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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS (K993760)Hartalega Sdn Bhd2000-05-15
NUZONE NITRILE SURGICAL GLOVES POWDER FREE (K000179)Terang Nusa Sdn Bhd2000-05-15
COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES (K001280)Wrp Asia Pacific Sdn. Bhd.2000-05-15
MD 10, SEM, SM 12, CBM (K000710)NOUVAG AG2000-05-11
POWDER FREE STERILE LATEX EXAMINATION GLOVES (K001141)Allegiance Healthcare Corp.2000-05-09
VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES (K000457)Retinalabs.Com2000-05-09
YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA (K000577)The Yoshida Dental Mfg. Co., Ltd.2000-05-05
ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS (K001144)Lasersight Technologies, Inc.2000-05-05
SERIM LEUKOCYTE ESTERASE TEST STRIPS (K000578)Serim Research Corp.2000-05-05
CLINI-DENT (K000140)The Precident Group2000-05-03
4631 DUO DELIVERY SYSTEM (K000966)A-Dec, Inc.2000-05-03
POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K991422)Shen Wei (Usa), Inc.2000-05-03
SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM (K000745)Tillotson Healthcare Corp.2000-05-03
ATR TECNIKA (K000547)Advanced Technology Research (A.T.R.) S.R.P.2000-05-03
3181 DUO DELIVERY SYSTEM (K000968)A-Dec, Inc.2000-05-03
POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS (K000896)Fitco Dipped Products Pvt., Ltd.2000-05-03
4635 ASSISTANT'S INSTRUMENTATION (K000967)A-Dec, Inc.2000-05-03
WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 (K000327)Visx, Incorporated2000-05-02
ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS (K000900)Elan Holdings, Inc.2000-05-02
DIRECT TIBC KIT (K000781)Reference Diagnostics, Inc.2000-05-02
POWDER-FREE NON-VHLORINATED POLYMER COATED LATEX EXAMINATION GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRA (K000668)Protection Gloves Sdn. Bhd.2000-04-28
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER LABEL CLAIM (K000667)Protection Gloves Sdn. Bhd.2000-04-28
STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES (K000891)Fitco Dipped Products Pvt., Ltd.2000-04-28
POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K001216)Fitco Dipped Products Pvt., Ltd.2000-04-28
HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES (K993756)Pamitex Industries Sdn Bhd2000-04-28
GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED) (K001047)Guthrie Medicare Products (Melaka) Sdn Bhd2000-04-28
UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES (K000689)N.S. Uni-Gloves Sdn. Bhd.2000-04-28
SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES (K001094)Jb Star Sdn Bhd2000-04-28
ELECSYS THYROGLOBULIN CALCHECK (K001015)Roche Diagnostics Corp.2000-04-27
MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS (K000985)Matang Mfg. Sdn. Bhd.2000-04-24
POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR (K000867)Sgmp Co., Ltd.2000-04-21
KSEA CHARDONNES MORCELLATION KNIFE (K000212)KARL STORZ Endoscopy-America, Inc.2000-04-21
ASSAYED QCS 1,2, CAT. NOS. 970200, 970500 (K000875)Bio-Rad2000-04-20
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K000953)Shanghai Antares Industries, Inc.2000-04-20
NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES (K000868)Sgmp Co., Ltd.2000-04-20
BETEL POWDER FREE LATEX EXAM GLOVES (K000650)Betel Care Sdn. Bhd.2000-04-20
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 (K000874)Bio-Rad2000-04-18
SPIFE CHOLESTEROL PROFILE KIT (K000603)Helena Laboratories2000-04-17
DRG AURICA ELISA TESTOSTERONE KIT (K000043)Drg Intl., Inc.2000-04-17
LAZERSMILE, LAZERWHITE (K000290)Biolase Technology, Inc.2000-04-14
PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE (K000971)Wrp Asia Pacific Sdn. Bhd.2000-04-14
TENAX WHITE POST (K993545)Coltene/Whaledent, Inc.2000-04-14
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE (K000223)Phoenix Medical Technology, Inc.2000-04-14
RANDOX PREALBUMIN (K000661)Randox Laboratories, Ltd.2000-04-13
ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401 (K000112)Dentsply Intl.2000-04-13
QUALITROL LIPID CONTROL, LEVELS 1 AND 2 (K000810)Consolidated Technologies of Wisconsin2000-04-13
IQ CHAMBERS (K992553)Dormer Laboratories, Inc.2000-04-12
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K000584)Shasta Asia Partners Gloves Manufacturing CO , Ltd.2000-04-12
UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES (K000688)N.S. Uni-Gloves Sdn. Bhd.2000-04-12
VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED (K994099)Evergreen Medical Produts (Jingxing) Co., Ltd.2000-04-12
REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE) (K991677)London International Group, Inc.2000-04-12
NITRILE EXAM GLOVE, POWDER FREE, BLUE (K000670)Shasta Asia Partners Gloves Manufacturing CO , Ltd.2000-04-12
VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K000391)Sgmp Co., Ltd.2000-04-12
VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K000390)Sgmp Co., Ltd.2000-04-12
TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O (K000555)Tekmedic (M) Sdn Bhd2000-04-12
BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K000652)Betel Care Sdn. Bhd.2000-04-10
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 (K000528)Sigma Diagnostics, Inc.2000-04-07
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 (K000527)Sigma Diagnostics, Inc.2000-04-07
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE (K000828)Pamitex Industries Sdn Bhd2000-04-07
STERLTECH WATER PURIFIER (K000941)Sterltech, Inc.2000-04-06
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE (K000330)Siam Sempermed Corp., Ltd.2000-04-05
HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) (K000725)Hwa Teh Industrial Sdn. Bhd.2000-04-05
ARCHITECH AFP MASTERCHECK, MODEL 6C01-05 (K992781)Bio-Rad2000-04-05
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K000872)Shanghai Antares Industries, Inc.2000-04-05
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE (K000329)Siam Sempermed Corp., Ltd.2000-04-05
NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE (K000323)Siam Sempermed Corp., Ltd.2000-04-05
SUNI MAX (K000049)Satelec2000-04-04
POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN LABELING (K000671)Sgmp Co., Ltd.2000-03-29
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES (K992554)Shijiazhuang Great Vision Plastic Products Co., LT2000-03-29
HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES (K993201)Pamitex Industries Sdn Bhd2000-03-29
NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN (K000169)Dentsply Intl.2000-03-24
BLADEWORKS MICROKERATOME BLADE (K993225)Blade Works, Inc.2000-03-20
VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB (K000488)Sgmp Co., Ltd.2000-03-20
SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES (K000644)Supermax Glove Manufacturing Sdn Bhd2000-03-17
ELECSYS B-CROSSLAPS CALCHECK (K000042)Roche Diagnostics Corp.2000-03-17
MSP M/K BLADE (K993122)Medical Sterile Products, Inc.2000-03-16
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 (K994015)Surgin Surgical Instrumentation, Inc.2000-03-15
PARAPOST FIBER WHITE (K000311)Coltene/Whaledent, Inc.2000-03-14
BITEM LOCK, MODELS SW006, SW012 (K994357)Thermoelastic Technologies, Inc.2000-03-14
HYLASINE (K993362)Biomatrix, Inc.2000-03-13
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K992821)Shijiazhuang Hongxiang Plastics Products Co., Ltd.2000-03-10
NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM (K000165)Ansell Perry2000-03-10
NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVES (BLUE, CHERRY FLAVORED) (K993805)Best Manufacturing Company2000-03-10
BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES (K000058)Kaohsiung Brothers Products Corp.2000-03-10
BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 (K000544)Labtician Ophthalmics, Inc.2000-03-09
VOYAGER/VIPER WHEELCHAIR (K000497)Otto Bock Orthopedic Industry, Inc.2000-03-08
SAS STREP A TEST (K993456)Sa Scientific, Inc.2000-03-07
ELECSYS CORTISOL TEST SYSTEM (K000270)Roche Diagnostics Corp.2000-03-07
PROTEGE WHEELCHAIR (K000602)Otto Bock Orthopedic Industry, Inc.2000-03-03
BACT/ALERT MB CULTURE BOTTLE (K000378)Organon Teknika Corp.2000-03-02
MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE (K993811)Multisafe Sdn. Bhd.2000-03-02
SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG (K993117)Safeskin Corp.2000-03-02
TOOTHBRUSH WASH (K994144)Cal Huech, Inc.2000-03-02
TRIAGE BNP CALIBRATION VERIFICATION CONTROLS (K000231)Biosite Incorporated2000-03-02
DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR (K000226)Sheen More Ent. Co., Ltd.2000-03-02
PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES (K994151)Ximed/Prosure/Injectx2000-03-01
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS (K000230)Biosite Incorporated2000-02-29
SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES (K000071)Shijiazhuang Great Eagle Plastic Products Co., Ltd.2000-02-29
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (K000318)Bionostics, Inc.2000-02-28
DRYSPOT E.COLI 0157 KIT (K993401)Oxoid , Ltd.2000-02-28
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