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

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RecordFirmDate
DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERILE (K990750)Wrp Specialty Products Sdn. Bhd.1999-10-15
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI (K992870)Alliance Rubber Products Sdn. Bhd.1999-10-15
BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER (K992435)Azo Enterprises1999-10-15
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K992555)Shijiazhuang Great Vision Plastic Products Co., LT1999-10-14
NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE (K992768)Ansell Perry1999-10-13
SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE (K992865)Maxxim Medical1999-10-13
RAYPAX WEB CLINICAL SYSTEM (K992426)Samsung Sds Co., Ltd.1999-10-13
ENDO-EZE MOTOR AND HANDPIECE (K992380)Ultradent Products, Inc.1999-10-13
ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K991205)Allegiance Healthcare Corp.1999-10-13
TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES (K992360)Tg Medical Sdn. Bhd.1999-10-12
QUANTEC-E IRRIGATION SYSTEM 2 (K992195)Sybron Dental Specialties, Inc.1999-10-08
AIRFLOW HANDY (K991857)Electro Medical Systems, Inc.1999-10-07
HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED MULTI-PLY EXAMINATION GLOVE, (NATURAL LATEX LAMINATED WITH NITRILE, EXTERNA (K991474)Pamitex Industries Sdn Bhd1999-10-06
SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (K992922)Shijiazhuang Hongray Plastic Products Co., Ltd.1999-10-06
SERAQUEST EB VAC IGM (K990977)Quest Intl., Inc.1999-10-06
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K992861)Shijiazhuang Great Eagle Plastic Products Co., Ltd.1999-10-06
MINI-PORT (K992904)Taut, Inc.1999-10-05
INTRADUCER (K992907)Taut, Inc.1999-10-05
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES (K992271)Shanghai Cosmos Corp.1999-10-01
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K992272)Shanghai Cosmos Corp.1999-10-01
ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0 (K992352)Inteleradiology, Inc.1999-09-29
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P (K992798)Sigma Diagnostics, Inc.1999-09-28
ENDOSTEPPER 1 (K993188)Phytron- Elektronik GmbH1999-09-28
PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER (K992117)Pamitex Industries Sdn Bhd1999-09-27
HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE (K992810)Hwa Teh Industrial Sdn. Bhd.1999-09-27
NITRILE PATIENT EXAMINATION GLOVES, POWDERED, NON-STERILE (K992558)Riverstone Resources Sdn Bhd1999-09-27
EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED (K992175)Ultrawin Sdn Bhd1999-09-24
DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR (K992686)Sheen More Ent. Co., Ltd.1999-09-24
BACT/ALERT FN (K992432)Organon Teknika Corp.1999-09-24
AVCORE SYSTEM (K990816)Modular Cutting Systems, Inc.1999-09-24
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (K992860)Shijiazhuang Hongray Plastic Products Co., Ltd.1999-09-24
QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES (K992671)Latexx Partners Bhd.1999-09-24
HEMOCHEK URINE COLLECTION KIT (K991800)Osborn Group, Inc.1999-09-24
MICROKERATOME, MODEL MK-2000 (K990900)Nidek, Inc.1999-09-24
EZ-HBT HELICOBACTER BLOOD TEST (K990931)Metabolic Solutions, Inc.1999-09-24
MILLENIUM MICROKERATOME, MODEL IMD-001 (K992687)Industrial & Medical Design, Inc.1999-09-24
MIRACLEBREATH TONGUE CLEANER (K992270)Stellar Labs, Inc.1999-09-23
HEALTH-PLUS, SANITEX, RELIANCE POWER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM 73.13 MICROGRAMS O (K992364)Pamitex Industries Sdn Bhd1999-09-22
GILTECH PLUS HYDROGEL SKIN DRESSING (K992094)Giltech Plus, Inc.1999-09-17
DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS (K992128)Dash Medical Gloves Sdn Bhd1999-09-14
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES (K992464)Shijiazhuang Dilly Plastics Products Co., Ltd.1999-09-14
HYDROFERA BACTERISTATIC NASAL DRESSING (K983276)Hydrofera, LLC1999-09-14
CONTROL III ELITE (K992661)Maril Products, Inc.1999-09-14
COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K992171)Allegiance Healthcare Corp.1999-09-14
QUALATEX POWDERED LATEX EXAMINATION GLOVES (K992557)Tan Sin Lian Industries Sdn. Bhd.1999-09-14
HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE (K992730)Hwa Teh Industrial Sdn. Bhd.1999-09-14
ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR (K992417)Shield Gloves Manufacturer (M) Sdn Bhd1999-09-13
SAMSUNG RAYPAX LONG TERM ARCHIVE (K992131)Samsung Sds Co., Ltd.1999-09-13
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP (K992803)Sigma Diagnostics, Inc.1999-09-13
ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR (K992419)Shield Gloves Manufacturer (M) Sdn Bhd1999-09-13
ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH AND WITHOUT STRAWBERRY SCENT AND WITH PROTEI (K992418)Shield Gloves Manufacturer (M) Sdn Bhd1999-09-13
BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE (K992588)Formosa Glove Industrial Co., Ltd.1999-09-10
SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES (K992210)Safeskin Corp.1999-09-10
SYNEA-HS HIGH SPEED-HANDPIECE (K992011)A-Dec, Inc.1999-09-10
CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE) (K992358)Biopro (M) Sdn Bhd1999-09-10
HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (137 MCG OR LESS) (K991969)Pamitex Industries Sdn Bhd1999-09-09
CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 (K991834)Cholestech Corp.1999-09-09
DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE (K992893)Mrlb Intl., Inc.1999-09-08
N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE (K992170)Best Manufacturing Company1999-09-07
DENTAPURE DP40 CARTRIDGE (K992868)Mrlb Intl., Inc.1999-09-07
MUMPS IGG ELISA TEST SYSTEM (K991274)Columbia Bioscience, Inc.1999-09-03
URINE CHEMISTRY CONTROL, LEVEL 1 (K992576)Consolidated Technologies, Inc.1999-09-03
STECO-TITANMAGNETICS (K990979)Steco-System-Technik GmbH & Cokg1999-09-03
ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L (K991946)Sterilex Corp.1999-09-03
URINE CHEMISTRY CONTROL, LEVEL 2 (K992578)Consolidated Technologies, Inc.1999-09-03
BACT/ALERT PF (K992401)Organon Teknika Corp.1999-09-03
BACTALERT FA (K992400)Organon Teknika Corp.1999-09-03
FLEXIBLADE (K984101)Arco Medic , Ltd.1999-09-03
IS H. PYLORI IGG ELISA TEST SYSTEM (K990462)Columbia Bioscience, Inc.1999-09-03
MAGNESIUM PRODUCT NO'S, 112-01, 112-02 (K991761)A.P. Total Care, Inc.1999-09-02
LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580 (K992172)Bio-Rad1999-09-02
DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE (K990873)Ameritek, Inc.1999-09-01
LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN) (K991777)Seltom Pacific Sdn. Bhd.1999-08-31
LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE) (K991778)Seltom Pacific Sdn. Bhd.1999-08-31
SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM (K992162)Safeskin Corp.1999-08-30
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K992463)Shijiazhuang Dilly Plastics Products Co., Ltd.1999-08-30
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 (K992430)Medical Analysis Systems, Inc.1999-08-30
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE (K992223)Pamitex Industries Sdn Bhd1999-08-30
BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI (K991726)Binax, Inc.1999-08-27
FERRIS POLYOSTOMY STERILE WOUND DRESSING (K991729)Ferris Mfg. Corp.1999-08-27
URINE DRUG SCREENING CONTROL (K992395)Seracare Technology1999-08-26
PICCOLO METLYTE 7 REAGENT DISC (K992140)Abaxis, Inc.1999-08-26
POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) (K992496)Kossan Latex Industries(M)Sdn Bhd1999-08-25
POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) (K992497)Kossan Latex Industries(M)Sdn Bhd1999-08-25
SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES (K992062)Safeskin Corp.1999-08-25
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLOVE (K992165)Pamitex Industries Sdn Bhd1999-08-25
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS (K992349)Ortho-Clinical Diagnostics, Inc.1999-08-24
QS DELIVERY SYSTEM (K991254)Sub-Q, Inc.1999-08-23
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE (K992299)Pamitex Industries Sdn Bhd1999-08-23
BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES (K992107)General Gloves Corp.1999-08-23
CHOLESITE TEST SYSTEM (K992132)Gds Technology, LLC1999-08-20
SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING (K991312)Library Medical, Inc.1999-08-20
RLP CHOLESTEROL IMMUNOSEPARATION ASSAY (K991083)Otsuka Pharmaceutical Co., Ltd.1999-08-20
SAS ADENO TEST (K990630)Sa Scientific, Inc.1999-08-19
STREP B OIA (K991828)Biostar, Inc.1999-08-19
LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 (K991664)A.P. Total Care, Inc.1999-08-19
ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033 (K992032)Acrymed, Inc.1999-08-19
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GREEN, CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE (K992200)Shen Wei (Usa), Inc.1999-08-17
BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA (K992337)Mexpo Intl., Inc.1999-08-17
KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT (K991958)Kiel Laboratories, Inc.1999-08-13
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