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

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RecordFirmDate
FISHER PRICE SUNJAMMERS (K864399)Fisher Price1986-11-21
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN (K863860)Hybritech, Inc.1986-11-21
MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS (K864155)American Edwards Laboratories1986-11-20
EFTEKHAR RECHANNELIZATION DRILL GUIDE (K864314)The Anspach Effort, Inc.1986-11-19
MALE URINARY STRESS PAD* (K862877)Convatec, A Division of E.R. Squibb & Sons1986-11-19
LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS (K864384)Luxtec Corp.1986-11-19
FREE & ACTIVE(TM) ABSORBENT PADS (K862878)Convatec, A Division of E.R. Squibb & Sons1986-11-19
DR.500O OPERATING TABLE (K864295)Koken Mfg Company, Inc.1986-11-19
DR7700 OPERATING TABLE (K864325)Koken Mfg Company, Inc.1986-11-19
ZINETICS GASTROMETER (TM) (K862727)Zinetics Medical Technology Corp.1986-11-19
DENTAL PROPHY CUPS (VARIOUS TYPES) (K864059)Mission White Dental, Inc.1986-11-19
PROPHY CARE SOLUTION (K864215)Imd, Inc.1986-11-18
MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI) (K864307)Smith & Nephew, Inc.1986-11-18
DREAM DAM (K864096)Dental Dam, Inc.1986-11-18
LEUKOPLAST(R) POROUS AND SPORT TAPE (K864160)Beiersdorf, Inc.1986-11-17
GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN (K864193)Gaw, Inc.1986-11-17
LUXTEC LOUPES FOR SURGICAL VISION (K864386)Luxtec Corp.1986-11-17
MBK SURGEONS'(STERILE & NON-STERILE) SURG GLOVES (K864165)Mbk Medical Gloves Co., Ltd.1986-11-17
SURGICAL SKIN MARKER (K864371)Myocure, Inc.1986-11-17
C' AIRECUSH SEAT CUSHION (K864109)Medical Industries America, Inc.1986-11-14
MODEL Q55XT POWERED TREADMILL (K864013)Quinton, Inc.1986-11-14
PUSH CUSH (K864108)Medical Industries America, Inc.1986-11-14
FAULKNER FORCEPS (K864071)Staar Surgical Co.1986-11-13
MODEL AK 8184 CUSTOM-LOW-PROFILE HEARING AID (K864031)Int'L Hearing Aids, Inc.1986-11-13
MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT (K863756)Nova-Ventrx1986-11-13
LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES (K863874)Electro-Nucleonics Laboratories, Inc.1986-11-13
TERUMO SENSIBEAD(TM) EIA HLH KIT (K863929)Terumo Medical Corp.1986-11-13
UBI MAGIWEL(TM) FSH QUANTITATIVE (K864080)United Biotech, Inc.1986-11-13
KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER (K864037)Kera Corp.1986-11-13
MODEL AQ8181 CUSTOM-CANAL-IN-THE EAR HEARING AID (K864028)Int'L Hearing Aids, Inc.1986-11-13
AY8182 CUSTOM-SEMI CANAL-IN-THE-EAR HEARING AID (K864029)Int'L Hearing Aids, Inc.1986-11-13
SERUM VANCOMYCIN TOXICOLOGY CONTROL (K862419)Utak Laboratories, Inc.1986-11-13
RAPID ACID FAST STAIN (K864033)Sigma Diagnostics, Inc.1986-11-13
BENZODIAZEPINES TOXICOLOGY CONTROL (K862418)Utak Laboratories, Inc.1986-11-13
MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID (K864030)Int'L Hearing Aids, Inc.1986-11-13
ERYTHOCYTE CREATINE (K852767)Panmed, Inc.1986-11-13
RAPID IDENT. TEST FOR MYCOBACTERIUM AVIUM COMPLEX (K862613)Gen-Probe, Inc.1986-11-10
RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX (K862614)Gen-Probe, Inc.1986-11-10
OPTEC 1000 DMV (K863509)Stereo Optical Co., Inc.1986-11-10
EXETER OPERATING LOUPE (K863983)Exeter Instruments, Inc.1986-11-10
CUSTOM IN-THE-EAR (K863975)Gn Danavox, Inc.1986-11-07
TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER (K862919)Transpirator Technologics, Inc.1986-11-07
ADEC 1005-C CHAIR (K864072)Cherne Industries, Inc.1986-11-07
LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III (K864137)Bio-Rad1986-11-07
TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU (K864115)Cathaid, Inc.1986-11-07
NESBIT EVANS NURSING HOME BED (K864203)J. Nesbit Evans & Co.1986-11-07
PIASTRINIT (K863114)J. D. Assoc.1986-11-06
SERUM CLONAZEPAM TOXICOLOGY CONTROL (K862421)Utak Laboratories, Inc.1986-11-05
SMI MULTIPETTOR(TM) (K863887)American Dade1986-11-05
VMAX KINETIC MICROPLATE READER (K863802)Molecular Devices Corp.1986-11-05
WIDEX HEARING AID MODEL ES2 (K864097)Widex Hearing Aid Co., Inc.1986-11-05
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT (K863490)Ortho Diagnostic Systems, Inc.1986-11-05
OXOID SIGNAL BLOOD CULTURE SYSTEM (K862946)Oxoid U.S.A., Inc.1986-11-05
RANFAC CUT BIOPSY NEEDLE (K864139)Ranfac, Corp.1986-11-05
METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM (K863840)E.I. Dupont DE Nemours & Co., Inc.1986-11-05
INTEGRA, CUSTOM IN-THE-EAR HEARING AID (K864180)Bernafon, Inc.1986-11-05
HCG CONTROL KIT (K863744)Monoclonal Antibodies, Inc.1986-11-05
DIAGNOSTIC REAGENT PET-RPLA (K855235)Oxoid U.S.A., Inc.1986-11-04
DIAGNOSTIC REAGENT SET-RPLA (K855233)Oxoid U.S.A., Inc.1986-11-04
MARTIN MEDICAL PRO-SCOPE ANOSCOPE (K863273)Martin Medical1986-11-04
(ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE (K863385)Cook Urological, Inc.1986-11-04
GENTLE FEEL (K864176)Mali, Inc.1986-11-04
DIAGNOSTIC REAGENT TST-RPLA (K855236)Oxoid U.S.A., Inc.1986-11-04
DIAGNOSTIC REAGENT VET-RPLA (K855234)Oxoid U.S.A., Inc.1986-11-04
HITACHI HAND HELD MASSAGER A/C POWERED (K864088)Hitachi Sales Corporation of America1986-11-03
CALIBRATION GAS FOR SERVO GAS MONITOR 120 (K863675)Siemens Elema AB1986-11-03
UPDATED STERILE ENDOTRACHEAL BRUSHES (K863635)Biological & Environmental Control Laboratories1986-11-03
SR-IVOLEN TRAY MATERIAL (K863421)Ivoclar USA, Inc.1986-11-03
THORNTON TITANIUM FORCEPS (VARIOUS TYPES) (K863992)Keeler Instruments, Inc.1986-10-31
THORNTON TITANIUM SILVER SPATULA (K863990)Keeler Instruments, Inc.1986-10-31
THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) (K863989)Keeler Instruments, Inc.1986-10-31
PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS (K864003)Allergan, Inc.1986-10-31
TRYCOPHYTON AGARS (K864100)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-10-31
THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STAND (K863991)Keeler Instruments, Inc.1986-10-31
FIXATION INSTRUMENTS (K863727)Medical Technology Development Corp.1986-10-31
VTS REPORTER OR VTS LINK (K863993)Sensory Aids Corp.1986-10-31
THE ERGOSYSTEM CHAIR (K863728)Charles D. Bell, Inc.1986-10-31
CATARACT DIAMOND KNIFE (K863725)Medical Technology Development Corp.1986-10-31
THORTON TITANIUM HOOK ANGLED RIGHT (K863988)Keeler Instruments, Inc.1986-10-31
VIEWSCAN (K863994)Sensory Aids Corp.1986-10-31
CANDIDA BROM CRESOL GREEN AGAR (K864077)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-10-31
LATEX SURGICAL GLOVES (K864064)Futuremed Div. of Future Impex Corp.1986-10-30
GLASS MOUTH MIRRORS, REUSABLE (K863767)The Medical Group, Inc.1986-10-30
EVACUATOR TIPS (K863769)The Medical Group, Inc.1986-10-30
NONCONDUCTIVE SHOE COVER (K864026)Kimberly-Clark Corp.1986-10-30
DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLY (K863766)The Medical Group, Inc.1986-10-30
NEEDLE NOSE PLIERS (K864019)Med-Tool, Inc.1986-10-30
COLTENE JET-MIXER (K863998)Coltene, Inc.1986-10-30
GUTTA PERCHA POINTS (K863638)Endodent, Inc.1986-10-30
SCHEIN BLEACHING UNIT (K862385)Henry Schein, Inc.1986-10-30
SHINER STRESS DIRECTING ATTACHMENT (K863243)Js & R - R & D Co.1986-10-30
GUTTA PERCHA (K863411)Endodent, Inc.1986-10-30
FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000 (K863753)Foundations Plus, Inc.1986-10-30
THE FIAX 5000 FLUOROMETER (K863434)Whittaker Bioproducts, Inc.1986-10-29
TISSUE CULTURE FLASK (K864021)Fenwal Laboratories1986-10-29
URIC ACID TEST (K864119)U. S. Diagnostics, Inc.1986-10-29
SERACON CT REFERENCE (K863648)Bhp Diagnostix, Inc.1986-10-29
THE WELLCOME ROTAVIRUS LATEX TEST ZL40 (K861634)Wellcome Diagnostics1986-10-29
LOMBARD DOWELL AGAR BASE (K864014)Gibco Laboratories Life Technologies, Inc.1986-10-29
EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95 (K863660)Em Diagnostic Systems, Inc.1986-10-29
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