Allegiance Healthcare Corp. | 2001-09-24 |
| NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K012863) | Sgmp Co., Ltd. | 2001-09-21 |
| NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH BLUEBERRY SCENTED AND PROTEIN CONTENT CLAIM (50 MICROGRAMS O (K012857) | Sgmp Co., Ltd. | 2001-09-21 |
| PRE-POWDERED NITRILE EXAMINATION GLOVES (K010232) | P.T. Healthcare Glovindo | 2001-09-21 |
| POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEIN LABELING CLAIM (<50UG/G) (K012860) | Sgmp Co., Ltd. | 2001-09-21 |
| GSA GENITO SENSORY ANALYZER (K010981) | Medoc Ltd. Advanced Medical Systems | 2001-09-20 |
| GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE (K012899) | Best Manufacturing Company | 2001-09-18 |
| DISPOSABLE POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K012711) | Shijiazhuang Brilliance Plastic Co., Ltd. | 2001-09-18 |
| CLINCARE LATEX SURGEON'S GLOVE (K012067) | Ttk Healthcare , Ltd. | 2001-09-17 |
| POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE (K011613) | Shield Gloves Manufacturer (M) Sdn Bhd | 2001-09-17 |
| POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS (K012558) | Matang Mfg. Sdn. Bhd. | 2001-09-17 |
| COLORMATE TLC BILITEST SYSTEM (K001687) | Chromatics Color Sciences Intl., Inc. | 2001-09-13 |
| LIQUICHEK TDM CONTROL (K012741) | Bio-Rad | 2001-09-12 |
| TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM (K011045) | Shen Wei (Usa), Inc. | 2001-09-11 |
| STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) (K011066) | Smart Glove Corp. Sdn Bhd | 2001-09-11 |
| LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO (K011407) | Sempermed USA, Inc. | 2001-09-11 |
| ELEC-MATE E (K011926) | Nakanishi, Inc. | 2001-09-11 |
| TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER (K011044) | Shen Wei (Usa), Inc. | 2001-09-10 |
| LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 (K012656) | Bio-Rad | 2001-09-06 |
| MHS 5000 (K011981) | Micro Health Systems, Inc. | 2001-09-05 |
| BRITESMILE BARRIER MATERIAL (K010935) | Britesmile, Inc. | 2001-09-05 |
| MODIFICATION TO N/T PROTEIN CONTROL SL (K012468) | Dade Behring, Inc. | 2001-09-04 |
| AA-1 SYSTEM (K012530) | Neurovision, Inc. | 2001-08-31 |
| LIQUISPX LIQUID LIPID CONTROL (K012855) | Clinical Controls Division | 2001-08-30 |
| VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 (K012593) | Ortho-Clinical Diagnostics, Inc. | 2001-08-30 |
| JET THERAPY (K002908) | Jet Therapy | 2001-08-30 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS (K012561) | Ortho-Clinical Diagnostics | 2001-08-29 |
| LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642 (K012513) | Bio-Rad | 2001-08-29 |
| ORTELIUS 800 (K011827) | Orthoscan , Ltd. | 2001-08-28 |
| COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3 (K012431) | Bionostics, Inc. | 2001-08-28 |
| MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 (K012430) | Bionostics, Inc. | 2001-08-27 |
| QUIK-CHECK OVULATION PREDICTOR (K012252) | ACON Laboratories, Inc. | 2001-08-24 |
| RANDOX HUMAN ASSSAYED DRUG CONTROL (K012319) | Randox Laboratories, Ltd. | 2001-08-24 |
| LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS (K011749) | Sempermed USA, Inc. | 2001-08-22 |
| SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES (K012104) | Beijing Reagent Latex Products Co., Ltd. | 2001-08-21 |
| JAS URIC ACID LIQUID REAGENT (K012038) | Jas Diagnostics, Inc. | 2001-08-21 |
| VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002 (K012118) | Maine Standards Co. | 2001-08-20 |
| VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003 (K012119) | Maine Standards Co. | 2001-08-20 |
| VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005 (K012122) | Maine Standards Co. | 2001-08-20 |
| MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL (K012243) | Hematronix, Inc. | 2001-08-20 |
| VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004 (K012120) | Maine Standards Co. | 2001-08-20 |
| VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001 (K012117) | Maine Standards Co. | 2001-08-20 |
| SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE (K011765) | Sunmax Enterprise Shanghai Co. , Ltd. | 2001-08-16 |
| POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE (K012048) | Wrp Asia Pacific Sdn. Bhd. | 2001-08-16 |
| HADGEL, 4 GRAM/SYRINGE (K011544) | Seikagaku Corp. | 2001-08-15 |
| AMEDA HYGIENIKIT (K011519) | Hollister, Inc. | 2001-08-15 |
| SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES (K011717) | Sunmax Enterprise Shanghai Co. , Ltd. | 2001-08-14 |
| ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES (K011721) | Allegiance Healthcare Corp. | 2001-08-14 |
| GULLIVER AND CLASSE A (K012213) | American Dental Technologies, Inc. | 2001-08-13 |
| INSTRUMENTS FOR ONE TIME USE - DISPOSABLE (K011514) | Kencap , Ltd. | 2001-08-13 |
| CERVILENZ UTERINE MEASURING SOUND (K011840) | Cervilenz, Inc. | 2001-08-10 |
| OSSTELL RESONANCE FREQUENCY ANALYZER (K003714) | Integration Diagnostics, Ltd. | 2001-08-09 |
| MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION (K012286) | Roche Diagnostics Corp. | 2001-08-08 |
| MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION (K012287) | Roche Diagnostics Corp. | 2001-08-07 |
| STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE (K012282) | Cypress Medical Products, Ltd. | 2001-08-06 |
| SOLARA JR. MANUAL WHEELCHAIR (K012370) | Invacare Corp. | 2001-08-03 |
| POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K012135) | Wrp Asia Pacific Sdn. Bhd. | 2001-08-01 |
| POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR (K011791) | Latexx Partners Bhd. | 2001-08-01 |
| NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES (K011792) | Latexx Partners Bhd. | 2001-08-01 |
| MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR (K012167) | Invacare Corp. | 2001-08-01 |
| NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN) (K012166) | Best Manufacturing Company | 2001-08-01 |
| AUTOMATED WORKCELL CONTROL SOFTWARE (K010500) | Lab-Interlink, Inc. | 2001-08-01 |
| COPAN VIRAL TRANSYSTEM (K001780) | Copan Diagnostics, Inc. | 2001-07-31 |
| POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K011995) | Quality Latex Products Malaysia Sdn Bhd | 2001-07-31 |
| OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE (K011052) | Ostex Intl., Inc. | 2001-07-30 |
| LIPOPRINT SYSTEM, LDL SUBFRACTIONS (K010337) | Quantimetrix Corp. | 2001-07-25 |
| LATEX EXAMINATION GLOVES- POWDER FREE, BLUE (K011712) | Pt.Shamrock Manufacturing Corp. | 2001-07-17 |
| POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K011883) | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001-07-17 |