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

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RecordFirmDate
ROCHE REAGENT FOR ALT (K843111)Roche Diagnostic Systems, Inc.1984-10-05
VICO MICRO SURGICAL INSTRUMENTS (K843592)Visitec Co.1984-10-05
VISION TESTER (K843042)Stereo Optical Co., Inc.1984-10-05
FRAME SPECTACLE (K843123)Vision Industries Corp.1984-10-05
ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC. (K843434)Iso-Data, Inc.1984-10-05
PERSPECTIVE CHEMICAL ANALYZER (K843610)American Monitor Corp.1984-10-05
BREATHABLE MINI-SHIELD-PRIVATE LABEL (K843602)I.C.D. Industries, Inc.1984-10-05
RING SUPPORTED TREPHINE FOR CORNEA TRANS (K843048)Precision Instruments, Inc.1984-10-05
SAFE & SOFT PANTY SHIELDS (K842838)Ipco Corp.1984-10-05
CONCEPT FIBER OPTIC CANALICULUS INTUBA (K843491)Concept, Inc.1984-10-05
EMIT 700 CANNABINOID CONTROL SET (K843419)Syva Co.1984-10-05
KOVA TROL I,II, III HUMAN URINE-DRIED (K843565)Icl Scientific1984-10-05
ORTHO* RSV ANTIGEN ELISA TEST SYS (K842047)Ortho Diagnostic Systems, Inc.1984-10-05
CORNEAL LIGHT SHIELD (K840834)Gabl, Inc.1984-10-05
TUBE-STAT (K843490)Concept, Inc.1984-10-04
LINDER NASOPHARYNGEAL AIRWAY (K843524)Polamedco, Inc.1984-10-04
COTTON TIPPED APPLICATORS, SINGLE (K843720)Abco Dealers, Inc.1984-10-04
NEOMYCIN BLOOD AGAR (K843492)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-10-02
GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 (K843427)Accra Laboratories, Inc.1984-10-02
HARRIS HEMATOXYLIN, MERCURY FREE, ACID (K843425)Accra Laboratories, Inc.1984-10-02
DIFFERENTIATION DISKS NITRATE (K843521)Difco Laboratories, Inc.1984-10-02
AMIZYME-C TRACHOMATIS TEST KIT (K842525)Amico Lab, Inc.1984-10-01
FORMALIN BUFFERED (K842982)Reagent Laboratory, Inc.1984-10-01
BACTO STAPHYLOCOCCUS LATEX TEST (K843560)Difco Laboratories, Inc.1984-10-01
VON WILLEBRAND FACTOR ANTIGEN SCREEN (K842537)American Dade1984-10-01
RIM-UREA (K843571)Austin Biological Laboratories1984-10-01
ANTI-CHLAMYDIA TRACHOMATIS KIT (K842658)Amico Lab, Inc.1984-10-01
SUR-FIT IRRIGATION ADAPTER FACEPLATE (K842398)Convatec, A Division of E.R. Squibb & Sons1984-10-01
WELLINGTON HOSPITAL PATTERN SELF-RETAIN (K843388)Downs Surgical , Ltd.1984-10-01
HYCEL DILUTOR, VARIOUS MODELS/MULTI (K842747)R&D Systems, Inc.1984-10-01
FETAL BOVINE SERUM, F4884 STERILE GROWT (K843629)Sigma Chemical Co.1984-10-01
FIAX 420 DILUTOR (K843621)Intl. Diagnostic Technology1984-09-28
VMA ASSAY KIT (K843379)Diagnostic Chemicals, Ltd. (Usa)1984-09-28
MATCHED COMPONENT SET FOR RADIOIMMUNO- (K843635)Cambridge Medical Technology1984-09-28
PDA CHOLESTEROL (K843510)Abbott Laboratories1984-09-28
QUALIFY I & II AMER. MONITOR 2009 & 2010 (K843611)American Monitor Corp.1984-09-28
PRECISET AMMONIA (K843569)Boehringer Mannheim Corp.1984-09-28
ENZYMATIC CHOLESTEROL KIT (K843222)Livonia Diagnostics, Inc.1984-09-28
EMIT 700 CONTROL SET B (K843508)Syva Co.1984-09-28
EOSIN Y 1% ALCOHOLIC (K843426)Accra Laboratories, Inc.1984-09-27
RELIANCE TREATMENT CABINET (K843046)F. & F. Koenigkramer1984-09-27
STABILIZING RETAINER (K843143)Dental Advancements, Inc.1984-09-27
ANDROSTENEDIONE BY RIA (K842960)Radioassay Systems Laboratories, Inc.1984-09-27
INSTRUMENTS FOR MICRO ANASTOMOSIS (K843100)Downs Surgical , Ltd.1984-09-27
DENTAL CHAIR (K843436)Swedish Dental Products, Inc.1984-09-27
FLEXI-POST (K843018)Essential Dental Systems, Inc.1984-09-27
GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK (K843341)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-09-27
BIOFIX (K843428)Accra Laboratories, Inc.1984-09-27
MEDICALEX (K833377)Medicalex1984-09-27
URINE TRANSPORT KIT (K843359)Applied Polytechnology, Inc.1984-09-27
ISO-DATA IMMUNOASSAY NETWORK SYSTEM (K843365)Iso-Data, Inc.1984-09-27
C-SECTION TRAY (K842627)Deroyal Industries, Inc.1984-09-26
ELECTRONIC EPILATOR TS-1 (K843063)R. A. Fischer Co. Corp.1984-09-26
ULTRAVIOLET-VISIBLE SPECTROPHOTOMETER (K843460)Varian Assoc., Inc.1984-09-26
TRIGLYCERIDES GPO REAGENT (K843552)Bio-Rad1984-09-26
BRIMFIELD CANNULATED GRASPING HOOKS (K843136)Brimfield Scientific Instruments1984-09-25
PERRY DERMAGUARD SURGICAL GLOVES (K843125)Perry, Div.1984-09-25
VENI-SHIELD (K842999)U.S. Mfg. & Management, Inc.1984-09-24
PHARMA-PLAST PETRI DISH (K843483)Zimmar Consulting , Ltd.1984-09-21
PRECISION DISPENSER (K843606)Medical Technomics, Ltd.1984-09-21
MINICAPS (K843361)Medical Technomics, Ltd.1984-09-21
LABOPETTOR (K843607)Medical Technomics, Ltd.1984-09-21
DRABKIN REAGENT (K842931)E K Ind., Inc.1984-09-21
RINGCAPS (K843362)Medical Technomics, Ltd.1984-09-21
FRONT RADIUS CUTTER (K841620)Plastafil, Inc.1984-09-20
BACK RADIUS CUTTER (K841621)Plastafil, Inc.1984-09-20
ECLIPSE HEART SUPPORT FOR CORONARY ARTER (K843216)Biotrac Laboratories1984-09-20
NU-THOR THORACOSTOMY KIT (K842666)Intl. Medical Devices , Ltd.1984-09-20
SYSTEMATE GPT 67209 (K843334)Em Diagnostic Systems, Inc.1984-09-20
UNILET LANCET (K842517)Ulster Scientific, Inc.1984-09-20
LOW PRESSURE ALARM FOR OXYGEN CYLINDER (K843212)Hospitak, Inc.1984-09-19
RICHARDS INTRA-ARTICULAR SHAVER MOTOR (K842475)Richards Medical Co., Inc.1984-09-17
FIAX 100 FLUOROMETER (K843356)Intl. Diagnostic Technology1984-09-17
T.I.M.E. DISPENSER (K843272)Dynatech Laboratories, Inc.1984-09-14
CORNING HIGH RESOLUTION PROTEIN ELECTRO (K843397)Corning Medical & Scientific1984-09-14
PROLACTIN IRMA (K842478)Euro-Diagnostics BV1984-09-14
SYSTEMATE CHOLESTEROL 67222 (K843327)Em Diagnostic Systems, Inc.1984-09-14
STREP SELECTIVE II (K843193)Remel Co.1984-09-14
ACETIC ACID 1% V/V (K842938)E K Ind., Inc.1984-09-14
TECHNICON RA-1000 SYS IRON FOR SERUM (K843255)Technicon Instruments Corp.1984-09-14
ROTALEX LATEX AGGLUTINATION TEST (K841319)Orion Diagnostica, Inc.1984-09-14
MACBETH COLOR EIAD 100/100PC (K842770)Macbeth1984-09-14
INORGANIC PHOSPHORUS TEST (K843177)Sclavo, Inc.1984-09-14
V AGAR SELECTIVE DEEPS (K843194)Remel Co.1984-09-14
SYSTEMATE PHOSPHORUS 67217 (K843330)Em Diagnostic Systems, Inc.1984-09-14
MICROBIOLOGICAL TRAY READER-MANUAL (K842947)American Micro Scan1984-09-14
GRAM STAIN SET W/STABILIZED IODINE (K843429)Accra Laboratories, Inc.1984-09-14
ID ZONE NORMAL LD ISOENZYME CONTROL (K843266)Beckman Instruments, Inc.1984-09-13
ELVI 675 DIGITRON (K843296)Logos Scientific, Inc.1984-09-13
JINOTTI OXYGEN/SUCTION CATHETER (K841425)Research Medical, Inc.1984-09-13
SYSTEMATE 2GT - 67207 (K843268)Em Diagnostic Systems, Inc.1984-09-13
SYSTEMATE URIC ACID, HEM 67220 (K843325)Em Diagnostic Systems, Inc.1984-09-13
AXIOM STABLE II TRIGLYCERIDES TEST (K842443)Axiom, Inc.1984-09-13
ID ZINE LD ISOENZYME CONTROL ABNORM (K843265)Beckman Instruments, Inc.1984-09-13
PATIENT GUIDED KNEE EXERCISER (K843493)Richards Medical Co., Inc.1984-09-12
ACETIC ACID 2% V/V (K842937)E K Ind., Inc.1984-09-12
PM 2000 DENTAL UNIT (K842357)Planmeca USA, Inc.1984-09-12
ACETIC ACID, 3% V/V (K842936)E K Ind., Inc.1984-09-12
DECOLORIZING FLUIC, ACID-ALCOHOL 3% (K842934)E K Ind., Inc.1984-09-12
BRITISH SPINAL FUSION SET (K842698)Downs Surgical , Ltd.1984-09-12
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