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

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RecordFirmDate
PATIENT EXAMINATION GLOVES (NATURAL LATEX) (K891967)Butex Products (M'Sia) Sdn.Bhd1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K892611)Yty Industry (Manjung) Sdn Bhd1989-07-14
LATEX EXAMINATION GLOVES (K893101)Li DA Latex Factory1989-07-14
PATIENT EXAMINATION GLOVES (K892487)Allied Rubber Industries Sdn. Bhd.1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K892570)Ansell Pacific, Inc.1989-07-14
TACCTILE PATIENT EXAMINATION GLOVES (K892958)Trans American Chemical Corp.1989-07-14
REMOVE ADHESIVE REMOVER (K893603)Smith & Nephew United, Inc.1989-07-14
PATIENT EXAMINATION GLOVES (NATURAL RUBBER) (K892680)Texla Industries Sdn. Bhd.1989-07-14
UHT PATIENT EXAMINATION GLOVES (LATEX) (K892578)United Health Technology, Inc.1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K891641)Global Latex Products Sdn Bhd1989-07-14
LATEX EXAMINATION GLOVES (K893594)Glovetex Industries1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K892273)Rouge Ent., Inc.1989-07-14
LATEX EXAMINATION GLOVES (K893901)Tillotson Corp.1989-07-14
DECUBITUS CARE PAD (K893969)Gulftrade Exim, Inc.1989-07-14
PATIENT EXAM GLOVES (MFG CHAOYANG SYNTHETIC FIBRE) (K892159)Sinochem (Usa), Inc.1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K892955)Awb Ent., Inc.1989-07-05
MEMORY CHAIN (K893654)American Orthodontics1989-06-23
LIFECELL RECOVERY CONTAINER (K893787)Baxter Healthcare Corp1989-06-23
MARLOW ANAL SPECULUM (K891352)Simpson/Basye, Inc.1989-06-23
PATIENT EXAMINATION GLOVES (LATEX) (K892566)Foodhandler, Inc.1989-06-23
COI 72 HR COLLAGEN SHIELD (K885015)Chiron Ophthalmics1989-06-23
BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER (K884927)Instrumentation Industries, Inc.1989-06-23
VICTOR MEDICAL OXYGEN THERAPY REGULATOR, MODIFIED (K891771)Thermadyne Holings Corp.1989-06-23
RADIOGRAPHIC CEILING TUBE SUPPORT CTS15 (K893653)Fischer Imaging Corp.1989-06-23
GENTLEHALER(R) (K892117)Schering Research1989-06-23
IMD 7GX (K885115)Medical Dental Technology Co.1989-06-23
PATIENT EXAMINATION GLOVE (K890931)Phutex Products Co., Ltd.1989-06-23
PATIENT EXAMINATION GLOVES (LATEX) (K892289)Ansell, Inc.1989-06-23
SERUMAX (AUTOMATED SERUM CENTRIFUGATION & STATION) (K893400)Medical Robotics1989-06-23
DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 (K892882)Nieusma R & D, Inc.1989-06-23
BREATHING MOUTHPIECE (K893791)Diemolding Corp.1989-06-23
TECNOL GAITERS PRODUCT NUMBER 47725-010 (K893702)Tecnol New Jersey Wound Care, Inc.1989-06-23
GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES) (K890782)Grieshaber & Co.1989-06-23
NASOGASTRIC PH SUCTION CATHETER, ST-5001 (K891410)Sensatronix Medical Systems, Inc.1989-06-23
DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET (K893140)Casco Standards1989-06-23
RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60 (K893652)Fischer Imaging Corp.1989-06-23
DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 (K892881)Nieusma R & D, Inc.1989-06-23
CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN (K893510)E.I. Dupont DE Nemours & Co., Inc.1989-06-23
CELLMATICS SHLAMYDIA DETECTION SYSTEM (K893669)Difco Laboratories, Inc.1989-06-23
PATIENT EXAMINATION GLOVES (LATEX) (K892266)Jenn Jiag Ent. Co., Ltd. C/O Rosyn Products, Inc.1989-06-23
DIASTEMA CLOSING KIT (K893542)American Orthodontics1989-06-23
SENSIMAT (K892657)Transworld X-Ray Corp.1989-06-23
DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET (K893141)Casco Standards1989-06-23
X-RING SEPARATORS (K893549)American Orthodontics1989-06-23
URIC ACID REAGENT (PROCEDURE NUMBER 686) (K893416)Sigma Chemical Co.1989-06-23
CLEARVIEW STREP A (K893422)Unipath , Ltd.1989-06-23
DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET (K893142)Casco Standards1989-06-23
BYRD EXTRACTOR SET (K893480)Medical Engineering and Development Institute1989-06-23
DESERET PRN ADAPTER (K893406)Deseret Medical, Inc.1989-06-22
TISSUE EMBEDDING MEDIUM (K893772)Stephens Scientific1989-06-22
LATEX EXAMINATION GLOVES, STYLE 510 LX (K891418)C & K Mfg. & Sales Co.1989-06-22
'EXMOOR' SINGLE USE SUCTION TUBE (K892504)Exmoor Plastics , Ltd.1989-06-22
BUD BRAND PATIENT EXAMINATION GLOVES (VINYL) (K891835)Associated Ent., Inc.1989-06-22
PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911 (K892803)United Hearing Systems, Inc.1989-06-22
WINFIELD LATEX EXAMINATION GLOVES (K891855)Winfield Co., Inc.1989-06-22
SURGICAL GLOVES (K885089)Wb Intl., Inc.1989-06-22
HPI NON STERILE EXAM GLOVES (K893018)Tillotson Corp.1989-06-22
FIBEROPTIC HEADLIGHT SYSTEM (K893458)Cuda Products Co.1989-06-22
TRU-TOUCH VINYL EXAM GLOVES (CANADA) (K891952)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-06-22
PATIENT EXAM GLOVES (MFG. NINGBO MEDICAL LATEX) (K892152)Sinochem (Usa), Inc.1989-06-22
PURAFLEX PATIENT EXAMINATION GLOVES (K892017)Medsi, Inc.1989-06-22
SINGLE USE VINYL EXAM GLOVES - COLOR CODED (K892976)Phoenix Medical Technology, Inc.1989-06-22
REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS (K892937)Dentsply Intl.1989-06-22
PATIENT EXAMINATION GLOVES (K892480)Foodhandler, Inc.1989-06-21
LATEX SURGICAL GLOVES (K893340)Kenmark Industrial Co., Ltd.1989-06-21
BACTON TM, BASIC TM, APO B REAGENT (K893884)Catachem, Inc.1989-06-21
PATIENT EXAMINATION GLOVES (LATEX) (K892309)Min an Chemical Industrial Co., Ltd.1989-06-21
SANITARY NAPKIN PADS (K890125)Landen Corp.1989-06-21
DELTA (TM) ROBOTIC PIPETTOR (K893031)Diagnostic Products Corp.1989-06-21
PATIENT EXAMINATION GLOVES (K890930)Thaima Products Co., Ltd.1989-06-21
BACTON TM, BASIC TM, APO A-I REAGENT (K893885)Catachem, Inc.1989-06-21
PATIENT EXAMINATION GLOVES (LATEX) (K892506)Universal Latex Products Co., Ltd.1989-06-21
MP TEST (K882596)Diatech Diagnostica , Ltd.1989-06-21
EBNA-CHECK(TM) TEST KIT (K891542)Diagnostic Technology, Inc.1989-06-20
RESUBMITTED EBV/IGM-CHECK TEST KIT (K890639)Diagnostic Technology, Inc.1989-06-20
SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY (K893605)Serono-Baker Diagnostics, Inc.1989-06-20
LATEX EXAMINATION GLOVES (K893268)Regulus Intl. Corp.1989-06-19
LOW POWDER SINGLE USE LATEX EXAM GLOVES (K892975)Phoenix Medical Technology, Inc.1989-06-19
WARDEN LATEX EXAMINATION GLOVES (K893179)Kuo Jun Ent. Co., Ltd.1989-06-19
PATIENT EXAMIAINATION GLOVES (LATEX) (K892247)Jiann FA Rubber Factory Co., Ltd.1989-06-19
CHOLESTEROL REAGENT SET (K893479)American Monitor Corp.1989-06-19
CHAMP-PAQ LATEX PATIENT EXAMINATION GLOVES (K893107)Winmed Instruments Mfg. Corp.1989-06-19
THE ROYAL GLOVES (PATIENT EXAM GLOVES) (K891958)Taizhu Latex Glove Factory , Ltd.1989-06-19
PATIENT EXAMINATION GLOVES (LATEX) (K891374)M.R.G. Industries Sdn. Bhd.1989-06-19
LATEX EXAMINATION GLOVES (K893015)Universal Gloves Private , Ltd.1989-06-19
REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171 (K893211)Helena Laboratories1989-06-19
QUALITEX LATEX EXAMINATION GLOVES (K892414)Agri-Bag Corp.1989-06-19
PATIENT EXAMINATION GLOVES (LATEX) (K892471)Tabri Gloves Sdn. Bhd.1989-06-19
PATIENT EXAMINATION GLOVES (LATEX) (K891702)Thai Nam Rubber Gloves Co., Ltd.1989-06-19
SAMBORD LATEX PATIENT EXAMINATION GLOVES (K891644)Polymint Industrial Co. , Ltd.1989-06-19
THE TONGUE CLEANER (K892388)Rajiv R. Shah1989-06-16
IMPLANT PARALLELING DEVICE (I.P.D.) (K890433)J.E. Josephson, D.M.D.1989-06-16
THE SMILE MACHINE (K891694)Brilliant Industries, Inc.1989-06-16
ALPHA MODEL I ITE HEARING AID (K890271)Alpha Instruments, Inc.1989-06-16
MICROTRAK EIA AUTOREADER (K891270)Syva Co.1989-06-16
STERILE IRRIGATION TRAYS (K890728)Cypress Medical Products, Ltd.1989-06-16
THE CEN-SLIDE(TM) CENTRIFUGE TUBE (K891604)Davstar California, Inc.1989-06-16
AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325 (K891922)American Research Products Co.1989-06-16
IRON SYSTEM PACK REAGENTS (K892838)Boehringer Mannheim Corp.1989-06-16
PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR (K893199)Allergan Medical Optics1989-06-16
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Every clearance here is in the API, with alerts when new ones post.