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

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RecordFirmDate
EIA FOR DETECTION OF ANTIBODIES H. PYLORI (K905409)E-Z-Em, Inc.1991-06-10
EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST (K911569)Ortho Diagnostic Systems, Inc.1991-06-10
SYVA EDMS (K912055)Syva Co.1991-06-10
DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL (K911854)Baxter Healthcare Corp1991-06-10
OP-D-OP VISOR SHIELDS (K911742)Op-D-Op, Inc.1991-06-07
PHILIPS M30 IN-THE-EAR HEARING AID (K912339)Philips Hearing Instruments Co.1991-06-07
COMFOR-BOARD (K910880)Medway1991-06-06
PALAVIT GLC (K904928)Kulzer, Inc.1991-06-06
ORIGINALS (K911277)Face 2 Face Corp.1991-06-06
VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS (K895920)Vitaphore Corp.1991-06-06
SELECTOR MD (50KW AND 80 KW) (K910650)Hofmann-Nagel Medical Systems, Inc.1991-06-06
HYDENT (K911259)Pascal Co., Inc.1991-06-06
PALAVIT L (K905058)Kulzer, Inc.1991-06-06
MARK 5 ROBOTIC PIPETTOR (K912228)Diagnostic Products Corp.1991-06-06
STABIDENT LOCAL ANESTHESIA SYSTEM (K910446)Fairfax Dental, Inc.1991-06-03
DASH MEDICAL GLOVES (K912038)Safehealth Labs1991-06-03
SPENCIO SKIN GUARD KIT (K910927)Spenco Medical Corp.1991-06-03
IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS (K911163)Imagyn Medical, Inc.1991-06-03
NASCOR OXYDOME (K905627)Nascor Pty. , Ltd.1991-06-03
MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING (K905464)Angiosystems, Inc.1991-05-31
DIRECTIGEN 1-2-3 PREGNANCY CONTROLS (K911664)Quidel Corp.1991-05-31
T600 TREADMILL (K910867)Siemens Burdick, Inc.1991-05-31
SPLINTER TWEEZERS (K910570)Solan Scissors Sales1991-05-31
ZERO-G(TM) GEL/FOAM MATTRESS TOPPER (K911843)Steridyne Corp.1991-05-30
BARD SINGULAR BIOPSY FORCEPS (K912214)C.R. Bard, Inc.1991-05-30
RIVER MEDICAL MICRODRILL SYSTEM (K905437)River Medical, Inc.1991-05-30
PULPDENT DIAMOND POLISH (K911284)Pulpdent Corp.1991-05-30
FACEPLATE ITE HEARING AID MODEL 28A (K910901)Telex Communications, Inc.1991-05-30
FACEPLATE ITE HEARING AID MODEL TCA (K910900)Telex Communications, Inc.1991-05-30
MEDTRACK TREADMILL (K911751)Quinton, Inc.1991-05-29
HYPERGEL PROTECTIVE WOUND GEL (K905439)Scott Health Care1991-05-29
MEDI GUARD PILLOWCASE (K911948)Sancella, Inc.1991-05-28
MEDI GUARD UNDERPAD (K911952)Sancella, Inc.1991-05-28
MX CYCLER (K905071)Dakmed, Inc.1991-05-28
MEDI GUARD SHEETS/UNDERLAYS (K911953)Sancella, Inc.1991-05-28
WIDEX MODEL QX IN-THE-EAR HEARING AID (K912169)Widex Hearing Aid Co., Inc.1991-05-28
SR1 ESTRADIOL ENZYME IMMUNOASSAY (K911396)Serono-Baker Diagnostics, Inc.1991-05-28
TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE (K911438)Bio-Tek Instruments, Inc.1991-05-23
SMALL INSTRUMENT STERILIZATION/BUR BOX (K910794)Brevet, Inc.1991-05-23
MILENIA PROGESTERONE (K911512)Diagnostic Products Corp.1991-05-22
ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION (K911724)E.I. Dupont DE Nemours & Co., Inc.1991-05-22
NEBU-SOL METERED DOSE DISPENSER (TM) (K910239)Dey Laboratories, Inc.1991-05-22
HDL CHOLESTEROL REAGENT (K911406)Genzyme Corp.1991-05-22
OSMOMETER MODEL 2400 (K911092)Advanced Instruments, Inc.1991-05-22
CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE (K911755)Bionostics, Inc.1991-05-22
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY (K911062)Storz Instrument Co.1991-05-22
SUNGLASSES-NONPRESCRIPTION INCLUDING PHOTOSEN. (K911766)Gall'S, Inc.1991-05-22
TARGET ASO TEST (K910073)Texas Immunology, Inc.1991-05-21
JACKSON MULTIPURPOSE OPERATING TABLE (K910736)Orthopedic Systems, Inc.1991-05-21
MEDI GUARD DRAPES (K911950)Sancella, Inc.1991-05-21
VILLAN (VIDEO LIFT LINK ANALYSIS) (K910712)Physio Systems, Inc.1991-05-21
REDDICK TROCAR AND CANNULA (K911601)Ideal Medical, Inc.1991-05-21
MUCAID (K910909)Vygon Corp.1991-05-20
MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING (K910908)Vygon Corp.1991-05-20
CHAMPION, BEHIND-THE-EAR HEARING AID (K911705)Electone, Inc.1991-05-17
AUGUSTINE STYLET (K910659)Augustine Medical, Inc.1991-05-17
ZINETICS INTERNAL REFERENCE PROBE (K910694)Zinetics Medical, Inc.1991-05-17
STOCK CANAL, IN-THE-EAR HEARING AID (K911709)Electone, Inc.1991-05-17
LATEX EXAM GLOVES-POWDER FREE (K910949)Zhongmin (Fujian) Machinery & Electrical Equipment1991-05-17
MODEL 800, BEHIND-THE-EAR HEARING AID (K911706)Electone, Inc.1991-05-17
REGAL, BEHIND-THE-EAR HEARING AID (K911707)Electone, Inc.1991-05-17
MODEL E-50, IN-THE-EAR HEARING AID (K911708)Electone, Inc.1991-05-17
NATIVE PROTHROMBIN ANTIGEN EIA (K910617)Organon Teknika Corp.1991-05-15
#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES (K910781)Midmark Corp.1991-05-15
PROTEKT GLOVES (K910920)Intermedics Orthopedics1991-05-15
G-FLOSS & G-FLOSS II (K911701)Implant Innovations International, Inc.1991-05-15
29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM (K911068)Micro Motors, Inc.1991-05-15
CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION (K911578)Cholestech Corp.1991-05-15
PULPDENT PIC N STIC (K911281)Pulpdent Corp.1991-05-15
BUFFING FLOSS (K911470)Lamar Industries1991-05-15
STRATUS(R) AUTOMATED SAMPLE HANDLER (K911712)Baxter Healthcare Corp1991-05-15
SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR (K911072)A & F Products1991-05-15
SONOPAK/QS, SONOPAK (K905657)Bioresearch1991-05-15
HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED (K911803)Hichem Diagnostics1991-05-15
PATHFINDER (K910601)Nurion Industries1991-05-14
PRECISION GLIDE - ENHANCED SURGICAL BLADE (K911913)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-05-13
QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER (K911369)Deroyal Industries, Inc.1991-05-13
MODIFIED AEROCHAMBER WITH MASK (K900576)Monaghan Medical Corp.1991-05-13
BACTI-SWAB (K910180)Remel Co.1991-05-10
DOCUMENT REFLECTANCE II LINEARITY TEST SET (K910440)Casco Standards1991-05-10
GLOVE-N-GEL AMNIOTOMY KIT (K910518)Epcom Medical Systems, Inc.1991-05-09
LIFELINER SURGICAL GLOVE (K910941)Depuy-Raynham1991-05-09
PERRY(R) ENCORE CHEMOTHERAPY GLOVE (K911633)Smith & Nephew Perry1991-05-09
NHS 2009SP HEARING AID (K911174)Magnatone Hearing Aid Corp.1991-05-09
RAPID IMMOBILIZATION DEVICE OR R.I.D. SYSTEM (K904237)Innovative Medical Technologies, Inc.1991-05-09
NNHS 2050 SERIES (2055W-2054PP) HEARING AIDS (K911182)Magnatone Hearing Aid Corp.1991-05-09
QUALTEX SUTURE BOOTIES (K911895)Deroyal Industries, Inc.1991-05-08
TRO-GARD (K910678)Conmedcorp1991-05-08
QUALTEX SKIN STAPLE EXTRACTOR (K911204)Deroyal Industries, Inc.1991-05-08
DISPOSABLE ANESTHESIA BREATHING CIRCUIT (K910896)Specialty Packaging Producs, Inc.1991-05-08
STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELS (K911579)Starkey Laboratories, Inc.1991-05-07
ROCHE REAGENT FOR APOLIPOPROTEIN B (K910552)Roche Diagnostic Systems, Inc.1991-05-07
QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR (K905049)Quidel Corp.1991-05-07
ROCHE REAGENT FOR APOLIPOPROTEIN A-1 (K910551)Roche Diagnostic Systems, Inc.1991-05-07
PYLORI STAT TEST KIT (K904738)Whittaker Bioproducts, Inc.1991-05-07
PYLORI-G FIAX TEST KIT (K905468)Whittaker Bioproducts, Inc.1991-05-07
SPECTACLE FRAME (K911332)Australian Optical Co., Inc.1991-05-06
OPTHLAMIC FRAMES (K910951)United Optical, Spa1991-05-06
ALADAN LATEX MEDICAL GLOVE (K911774)Aladan Corp.1991-05-03
MENTOR LUBRICATING JELLY (K910790)Mentor Corp.1991-05-03
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Every clearance here is in the API, with alerts when new ones post.