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

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RecordFirmDate
WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL (K901317)Widex Hearing Aid Co., Inc.1990-04-10
VECTRA(TM) (K901100)Optical Coating Laboratory, Inc.1990-04-10
HEARING AID (ALL-IN-THE-EAR) (K900968)Audiology of Tulsa, Inc.1990-04-10
MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE) (K901489)Eastmed Enterprises, Inc.1990-04-10
WIDEX MODEL Q9, BTE W/QUATRO REMOTE CONTROL (K901316)Widex Hearing Aid Co., Inc.1990-04-10
SPORTS PACK ELASTICS (K900578)Lancer Orthodontics, Inc.1990-04-10
ANESTHESIA WORKSTATION (K901474)Siemens Life Support Systems1990-04-10
UMBILICAL CORD BLOOD SAMPLING KIT (K900302)Ge Medical Systems Information Technologies1990-04-10
PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX (K901141)Baxter Healthcare Corp1990-04-09
MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC (K901107)United States Surgical, A Division of Tyco Healthc1990-04-09
PATIENT EXAMINATION GLOVES (K901479)Hexza World Trade Sdn. Bhd.1990-04-09
LATEX EXAMINATION GLOVES (K901148)Pt. Scitech Industries1990-04-09
AUTOMATED EIA MICROPLATE READER MODELS EL340/340I (K901059)Bio-Tek Instruments, Inc.1990-04-09
LATEX EXAMINATION GLOVES (K901136)Qilu (China) Good Luck Chemical Fibers, Inc.1990-04-09
AUTOMATED EIA MICROPLATE READER MODELS EL312/312I (K901027)Bio-Tek Instruments, Inc.1990-04-09
GUARDIAN FORCEP (K893636)Endo-Scientific, Inc.1990-04-09
PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO. (K900828)The Perkin-Elmer Corp.1990-04-09
SPAG PAK (K896608)Viratek, Inc.1990-04-09
ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE) (K895854)Acme-Monaco Corp.1990-04-09
DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER (K900093)Dentsply Intl.1990-04-06
POINT CHECKER COLOR STRIP THERMOMETER (K894893)Kyowa Medex Co., Ltd.1990-04-05
RX02 EMERGENCY MEDICAL OXYGEN (K895956)Progressive Medical Applications Corp.1990-04-05
PROTEX LATEX EXAMINATION GLOVE (K900790)Seyen Intl., Inc.1990-04-05
MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR (K900091)Onufryk Low Vision Ent.1990-04-04
SALIVA ABSORBER - DENTAL (K900631)Kab Gloves Unltd.1990-04-04
HEARING AID (ALL-IN-THE-EAR) (K900789)Solar Aid Corp.1990-04-04
INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA. (K897093)Microline Pentax, Inc.1990-04-04
DAHLBERG MODEL JH IN-THE-EAR HEARING INSTRUMENT (K900861)Miracle-Ear, Inc.1990-04-04
SURGEON'S GLOVES (K894087)Shangrila Latex Industries Pvt. , Ltd.1990-04-04
STEADFAST DENTURE ADHESIVE CREAM (K895818)Stiefel Research Institute, Inc.1990-04-03
SIGMA PROCEDURE NO. 735 (K897147)Sigma Diagnostics, Inc.1990-04-03
SNAP MYCOBACTERIA AVIUM COMPLEX (K900202)Syngene, Inc.1990-04-03
EXEC-WASH SOLID PHASE WASHING SYSTEM (K896631)Source Scientific Systems, Inc.1990-04-03
TECHNICON AXON SYSTEM REAGENT METHODS (K900905)Technicon Instruments Corp.1990-04-03
ENZYMUN TEST(R) INSULIN (K901135)Boehringer Mannheim Corp.1990-04-03
NOVAPATH MICROPLATE READER (K900776)Bio-Rad1990-04-03
ENZYMUN TEST(R) LH (K900779)Boehringer Mannheim Corp.1990-04-03
FG DIAMOND BURRS (K900089)Kab Gloves Unltd.1990-04-03
VITAL SURGICAL GLOVES (K901359)Mastervest Corp. Sdn Bhd.1990-04-03
SNAP M. TUBERCULOSIS COMPLEX (K900292)Syngene, Inc.1990-04-03
RADIOGRAPHIC INTENSIFYING SCREEN (K901014)Infab Corp.1990-04-02
LINGUAL SHEATH (K900184)Ormco Corp.1990-04-02
OXYGEN CATHETERS (K896731)Unoplast A/S1990-03-30
SUCTION CATHETER STRAIGHT/COUDE (K896730)Unoplast A/S1990-03-30
ENZYMUN TEST(R) PROLACTIN (K900695)Boehringer Mannheim Corp.1990-03-30
MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT (K897133)Transidyne General Corp.1990-03-30
PERCU-SET(TM) (K900021)E-Z-Em, Inc.1990-03-29
COULTER CHOLESTEROL REAGENT (K897162)Coulter Electronics, Inc.1990-03-29
COULTER MAGNESIUM REAGENT (K901265)Coulter Corp.1990-03-29
EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410 (K900850)Em Diagnostic Systems, Inc.1990-03-29
ELITECH GAMMA GT TEST KIT (K901090)Elite Technology, Inc.1990-03-29
PLAK TRAC POWERED TOOTHBRUSH (K896245)Windmere Corp.1990-03-28
CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY (K901279)Chatham Industries1990-03-28
RADIOGRAPHIC GRID (K901012)Infab Corp.1990-03-28
INTRAVENOUS STAND OR IV STAND (K900981)Travl-Med Infusion Device Transport System1990-03-27
PB PLUS LEAD LATEX GLOVES (K896759)Sistem Med-Pro (M) Sdn Bhd1990-03-27
REXTON PP 142, PP 142-L (K900636)Rexton, Inc.1990-03-27
EPVC PATIENT EXAMINATION GLOVE (K896938)United Orient, Inc.1990-03-27
PROTEX LATEX EXAMINATION GLOVES (K900933)Seyen Intl., Inc.1990-03-27
LATEX EXAM GLOVES (SHANGHAI RONGTONG LATEX GLOVES) (K900352)Sinochem (Usa), Inc.1990-03-27
URO TEX URINALS (K901000)Sierra Laboratories, Inc.1990-03-26
ANSELL CONFORM GREEN EXAMINATION GLOVES (K897081)Ansell, Inc.1990-03-26
PLATELIA TOXO IGG KIT (K894947)Kallestad Diag, A Div. of Erbamont, Inc.1990-03-23
PARAMAX ALANINE AMINOTRANSFERASE REAGENT (K901105)Baxter Healthcare Corp1990-03-23
TIP TOP(R) DISPENSER CAPS (K896670)Helena Laboratories1990-03-23
SURGEONS' GLOVES W/HYPOALLERGENICITY CLAIMS (K900985)Productes Del Latex, S.A.1990-03-20
IRON LIQUID STABLE REAGENT (K900902)Medical Analysis Systems, Inc.1990-03-19
HYCULT DIAMOND CORONARY BYPASS KNIFE (K900379)St. Jude Medical, Inc.1990-03-19
LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES (K893740)Reference Diagnostics, Inc.1990-03-19
NASAL E.T. TAPE (K900787)B&B Medical Technologies, Inc.1990-03-16
OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID (K897023)Audina Hearing Instrument1990-03-16
THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM (K897057)Thayer Medical Corp.1990-03-16
COMPUTERIZED FUNCTIONAL TESTING GAIT SYSTEM (K901069)Computerized Functional Testing Corp.1990-03-16
TCPM II TOURNIQUET CUFF PRESSURE MONITOR (K900104)Electromedics, Inc.1990-03-15
NON-ELECTRIC BIOPSY FORCEPS (K900065)Esco Precision, Inc.1990-03-15
ENZYMUN TEST(R) FSH (K900763)Boehringer Mannheim Corp.1990-03-15
CUSTOM TRAYS, KITS (K894610)L H M Ent., Inc.1990-03-15
NON-ELECTRIC BIOPSY FORCEPS (K900015)Esco Precision, Inc.1990-03-15
WIDEX HEARING AID MODEL ES 10 ASP T (K895982)Widex Hearing Aid Co., Inc.1990-03-15
CHEMO-TOUCH (K895195)Medical Resources, Ltd.1990-03-15
ANESTHESIA BREATHING CIRCUIT (K900594)Inhalation Plastics1990-03-15
WIDEX HEARING AID MODELS ES9T AND ES9H (K895981)Widex Hearing Aid Co., Inc.1990-03-15
DISPOSABLE PROPHY ANGLE AND ACCESSORIES (K897101)Dentsply Intl.1990-03-14
DAHLBERG MODEL JMS IN-THE-EAR HEARING INSTRUMENT (K900692)Miracle-Ear, Inc.1990-03-14
ONCOPROBE II SYSTEM (K896588)Care Wise Medical Products Corp.1990-03-14
MIRACLE EAR MODEL CK IN-THE-EAR HEARING AID (K900050)Miracle-Ear, Inc.1990-03-14
MCT COMPOSITE CHAIR (K900191)Medical Composite Technology, Inc.1990-03-14
HEARING AID (ALL-IN-THE-EAR) (K893004)Hearing Specialists of Nevada, Inc.1990-03-14
SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES (K900296)P.T. Latexindo Prautama1990-03-14
L.T.C. REPLACEMENT GASTROSTOMY TUBE (K896621)Intl. Medical Marketing, Inc.1990-03-13
ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG (K895468)Orgenics, Ltd.1990-03-13
RAPID NF SYSTEM (K900517)Innovative Diagnostic Systems, Inc.1990-03-13
DISPOSABLE CO2 ABSORBER/E (K897171)Gibeck, Inc.1990-03-13
MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM (K895915)Meridian Diagnostics, Inc.1990-03-12
NIKON MULTI-SPORT SUNGLASSES (K900090)Oculus America1990-03-12
MOBILIMB L4 LOWER LIMB CPM UNIT (K900795)Toronto Medical Corp.1990-03-12
LASER IMAGING WORK STATION (K897186)Innovision Medical, Inc.1990-03-12
POLY G PHYSIOLOGICAL DATA RECORDER (K897107)Cns, Inc.1990-03-12
MOBILIMB W1 WRIST CPM UNIT (K900466)Toronto Medical Corp.1990-03-12
THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM (K895479)Thayer Medical Corp.1990-03-09
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