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

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RecordFirmDate
ACC.U.DIAL (K894423)Exocell, Inc.1989-12-27
MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT (K896641)Medix Biotech, Inc.1989-12-27
ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY (K896145)Serono-Baker Diagnostics, Inc.1989-12-27
MAGNET PAD (K896802)Westmark, Sterile Packing Systems, Inc. (Sps)1989-12-27
LATEX EXAMINATION GLOVES (K896003)Jiea Chao Ent. Co., Ltd.1989-12-27
NORMAL AND ABNORMAL CONTROL SERA (K895943)Sclavo, Inc.1989-12-27
CLOSED WOUND RESERVOIR (K896803)Westmark, Sterile Packing Systems, Inc. (Sps)1989-12-27
BANDAGE REMOVAL STRIP (K895884)Kut-Guard, Inc.1989-12-27
LATEX EXAMINATION GLOVES (K893461)Zhum Heng Development , Ltd.1989-12-27
CLINISTAT HDL CHOLESTEROL REAGENT TEST (K895139)Heraeus Kulzer, Inc.1989-12-27
MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP (K896589)Optik1989-12-27
MIKRO-LAVAGE-1 (K895755)Mikro-Tek Laboratories1989-12-27
BECKMAN MA MICROALBUMIN REAGENT KIT (K895883)Beckman Instruments, Inc.1989-12-27
RAMVAC DENTAL VACUUM SYSTEM (K895876)Ramvac Corp.1989-12-26
RAMCLEAN DENTAL VACUUM LINE CLEANER (K895877)Ramvac Corp.1989-12-26
PLASTIC SUNGLASSES (K896716)Bright Horizon Ent.1989-12-26
NON-PRESCRIPTION SUNGLASSES (K896768)Shairon Intl. Trade Co.1989-12-26
THE SMITHCOT (K896261)Ram Marketing, Inc.1989-12-22
DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL (K896511)E.I. Dupont DE Nemours & Co., Inc.1989-12-22
SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT (K895853)Sechrist Industries, Inc.1989-12-22
PATIENT EXAMINATION GLOVES (LATEX) (K892633)Gobo Intl.1989-12-21
ISODENT (K894058)Eurodent, Inc.1989-12-21
PATIENT EXAMINATION GLOVES (K893632)Pro Asia, Inc.1989-12-21
LATEX PATIENT EXAMINATION GLOVES (K895754)Frontline Latex Products Pvt. , Ltd.1989-12-21
PLASTIC TOOTH REINFORCEMENT KIT (K895758)Nanzee Dental Products1989-12-20
TOYOSUYA LATEX EXAMINATION GLOVES (K896489)Toyosuya Sdn Bhd1989-12-20
PATIENT EXAMINATION GLOVES (LATEX) (K892194)Pao Chen Industrial Co., Ltd.1989-12-20
LATEX PATIENT EXAMINATION GLOVES (K894900)Fujian Ming Sheng Chemistry1989-12-20
REVISED PATIENT EXAMINATION GLOVES (K896411)Pt. Trihasta Loka Persada1989-12-20
MICROMEDICS EAR, NOSE AND THROAT BURS (K895738)Micromedics, Inc.1989-12-19
LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II (K891691)Bio-Rad1989-12-19
COBAS READY (K896007)Roche Diagnostic Systems, Inc.1989-12-19
STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC' (K895807)Safeskin Corp.1989-12-18
JEDMED J-II CHAIR (K896275)Jedmed Instrument Co.1989-12-18
DIATECH IGM-MP TEST (K895276)Diatech Diagnostica , Ltd.1989-12-18
DIFCO OXIDASE DRYSLIDE (K896398)Difco Laboratories, Inc.1989-12-18
EBV-EA IFA KIT (K895652)Organon Teknika Treyburn1989-12-18
LYNX-HIGH SPEED HANDPIECE (K895736)Mti Precision Products1989-12-18
TWO MIRROR GONIO LENS (K895846)Ocular Instruments, Inc.1989-12-18
OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM) (K895408)Smith & Nephew United, Inc.1989-12-14
ACCUMED LATEX SURGICAL GLOVE (K893834)Accurate Medical Devices, Inc.1989-12-14
KEY VASCULAR BOOTIES (K896472)Key Surgical, Inc.1989-12-14
RADIATION PROTECTION APRON (K896289)Infab Corp.1989-12-14
MT96000 PAPER CHART RECORDER (K894736)Astro-Med, Inc.1989-12-13
CARDS O.S.(TM) STREP A (K896221)Pacific Biotech, Inc.1989-12-13
SPENCO BREAST FORMS (K896533)Spenco Medical Corp.1989-12-13
THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHION (K895444)Mcvicar Enterprises, Ltd.1989-12-13
AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 (K896270)Amersham Corp.1989-12-12
CHOLESTEROL, UNIVERSAL ET (K896073)Enzyme Technology, Inc.1989-12-12
GLOVE N GEL (K896306)Ems Medical, Inc.1989-12-11
EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) (K895708)Immuno Concepts, Inc.1989-12-11
PATIENT EXAMINATION GLOVES (LATEX) (K892091)Rising Crown Industries , Ltd.1989-12-11
PATIENT EXAMINATION GLOVE/MANUF. KUN SHAN FACTORY (K893513)Pioneer Sundries Products , Ltd.1989-12-11
WHITE MAGNOLIA DENUDATE LATEX EXAMINATION GLOVES (K896399)Prime Horizon, Inc.1989-12-11
PATIENT EXAMINATION GLOVES (LATEX) (K892636)P.T. Latexindo Parama1989-12-11
SPRING LATEX EXAMINATION GLOVES (K894213)Brandywine Surgical, Inc.1989-12-11
PATIENT EXAMINATION GLOVES (NON STERILE) (K895657)Ka Hung Development , Ltd.1989-12-11
LATEX EXAM GLOVES (MFG. SUPER GLOVE INDUSTRY CO.) (K895637)Transcontinental Fertilizer Co.1989-12-11
MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT (K895502)Microbio-Medics, Inc.1989-12-08
EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY) (K895707)Immuno Concepts, Inc.1989-12-08
BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG. (K895816)Bio-Rad1989-12-07
DISPOSABLE EXTERNAL CLAMPS (K896383)Galenica Enterprises, Inc.1989-12-06
PATIENT EXAMINATION GLOVES (K894308)Xing Huao Co. , Ltd.1989-12-05
LATEX EXAMINATION GLOVES (K895322)Advantage Resources1989-12-05
LATEX EXAMINATION GLOVES (K893357)M.M. Rubber Co. , Ltd.1989-12-05
URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS (K895821)Catachem, Inc.1989-12-05
TRU-TOUCH VINYL, STERILE (K892327)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-12-05
SYNCHRON CX SYSTEMS (LAP) REAGENT KIT (K895850)Beckman Instruments, Inc.1989-12-05
TAGUM LATEX EXAMINATION GLOVES (K892073)Tagum Rubber Industries, Ltd.1989-12-05
FEATHERWEIGHT VINYL, NON-STERILE EXAM GLOVES (K892328)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-12-05
NON-STERILE LATEX EXAMINATION GLOVES (K896220)Allstar Sdn. Bhd.1989-12-05
TRU-TOUCH VINYL, NON-STERILE (K891719)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-12-05
AQUATREX UNDERWATER TREADMILL SYSTEM (K895104)Edmonds Medical Systems1989-12-04
BREVET FLOSS PICK (AUTOCLAVE STERILIZER) (K895958)Brevet, Inc.1989-12-04
GNATHOMAT ARTICULATOR (K896131)Ivoclar North America, Inc.1989-12-04
ALCON FOLDING FORCEPS (K895434)Alcon Laboratories1989-12-04
OSBON PERSONAL LUBRICANT (K895406)Osbon Medical Systems, Ltd.1989-12-01
STRAWBERRY SCENTED LATEX EXAMINATION GLOVES (K896135)Arista Latindo Industrial Ltd. P.T1989-12-01
LATEX PATIENT EXAMINATION GLOVES (K895488)Zhong YI Latex Products Factory1989-12-01
PATIENT EXAMINATION GLOVES (LATEX) (K891493)Cinderella Ent. Co., Ltd.1989-12-01
PATIENT EXAMINATION GLOVES (K892279)Aek Rubber Product Sdn. Bhd.1989-12-01
OSBON PERSONAL LUBRICANT (K896207)Osbon Medical Systems, Ltd.1989-12-01
MODIFIED MODEL 535(TM) LUMINOMETER (K896117)Los Alamos Diagnostics1989-11-30
TON-SU'S VINYL EXAM GLOVES (K892584)Ton SU Co. , Ltd.1989-11-30
DEVILBISS MODEL 6300D (K896090)Devilbiss Health Care, Inc.1989-11-30
IMMUNOCARD STREP A TEST (K896109)Disease Detection International, Inc.1989-11-29
SURE & NATURAL(TM) UNSCENTED MENSTRUAL PAD (K895519)Personal Products Co.1989-11-29
KRONAMAX KUBE (K893903)Physicians Digital Co.1989-11-29
BREVET FLOSS PICK (COLD STERILIZATION FLUIDS) (K895959)Brevet, Inc.1989-11-29
ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION (K895103)Gen-Probe, Inc.1989-11-29
SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT (K895851)Beckman Instruments, Inc.1989-11-29
LATEX PATIENT EXAMINATION GLOVES (K894999)Pushpaman Processors, Div. Kanjur Bleaching Co. PV1989-11-28
LATEX PATIENT EXAMINATION GLOVES (K894713)Vailwood Products, L.P.1989-11-28
LONE STAR TRADING SURGICAL GLOVE (K896051)Lone Star Trading Pte. , Ltd.1989-11-28
LATEX PATIENT EXAMINATION GLOVES (K895491)Big Rubber Co., Ltd.1989-11-27
LATEX EXAMINATION GLOVES (K893366)Jinshan Caojing Latex Factory1989-11-27
NEW FREEDOM ANYDAY PANTILINERS (K894229)Kimberly-Clark Corp.1989-11-27
EXUSORB(TM) DRY/WET DRESSING (K896176)Controlled Therapeutics Corp.1989-11-24
MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50 (K896280)Micro-Aire Surgical Instruments, Inc.1989-11-22
STERILE HYPOALLERGENIC SURGEONS' GLOVES (K896165)Isratech Marketing Corp.1989-11-22
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