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

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RecordFirmDate
SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM (K862024)Ocular Instruments, Inc.1986-07-11
COTTON FILLED GAUZE SPONGES 2 X 2 (K861727)Cross Country Paper Products Corp.1986-07-10
HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA) (K862555)Viromed Laboratories, Inc.1986-07-10
MASTER KIT B (K861142)Pro-Lab, Inc.1986-07-10
# 10099/10225/10235/10275/10525/10625/10715/10125 (K862193)U.O. Equipment Co.1986-07-09
KING DIAGNOSTICS URIC ACID TEST (K862208)King Diagnostics, Inc.1986-07-08
ORTHOBLEND POWERED BONE MILL (K860356)Zimmer, Inc.1986-07-08
TDX REA LACTIC ACID (K861741)Abbott Laboratories1986-07-07
VANILMANDELIC ACID (VMA) REAGENT SET (K861962)Sterling Diagnostics, Inc.1986-07-07
V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II (K861756)Texas Immunology, Inc.1986-07-07
LAURIER SAFETY LONG SANITARY NAPKIN (MODIFICATION) (K862271)Kao Corp.1986-07-07
ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM (K861773)Zygotek Systems, Inc.1986-07-07
NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE (K862365)Swemed Laboratories, Inc.1986-07-07
HBDH (OPTIMIZED) REAGENT (K862319)Sigma Chemical Co.1986-07-07
CIRCUIT ANES. BREATHING & COMPONENTS (K862003)Vital Signs, Inc.1986-07-07
LAURIER OVERNIGHT SANITARY NAPKIN (MODIFICATION) (K862270)Kao Corp.1986-07-07
MODIFIED COTROPIN RADIOIMMUNOASSAY KIT (K862180)Clinetics Corp.1986-07-07
THE D & C PAD-SAC (K862297)Nu-Gyn-Tek, Inc.1986-07-07
BIOTIS DECARBOXYLASE MEDIA, ARGININE (K862396)Otisville Biotech, Inc.1986-07-03
BIOTIS BORDET GENGOU AGAR (K862390)Otisville Biotech, Inc.1986-07-03
BIOTIS ACETAMIDE AGAR (K862389)Otisville Biotech, Inc.1986-07-03
BIOTIS SXT AGAR (K862399)Otisville Biotech, Inc.1986-07-03
BIOTIS DECARBOXYLASE MEDIA, BASE (K862395)Otisville Biotech, Inc.1986-07-03
BIOTIS DECARBOXYLASE MEDIA, ORNITHINE (K862398)Otisville Biotech, Inc.1986-07-03
BIOTIS DECARBOXYLASE MEDIA, LYSINE (K862397)Otisville Biotech, Inc.1986-07-03
BIOTIS KV LAKED BLOOD AGAR (K862400)Otisville Biotech, Inc.1986-07-03
NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS (K860472)Nuclear Diagnostics, Inc.1986-07-03
GEN-PROBE MYCOPLASMA PNEUMONIA RAPID DETECT SYSTEM (K860574)Gen-Probe, Inc.1986-07-03
BIOTIS LITMUS MILK (K862393)Otisville Biotech, Inc.1986-07-03
BIOTIS MITIS SALIVARIUS (K862394)Otisville Biotech, Inc.1986-07-03
BIOTIS TCBS AGAR (K862388)Otisville Biotech, Inc.1986-07-03
BIOTIS HAEMOPHILUS IDENTIFICATION QUAD (K862387)Otisville Biotech, Inc.1986-07-03
BIOTIS DESOXYCHOLATE AGAR (K862391)Otisville Biotech, Inc.1986-07-03
BIOTIS MOTILITY TEST MEDIUM (K862392)Otisville Biotech, Inc.1986-07-03
SINGLE-USE PATIENT UNDERPAD (K862348)Procter & Gamble Mfg. Co.1986-07-02
CLINIFACTS 200 DATA MANAGEMENT SYSTEM (K861778)Miles Laboratories, Inc.1986-07-02
MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM (K862425)Gibco Laboratories Life Technologies, Inc.1986-07-02
GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM (K860782)Gen-Probe, Inc.1986-07-02
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/ASSAYED (K860999)Ciba Corning Diagnostics Corp.1986-07-02
RAMP PROGESTURINE PDG ASSAY--48 TEST KIT (K860924)Monoclonal Antibodies, Inc.1986-07-02
FUJITSU MALLEABLE - TIP BRAIN SPATULA (K862331)Downs Surgical , Ltd.1986-07-01
INORGANIC PHOSPHORUS PROCEDURE (K861661)Data Medical Associates, Inc.1986-07-01
ROTAVIRUS LATEX AGGLUTINATION ASSAY (K861172)Bartels Immunodiagnostic Supplies, Inc.1986-07-01
UNISKAN II (K861897)Flow Laboratories, Inc.1986-07-01
TRIGLYCERIDE (TRINDER) PROCEDURE (K861670)Data Medical Associates, Inc.1986-07-01
TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM (K862415)Parexel Intl. Corp.1986-07-01
SOMAS LIQUID URINE CONTROL (K862179)Somas Medical Industries, Inc.1986-07-01
RAPID BACTERIURIA SCREEN (RBS) (K862195)New Horizons Diagnostics Co.1986-06-30
HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER (K862020)Intertech/Ohio1986-06-30
LYOFOAM WOUND DRESSINGS (K860085)Acme United Corp.1986-06-27
SUCROSEP HUMAN PROLACTIN (HPR) IRMA (K861271)Boots-Celltech Diagnostics, Inc.1986-06-27
TWIN TRIGLYCERIDES GPO/CHOLESTEROL (K861793)Boehringer Mannheim Corp.1986-06-27
DERMISTRIP (K861972)Kells Medical, Inc.1986-06-27
PROGROUP (TM) AUTOMATED LIQUID HANDLING SYSTEM (K861580)Cetus Corp.1986-06-27
ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE (K861361)Serono Diagnostics, Inc.1986-06-27
RAICHEM CHOLINESTERASE REAGENT (K862168)Reagents Applications, Inc.1986-06-27
WORTHINGTON HDL PRECIPITATING REAGENT SET (K861926)Cooper Biomedical, Inc.1986-06-27
TRIGLYCERIDES GPO-TRINDER (K861635)Catachem, Inc.1986-06-27
MODEL CA, HEARING AID (K862095)Fine-Tune1986-06-26
HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT (K861846)Solar Dental Co., Inc.1986-06-26
SCHERER PORTABLE TOOTH POLISHER (K860264)Scherer Laboratories, Inc.1986-06-26
HYGEIA RAPID STREP A TEST (K862133)Hygeia Sciences1986-06-25
ALT (SGPT) REAGENT SET (UV RATE) (K862209)Sterling Diagnostics, Inc.1986-06-25
ALT-30, 60 AND 100 (K861366)Dimension Diagnostics1986-06-25
DELFIA (TM) HFSH KIT (K862043)Lkb Instruments, Inc.1986-06-24
MODEL HP HEARING AID (K862036)Fine-Tune1986-06-23
MODEL UC SPECTRUM IN-THE-CANAL HEARING AID (K862104)Miracle-Ear/Dahlberg, Inc.1986-06-23
MODEL UC IN-THE-CANAL HEARING AID (K862103)Miracle-Ear/Dahlberg, Inc.1986-06-23
MODEL PC HEARING AID (K861939)Fine-Tune1986-06-23
DAHLBERG MODEL EE BEHIND-THE-EAR HEARING AID (K862099)Miracle-Ear/Dahlberg, Inc.1986-06-23
UCS-2, ULTRASONIC CLEANING SOLUTION (K861147)Keymed, Inc.1986-06-23
LIFESOUND CUSTOM ITE (K862050)Lifesounds, Inc.1986-06-23
MODEL KM IN-THE-CANAL HEARING AID (K862102)Miracle-Ear/Dahlberg, Inc.1986-06-23
MODEL UM IN-THE-CANAL HEARING AID (K862101)Miracle-Ear/Dahlberg, Inc.1986-06-23
MODEL ED BEHIND-THE-EAR HEARING AID (K862100)Miracle-Ear/Dahlberg, Inc.1986-06-23
HCI MECONIUM ASPIRATOR (K862132)Hospital Concepts, Inc.1986-06-19
MODEL RS-3 RADIOGRAPHIC STAND (K861995)Medicor USA , Ltd.1986-06-19
WEC-WASH, CATALOG NO. 850-115 (K861592)Palmetto Chemical & Supply Co., Inc.1986-06-17
GOTTEX SUNGLASSES (K861021)Private Eyes Sunglass Corp.1986-06-17
SOFT LENS FOLDER (K861990)Staar Surgical Co.1986-06-17
MICRO THIN* PARAFFIN (K862223)Richard-Allan Medical Ind., Inc.1986-06-17
WECK INSTRUMENT CLEANER, CAT. NO. 850-103 (K861588)Palmetto Chemical & Supply Co., Inc.1986-06-17
WEC-KLEEN, CATALOG N. 850-102 (K861590)Palmetto Chemical & Supply Co., Inc.1986-06-17
DELFIA (TM) HUMAN PROLACTIN (K861542)Lkb Instruments, Inc.1986-06-17
RESUSIKIT (K861482)Begley Enterprises, Inc.1986-06-17
INTER-SHARP (K862070)Intermedics Intraocular, Inc.1986-06-17
MULTI-4 CO-OXIMETER CONTROL (K861901)Allied Instrumentation Laboratory1986-06-17
WM10, WM20, WM30 POWER MASSAGER (K862041)Associated Mills, Inc.1986-06-17
CHILDREN'S SUNGLASSES (K861927)Jestroy, Ltd.1986-06-17
COLOPLAST CONVEX RING (K861070)Coloplast A/S1986-06-16
TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD (K862152)Travenol Laboratories, S.A.1986-06-16
VENESECTION EQUIPMENT STORAGE TRAY (K862154)Rmp Co.1986-06-16
BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE (K862123)Marion Laboratories, Inc.1986-06-16
HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET (K861855)Sterling Diagnostics, Inc.1986-06-16
DOCUMENT ENZYME LINEARITY TEST SETS (K861506)Casco Standards1986-06-13
MEDTECH C.P.R. MASK (K862199)The Medtech Group, Inc.1986-06-13
EMIT CAFFEINE CONTROL (K861511)Syva / A Syntex Co.1986-06-13
URIC ACID PROCEDURE (K861660)Data Medical Associates, Inc.1986-06-13
CHOLESTEROL PROCEDURE (K861659)Data Medical Associates, Inc.1986-06-13
MICROSCOPE SLIDES (K862112)Abco Dealers, Inc.1986-06-13
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