| REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (K012676) | Adven Medical | 2002-02-04 |
| POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K013254) | Top Quality Mfg., Inc. | 2002-02-04 |
| REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (K012694) | Adven Medical | 2002-02-04 |
| ROCHE COBAS TAQMAN ANALYZER (K012966) | Roche Molecular Systems, Inc. | 2002-02-01 |
| BIOTECH B990K VIVI WHEELCHAIR (K014198) | Taiwan Armada Enterprise Co., Ltd. | 2002-02-01 |
| MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX (K020077) | Augustine Medical, Inc. | 2002-01-31 |
| IDENT-A100 INTRAORAL VIDEO CAMERA (K013690) | Confident Technology, Inc. | 2002-01-30 |
| FINN CHAMBER (R) (K013820) | Epitest Ltd. OY | 2002-01-30 |
| NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM ON LABELING (K014055) | Seal Polymer Industries Bhd. | 2002-01-28 |
| IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE (K013938) | Diametrics Medical, Inc. | 2002-01-28 |
| SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR (K014103) | Beckman Coulter, Inc. | 2002-01-28 |
| CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER (K013303) | Latexx Manufacturing Sdn.Bhd. | 2002-01-23 |
| POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) (K020019) | Wrp Asia Pacific Sdn. Bhd. | 2002-01-23 |
| INTRAORAL LENS OPTION TO SPECTROSHADE (K012744) | Mht Optic Research AG | 2002-01-23 |
| POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K013794) | Shen Wei (Usa), Inc. | 2002-01-22 |
| POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) (K014134) | Supergrade Healthcare Products Sdn. Bhd. | 2002-01-22 |
| POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, GREEN COLOR (K013795) | Shen Wei (Usa), Inc. | 2002-01-22 |
| POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES (K013262) | Great Glove (Thailand) Co. , Ltd. | 2002-01-22 |
| POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN LABELING CLAIMS (K013793) | Shen Wei (Usa), Inc. | 2002-01-22 |
| UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES (K013163) | N.S. Uni-Gloves Sdn. Bhd. | 2002-01-22 |
| AUTION MAX AX-4280 URINALYSIS SYSTEM (K013783) | International Remote Imaging Systems | 2002-01-18 |
| ADVIA 1650 CHOLINESTERASE ASSAY (K013750) | Bayer Diagnostics Corp. | 2002-01-18 |
| CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K013498) | Maxter Glove Manufacturing Sdn Bhd | 2002-01-17 |
| BREATHTEK - UBIT UBT FOR H. PYLORI (K014225) | Meretek Diagnostics, Inc. | 2002-01-17 |
| POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K013554) | Maxter Glove Manufacturing Sdn Bhd | 2002-01-17 |
| MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 (K012789) | Morax | 2002-01-17 |
| SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9 (K013560) | Semperit Technische Produkte Gesellshaft | 2002-01-16 |
| MISONIX IRRIGATION SYSTEM MOEDL BC20P (K013417) | Misonix, Inc. | 2002-01-10 |
| CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA (K013589) | Supermax Glove Manufacturing Sdn Bhd | 2002-01-08 |
| BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER (K013304) | Becton Dickinson Infusion Therapy Systems, Inc. | 2002-01-02 |
| POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING) (K013942) | Wrp Specialty Products Sdn. Bhd. | 2001-12-31 |
| INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE (K013225) | Medafor, Inc. | 2001-12-26 |
| MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL (K013995) | Medical Analysis Systems, Inc. | 2001-12-21 |
| MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM (K013527) | Synthes (Usa) | 2001-12-21 |
| UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (K013371) | Otsuka Pharmaceutical Co., Ltd. | 2001-12-21 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS (K013900) | Ortho-Clinical Diagnostics | 2001-12-21 |
| SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 (K013466) | Helena Laboratories | 2001-12-21 |
| EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT (K013226) | Evenflo Company, Inc. | 2001-12-20 |
| DIGICAP (K012199) | Humana USA, Inc. | 2001-12-19 |
| ANISEIKONIA INSPECTOR (K013110) | Optical Diagnostics, Inc. | 2001-12-19 |
| BLUE LATEX EXAMINATION GLOVES, POWDER FREE (K013320) | Arista Latindo Industrial Ltd. P.T | 2001-12-19 |
| TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K013317) | Tekmedic (M) Sdn Bhd | 2001-12-17 |
| DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (K013302) | Allegiance Healthcare Corp. | 2001-12-17 |
| ASMOTOM AUTOMATED TREPHINE SYSTEM (K013151) | Bkg Opthalmics USA, Inc. | 2001-12-14 |
| GORE INTRODUCER SHEATH (K013282) | W. L. Gore & Associates, Inc. | 2001-12-14 |
| CONVOY ADVANCED DELIVERY SHEATH KIT (K013866) | Boston Scientific | 2001-12-14 |
| PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI (K013337) | Surgin, Inc. | 2001-12-13 |
| SAS STREPALERT (K013379) | Sa Scientific, Inc. | 2001-12-12 |
| OXOID PYLORI TEST KIT, MODEL DR0130M (K012588) | Oxoid , Ltd. | 2001-12-10 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K013753) | Canopus Medical Supply Co., Ltd. | 2001-12-10 |
| Z-NET (K001003) | Demite Limited | 2001-12-10 |
| LIGHT SABER INTRODUCER NEEDLE (K013040) | Minrad, Inc. | 2001-12-07 |
| STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G (K013727) | Smart Glove Corp. Sdn Bhd | 2001-12-07 |
| MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL (K013734) | Medical Analysis Systems, Inc. | 2001-12-07 |
| LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL CLAIM (K013333) | Innovative Gloves Co;, Ltd. | 2001-12-07 |
| ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K013537) | Koon Seng Sdn Bhd | 2001-12-07 |
| COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE (K013244) | Med Gen, Inc. | 2001-12-07 |
| MEDLINE EXCEL RECLINCER WHEELCHAIR (K013761) | Medline Industries, Inc. | 2001-12-06 |
| TCI-31 LIFELONG OVULATION TESTER (K013323) | Tci New York | 2001-12-05 |
| NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND VITAMIN E (K013288) | Sgmp Co., Ltd. | 2001-12-03 |
| IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM (K010166) | Imagyn Medical Technologies, Inc. | 2001-12-03 |
| OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) (K011043) | Osmetech | 2001-11-30 |
| BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST (K012521) | Binax, Inc. | 2001-11-30 |
| HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT (K013324) | Tillotson Healthcare Corp. | 2001-11-29 |
| POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2 (K013443) | Maxter Glove Manufacturing Sdn Bhd | 2001-11-29 |
| MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE (K013261) | Shanghai Motex Healthcare Co., Ltd. | 2001-11-29 |
| TCM ENDO III (K013185) | NOUVAG AG | 2001-11-28 |
| BACTI-SWAB DRY (K013711) | Remel Co. | 2001-11-26 |
| POWER DRIVE (K012944) | Mediteam AB | 2001-11-20 |
| VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007 (K013265) | Maine Standards Co. | 2001-11-20 |
| LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE (K013332) | Cliniqa Corporation | 2001-11-20 |
| COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES (K013239) | Med Gen, Inc. | 2001-11-20 |
| SMART GLOVE STERILE NITRILE EXAM GLOVE (K012853) | Smart Glove Corp. Sdn Bhd | 2001-11-16 |
| VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006 (K013119) | Maine Standards Co. | 2001-11-16 |
| SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9 (K012819) | Semperit Technische Produkte Gesellshaft | 2001-11-16 |
| STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS) (K012880) | Ssn Gloves (M) Sdn Bhd | 2001-11-16 |
| STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS) (K012896) | Ssn Gloves (M) Sdn Bhd | 2001-11-16 |
| STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G (K012856) | Smart Glove Corp. Sdn Bhd | 2001-11-16 |
| WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 (K013095) | Wiener Laboratories Saic | 2001-11-16 |
| IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE (K011586) | Diametrics Medical, Inc. | 2001-11-16 |
| TINA-QUANT APOLIPOPROTEIN A-1 VER.2 (K013278) | Roche Diagnostics Corp. | 2001-11-15 |
| SYMPHONY GRAFT DELIVERY SYSTEM (GDS) (K012738) | Depuyacromed | 2001-11-14 |
| NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116 (K013133) | Nordix, Inc. | 2001-11-13 |
| WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 (K013102) | Wiener Laboratories Saic | 2001-11-13 |
| WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 (K013097) | Wiener Laboratories Saic | 2001-11-13 |
| MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65 (K013603) | Ansell Healthcare Products, Inc. | 2001-11-13 |
| SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE (K012815) | Kimberly-Clark Corp. | 2001-11-13 |
| MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES (K013604) | Ansell Healthcare Products, Inc. | 2001-11-13 |
| ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS (K013152) | Elan Holdings, Inc. | 2001-11-09 |
| UNI-GOLD STREP A TEST KIT (K011709) | Trinity Biotech, Plc | 2001-11-08 |
| TULSA CONTRA ANGLES (K012720) | Dentsply Intl. | 2001-11-08 |
| WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 (K012326) | Wiener Laboratories Saic | 2001-11-08 |
| PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB (K011195) | Surgin Surgical Instrumentation, Inc. | 2001-11-06 |
| STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS (K012829) | Biocare Corp. | 2001-11-02 |
| ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR (K012714) | Koon Seng Sdn Bhd | 2001-10-31 |
| SEPRAGEL SINUS (K012532) | Genzyme Corp. | 2001-10-30 |
| TOURNIQUET CUFF; PNEUMATIC TOURNIQUET (K012632) | Medical Instruments Technology, Inc. | 2001-10-26 |
| GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE (K013147) | Bionostics, Inc. | 2001-10-24 |
| CONFORM SHEETING, MODEL IGEL (K012419) | Implantech Associates, Inc. | 2001-10-24 |
| MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER (K011392) | Micra Instruments | 2001-10-22 |