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

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RecordFirmDate
AROMATIC AND FLAVORED TONGUE DEPRESSOR (K992995)Aga Plastic Ind. Com. Ltda.1999-12-09
QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2 (K993631)Seracare Technology1999-12-09
QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3 (K992939)Seracare Technology1999-12-09
GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K993752)Glovco (M) Sdn. Bhd.1999-12-03
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS) (K993454)Sri Johani Sdn. Bhd.1999-12-03
LC COMPOSITE (K991492)Harry J. Bosworth Co.1999-12-02
CARESIDE ANALYZER (K993634)Careside, Inc.1999-12-02
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN LABELING CLAIM 50 MICROGRAM OR LESS (K993820)Felda Rubber Corp.1999-12-02
DERMAGRIP POWDER-FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING 50 MICROGRAMS OR LESS) (K993214)Wrp Specialty Products Sdn. Bhd.1999-12-02
QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 170 MICROGRAM OR LESS (K993271)Quality Latex Corp. Sdn Bhd1999-12-02
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS) (K993500)Besglove Medicare Sdn. Bhd.1999-12-02
MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE) (K993127)Glovesworld Industries Sdn. Bhd.1999-12-02
DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE (K993215)Wrp Specialty Products Sdn. Bhd.1999-12-02
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS] (K993457)Sri Johani Sdn. Bhd.1999-12-02
TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3 (K993546)Medical Analysis Systems, Inc.1999-11-30
ELECSYS PARATHYROID HORMONE CALCHECK (K993642)Roche Diagnostics Corp.1999-11-30
APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH (K993310)Dade Behring, Inc.1999-11-30
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K992862)Shijiazhuang Great Vision Plastic Products Co., LT1999-11-29
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS (K993023)Beckman Coulter, Inc.1999-11-26
MODIFICATION TO DOCUMENT THYROID CAL.VER (K993014)Casco-Nerl Diagnostics Corporation (Maine)1999-11-26
TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION (K981914)The Binding Site, Ltd.1999-11-26
NEW MULTIPLES REAGENT STRIPS (K992257)Bayer Corp.1999-11-24
PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA (K993360)Roche Diagnostics Corp.1999-11-24
POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS) (K993495)Besglove Medicare Sdn. Bhd.1999-11-24
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS) (K993502)Besglove Medicare Sdn. Bhd.1999-11-24
K-ASSAY ALPHA-1 AG (K993441)Kamiya Biomedical Co.1999-11-24
ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK (K992710)Abbott Laboratories1999-11-24
PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA (K992900)Roche Diagnostics Corp.1999-11-24
BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS. (K993722)Hartalega Sdn Bhd1999-11-23
GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS (K993725)Hartalega Sdn Bhd1999-11-23
COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE (K993313)Wrp Asia Pacific Sdn. Bhd.1999-11-23
SIRSCAN (K991473)Intelligence Artificielle Applications1999-11-23
NIL, SURGEON'S GLOVE - POWDER FREE (K993349)Sri Anusham Rubber Industries Pvt., Ltd.1999-11-23
STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS (K990512)Stoeckert Instrumente1999-11-23
CARDIASURE CARDIAC MARKERS CONTROL (K993723)Quantimetrix Corp.1999-11-23
COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE (K993311)Wrp Asia Pacific Sdn. Bhd.1999-11-19
POWDER FREE GLOVES (POLYMER COATED) (K993183)Pan-Century Rubber Products Sdn. Bhd.1999-11-19
OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS) (K993479)Omnigrace (Thailand) , Ltd.1999-11-19
DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES (K993049)Shanghai Antares Industries, Inc.1999-11-19
NIL, NITRILE EXAMINATION GLOVE - POWDER FREE (K993348)Sri Anusham Rubber Industries Pvt., Ltd.1999-11-19
NIL, NITRILE EXAMINATION GLOVE - POWDERED (K993347)Sri Anusham Rubber Industries Pvt., Ltd.1999-11-19
OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS) (K993419)Omnigrace , Ltd.1999-11-19
COLORMAX COLOR VISION ENHANCEMENT LENSES (K984219)Color Vision Technologies, Inc.1999-11-18
PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED (K992678)Wear Safe Malaysia Sdn. Bhd.1999-11-17
NON-STERILE POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (70 MICROGRAMS OR LESS PER (K993326)Seal Polymer Industries Bhd.1999-11-17
CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN (K993133)Seal Polymer Industries Bhd.1999-11-17
CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN) (K993134)Seal Polymer Industries Bhd.1999-11-17
E Z CHAIR (K993298)Premier Designs1999-11-16
QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 (K993715)Seracare Technology1999-11-16
RICROKERATOME BLADE (K992978)Surgistar, Inc.1999-11-16
SPECTRUM LIBRE WHEELCHAIR (K993640)Freedom Designs, Inc.1999-11-16
QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3 (K992770)Seracare Technology1999-11-12
MICROALBUSTIX REAGENT STRIPS (OTC) (K991315)Bayer Corp.1999-11-12
VACUUM ASSIST STABILIZER (K992833)Cardio Thoracic Systems1999-11-10
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (K993458)Sri Johani Sdn. Bhd.1999-11-10
COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM (K993161)Copan Diagnostics, Inc.1999-11-09
LYPHOCHEK ANEMIA CONTROL, MODEL 500 (K992741)Bio-Rad1999-11-09
WAKO L-TYPE TRIGLYCERIDE TEST (K993466)Wako Chemicals USA, Inc.1999-11-09
OSTEOMARK NTX POC (K992997)Metrika, Inc.1999-11-09
WAKO L-TYPE UA F TEST (K993469)Wako Chemicals USA, Inc.1999-11-09
OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED (K993050)Omnigrace , Ltd.1999-11-09
EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM (K992702)Allergy Direct1999-11-08
INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES, PREPOWDERED (K993221)Innovative Gloves Co;, Ltd.1999-11-05
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES (K992797)Shijiazhuang Hongxiang Plastics Products Co., Ltd.1999-11-05
SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5 (K992752)Pt. Maja Agung Latexindo1999-11-05
INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES POWDERFREE (K993222)Innovative Gloves Co;, Ltd.1999-11-05
INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE (K993325)Innovative Gloves Co;, Ltd.1999-11-05
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES (K993247)Jda Intl., Inc.1999-11-05
QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED (K992924)Latexx Partners Bhd.1999-11-05
CDTOX A OIA (K991829)Biostar, Inc.1999-11-02
TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4. (K992310)Rupiani Medical1999-11-02
SERAQUEST EB NA IGG (K991975)Quest Intl., Inc.1999-11-02
KSEA DE LA PLAZA BLEPHAROPLASTY SET (K991592)KARL STORZ Endoscopy-America, Inc.1999-11-02
WHEELCHAIR (MANUAL, NOT ELECTRICAL) (K992884)Foshan Machinery & Equipment Import & Export Co.1999-11-02
ABSOGEL CHEMOTHERAPHY GLOVES (K990677)Ampri Rubberware Industries Sdn Bhd1999-11-01
TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES (K992841)Tg Medical Sdn. Bhd.1999-10-29
ATD AUTOMATIC BRIDGE REMOVER (K992649)J. Morita USA, Inc.1999-10-29
SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM (K992953)Ansell Perry1999-10-29
HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS) (K993093)Pamitex Industries Sdn Bhd1999-10-29
POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (K993287)Pan-Century Rubber Products Sdn. Bhd.1999-10-29
SERAQUEST EB VCA IGG (K990410)Quest Intl., Inc.1999-10-28
SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES (K992156)Ansell Perry1999-10-27
SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE (K992830)Safeskin Corp.1999-10-27
SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES (K993258)Supermax Sdn Bhd1999-10-27
PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES (K983613)Shanghai Jiatai Plastic Products Co., Ltd.1999-10-27
SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES (K993240)Shinemound Enterprise, Inc.1999-10-27
SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES (K993231)Shinemound Enterprise, Inc.1999-10-27
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATINO GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAM (K993097)Pamitex Industries Sdn Bhd1999-10-27
SPECTRUM DESIGNS SPECTRAGEL (K992522)Spectrum Designs, Inc.1999-10-26
HYBRID CAPTURE II CT-ID TEST (K990023)Digene Corp.1999-10-25
AMBU HAND POWER SUCTION PUMP (K992902)Ambu, Inc.1999-10-25
SCAREASE SHEETS & SCAREASE GEL (K991970)Pillar Surgical1999-10-25
STENTOR, PAGEVIEW (K992698)Stentor, Inc.1999-10-25
PACIFIC IMPLANT TITANIUM ENDODONTIC POINT (K992582)Pacific Implant, Inc.1999-10-21
SURGEON POWDER-FREE GLOVES, LATEX, STERILE (K992679)Wear Safe Malaysia Sdn. Bhd.1999-10-21
AMBIDERM LATEX EXAMINATION GLOVES (VIOLET, BLUE , GREEN, AND PINK) CONTAINING 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE (K993080)Medtexx Partners, Inc.1999-10-20
N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET (K992766)Genzyme Corp.1999-10-18
DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE (K990752)Wrp Specialty Products Sdn. Bhd.1999-10-18
REP CHOLESTEROL PROFILE KIT (K992971)Helena Laboratories1999-10-18
HEALTH-PLUS SANITEX,RELIANCE PRE-POWDERED MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION W (K992523)Pamitex Industries Sdn Bhd1999-10-18
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