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

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RecordFirmDate
TENDER TOUCH SILICONE GEL PADS (K991478)Capital Marketing Technologies, Inc.1999-06-21
QUANTASE TOTAL GALACTOSE SCREENING ASSAY (K990644)Quantase , Ltd.1999-06-21
POWDERED VINYL EXAMINATION GLOVE (K983893)Shijiazhuang Brethern Plastic Co., Ltd.1999-06-21
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (K991155)C.V. Anlis Abadi International1999-06-21
QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT (K990654)Quantase , Ltd.1999-06-21
MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTA\ (K991153)Medtexx Industries (Thai) Co. , Ltd.1999-06-21
HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0 (K990250)Morax1999-06-18
DIRECT HDL-CHOLESTEROL REAGENT (K990581)Kamiya Biomedical Co.1999-06-18
ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL (K991498)Neometrics, Inc.1999-06-16
CARDIOQUANT CARDIAC ASSESSMENT CONTROLS (K991447)Spectral Diagnostics, Inc.1999-06-11
ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET (K991630)Advanced Medical Solutions Group Plc1999-06-11
LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS) (K991686)Arista Latindo Industrial Ltd. P.T1999-06-11
BIOTEST ANTI-EBV RECOMBINANT (K983839)Biotest Diagnostics Corp.1999-06-09
ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET (K990954)Nsk Nakanishi, Inc.1999-06-09
EPI-FOAM SILICONE SHEETING (K991604)Biodermis Corp.1999-06-09
BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG (K983841)Biotest Diagnostics Corp.1999-06-09
BIOTEST ANTI-EBV RECOMBINANT, EA IGM (K983842)Biotest Diagnostics Corp.1999-06-09
COPALIS MULTIPLEX EBV ANTIBODY ASSAY (K991660)DiaSorin, Inc.1999-06-04
POWDER FREE BLUE NITRILE GLOVE (K990668)Tg Medical Sdn. Bhd.1999-06-03
POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED) (K991511)Perusahaan Getah Asas Sdn. Bhd.1999-06-03
A P HARNESS (K981860)Paraworks Enterprise, Ltd.1999-06-03
KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM (K990154)Karl Storz Imaging, Inc.1999-06-01
SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS (K991302)Smartlight, Inc.1999-06-01
AVOGEL (K981353)Avocet Polymer Technologies, Inc.1999-06-01
QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED (K991462)Latexx Partners Bhd.1999-05-28
SMARTPREP CENTRIFUGE SYSTEM (K991430)Harvest Technologies, LLC1999-05-28
LATEX EXAMINATION GLOVES- POWDER FREE, SIZES EXTRA SMALL, SMALL,MEDIUM,LARGE,EXTRA LARGE (K991158)P. T. Tata Rubberindo Industries1999-05-28
STARDENTAL AXCS STERILE WATER SYSTEM (K990844)Dentalez Group1999-05-28
HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES (K991640)M.R.G. Industries Berhad1999-05-28
SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE (K990488)Terang Nusa Sdn Bhd1999-05-28
MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 (K990247)Polymer Technology Systems, Inc.1999-05-28
GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM (K991156)Great Smokies Diagnostic Laboratory1999-05-28
QUANTEC-E ENDO SYSTEM (K990739)Sybron Dental Specialties, Inc.1999-05-26
SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES (K991415)Supermax Sdn Bhd1999-05-26
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES (K991493)Masju Sdn. Bhd.1999-05-26
RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE) (K990963)Riverstone Resources Sdn Bhd1999-05-26
TOTAL IRON, MODELS FE 109-01, FE 109-02 (K991244)A.P. Total Care, Inc.1999-05-25
EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) (K991466)Selfcare, Inc.1999-05-25
EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) (K991386)Selfcare, Inc.1999-05-25
URIC ACID, MODEL UA112-01 (K991247)A.P. Total Care, Inc.1999-05-25
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE) (K990878)Brightway Holdings Sdn. Bhd.1999-05-21
POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM (K991317)Safeskin Corp.1999-05-21
LAGLOVE BRAND COLORED NITRILE EXAMINATION GLOVES (POWDER FREE) (K990882)La Glove (M) Sdn. Bhd.1999-05-21
SURGEON'S GLOVES (K984395)Sri Anusham Rubber Industries Pvt., Ltd.1999-05-21
POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES (K990690)Top Glove Sdn. Bhd.1999-05-20
BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES (K990710)Barriermed Glove Co.1999-05-20
VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS (K990016)Ortho-Clinical Diagnostics, Inc.1999-05-19
MODIFICATION OF N/T PROTEIN CONTROL SL (K991182)Dade Behring, Inc.1999-05-19
MODIFICATION OF:BIODERM FOAM WOUND DRESSING (K990955)Bioderm, Inc.1999-05-18
PRE POWDERED LATEX EXAMINATION GLOVES (K990879)Apl Products Sdn. Bhd.1999-05-17
NUGARD NITRIL NITRILE EXAMINATION GLOVE (K990841)Terang Nusa Sdn Bhd1999-05-17
LATEX EXAMINATION GLOVES (POWDERED) (K984229)Sama Kejuruteraan Sdn.Bhd.1999-05-17
NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE (K990840)Terang Nusa Sdn Bhd1999-05-17
COPALIS EBV-M ANTIBODY ASSAY (K991459)DiaSorin, Inc.1999-05-14
KERATOME SYSTEM, MODEL K3000 (K984537)Insight Technologies Instruments, LLC1999-05-14
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE (K990698)Omnigrace (Thailand) , Ltd.1999-05-13
3M CLINPRO PROPHY PASTE, MODEL 12611 (K990482)Minnesota Mining and Mfg. Co.1999-05-13
HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR (K990479)Hygenitek, Inc.1999-05-13
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE (K990696)Omnigrace (Thailand) , Ltd.1999-05-13
ATLAST GLUCOSE CONTROL SOLUTION (K991075)Amira Medical, Inc.1999-05-10
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE (K990701)Omnigrace (Thailand) , Ltd.1999-05-05
BROTHERS, VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES (K991085)Long First (Xiamen) Co., Ltd.1999-05-05
LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN (K991043)Glovco (M) Sdn. Bhd.1999-05-04
TA CHIA POWDER FREE NON-STERILE NITRILE PATIENT EXAMINATION GLOVES (K990577)Ta Chia Rubber Ind. Corp.1999-05-04
ORALGIENE TONGUE CLEANER (K990344)Oralgiene USA, Inc.1999-05-04
POWDER FREE LATEX EXAMINATION GLOVES (K990686)Tower Rubber Industries Sdn. Bhd.1999-05-04
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE (K990695)Omnigrace (Thailand) , Ltd.1999-05-04
BROTHERS VINYL, POWDERED, PATIENT EXAMINATION GLOVES (K990946)Long First (Xiamen) Co., Ltd.1999-05-04
POWDER FREE LATEX EXAMINATION GLOVES (K990901)Apl Products Sdn. Bhd.1999-05-04
TA CHIA POWDERED NON-STERILE NITRILE PATIENT EXAMINATION GLOVES (K990575)Ta Chia Rubber Ind. Corp.1999-05-04
POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTA (K990812)Ampri Rubberware Industries Sdn Bhd1999-05-04
OMNI GRACE LATEX EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED WITH PROTEIN CLAIM (K990702)Omnigrace (Thailand) , Ltd.1999-05-04
SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (K983982)Maxxim Medical1999-05-04
SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE (K984249)London International Group, Inc.1999-05-04
HYDRO-CAST ACRYLIC VARNISH, MODEL 78125 (K991161)Kay See Dental Mfg. Co.1999-04-29
KENSTONE (K990139)Kenda USA1999-04-29
SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL CAMERA, SPECTRA VU HDDI SV I INTRAORAL CAMERA, (K984332)International Technology Concepts1999-04-29
FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER (K990906)Ferris Mfg. Corp.1999-04-29
KERAVISION VACUUM RING SYSTEM (K984540)Keravision, Inc.1999-04-28
EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 (K990971)Medica Corp.1999-04-27
ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10 (K990610)Bio-Rad1999-04-27
LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING (K990468)Top Glove Sdn. Bhd.1999-04-27
X-TIP INTRAOSSEOUS PERFORATOR (K990511)Schiff & Co.1999-04-27
KLEENHANDS POWDERED LATEX EXAMINATION GLOVES (K990527)Ssn Gloves (M) Sdn Bhd1999-04-23
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR. (K990486)Alliance Rubber Products Sdn. Bhd.1999-04-23
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR (K990485)Alliance Rubber Products Sdn. Bhd.1999-04-23
KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (K990526)Ssn Gloves (M) Sdn Bhd1999-04-23
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING) (K991044)Wrp Specialty Products Sdn. Bhd.1999-04-23
ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE (K990427)Alliance Rubber Products Sdn. Bhd.1999-04-23
S575 INTRAORAL DOCKING DENTAL CAMERA (K990948)Sopro1999-04-21
LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 (K990928)Bio-Rad1999-04-16
STRAUMANN EXTRAORAL IMPLANT SYSTEM (K990458)Straumann USA1999-04-16
NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS (K984213)Capital Marketing Technologies, Inc.1999-04-14
WOUND DRESSING/ABD PAD, MODEL #10810 (K990861)Hospital Specialty Co.1999-04-12
BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE) (K990539)Brightway Holdings Sdn. Bhd.1999-04-09
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) (K990542)Brightway Holdings Sdn. Bhd.1999-04-09
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE) (K990541)Brightway Holdings Sdn. Bhd.1999-04-09
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN) (K990540)Brightway Holdings Sdn. Bhd.1999-04-09
ELASTYLON POWDER-FREE SURGICAL GLOVE (K984337)Eci Medical Technologies, Inc.1999-04-09
BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE) (K990543)Brightway Holdings Sdn. Bhd.1999-04-09
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