Atlas FDA

1988

4,299 FDA 510(k) clearances · Clearance year

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RecordFirmDate
BCYE AGAR (K880140)Hardy Media1988-03-30
INTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDES (K881107)Sigma Diagnostics, Inc.1988-03-30
ATS CRYPTOSPORIDIUM STAIN CONTROL SLIDES (K880962)Alpha-Tec Systems, Inc.1988-03-30
ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG (K873360)Endovations1988-03-30
CAMPY BROTH (K880107)Hardy Media1988-03-30
SABOURAUD DEXTROSE AGAR W/CHLORO (K880128)Hardy Media1988-03-30
CYSTINE TRYPTIC MEDIUM W/ MALTOSE (K880112)Hardy Media1988-03-30
CAMPLYOBACTER CULTURE MEDIA PRODUCTS P3873/T3597 (K880945)Lakewood Biochemical Co., Inc.1988-03-30
TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA (K880165)Ampcor, Inc.1988-03-30
ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION) (K881042)Alpha-Tec Systems, Inc.1988-03-30
CYSTINE TRYPTIC MEDIUM W/LACTOSE (K880113)Hardy Media1988-03-30
BCYE, SELECTIVE (W/MPA) (K880141)Hardy Media1988-03-30
MOELLOERS DECARBOXYLASE, ARGININE (K880118)Hardy Media1988-03-30
CYSTINE TRYPTIC MEDIUM W/DEXTROSE (K880110)Hardy Media1988-03-30
DERMATOPHYTE TEST MEDIUM (K880132)Hardy Media1988-03-30
NITRATE BROTH (K880135)Hardy Media1988-03-30
BRILLIANT GREEN BILE BROTH (K880129)Hardy Media1988-03-30
INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL (K881111)Sigma Diagnostics, Inc.1988-03-30
TSA W/LEC. & TWEEN. 80 (K880142)Hardy Media1988-03-30
CETRIMIDE SELECTIVE AGAR (K880136)Hardy Media1988-03-30
KALLESTAD QM300 CALIBRATOR C PACK (K880729)Kallestad Diag, A Div. of Erbamont, Inc.1988-03-30
ACETAMIDE AGAR SLANT (K880106)Hardy Media1988-03-30
LYME STAT TEST KIT (K875286)Whittaker Bioproducts, Inc.1988-03-30
RPR TEST FOR SYPHILIS IN SERUM OR PLASMA (K880477)Ampcor, Inc.1988-03-30
MOLTENO VALVE SETON (K875099)Staar Surgical Co.1988-03-30
ATS MEDIA (K880130)Hardy Media1988-03-30
CYSTINE TRYPTIC MEDIUM BASE (K880109)Hardy Media1988-03-30
CYSTINE TRYPTIC MEDIUM W/SUCROSE (K880111)Hardy Media1988-03-30
ONPG TEST REAGENT (K880139)Hardy Media1988-03-30
LC OXYGEN ANALYZER (K875183)Ametek/Thermox Instruments Division1988-03-29
WAKO(TM) IGA-HA DIRECT (K880803)Wako Chemicals USA, Inc.1988-03-29
SARA AGIE MONITOR (K874724)Ppg/Applied Resources, Inc.1988-03-29
PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM (K880072)Pharmacia Deltec, Inc.1988-03-29
CERULLO SUCTION REGULATOR (K880704)Aesculap Instruments Corp.1988-03-29
THUMPER MODEL P-1000 (K880597)Micro Tek Engineering1988-03-29
WASHING CATHETER (K875264)Endovations1988-03-29
RATEMINDER V INFUSION PUMP (K875174)Critikon Company, LLC1988-03-29
SOMATOM PLUS (K880965)Siemens Medical Solutions USA, Inc.1988-03-28
MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER (K875322)Schneider-Shilley (Usa)1988-03-28
JOHNSON & JOHNSON FLUFF SPONGE (K881222)Johnson & Johnson Professionals, Inc.1988-03-28
KINETIC FIBRINOGEN ASSAY (K881150)Bio/Data Corp.1988-03-28
MODIFIED SCHNEIDER-SHILEY WIRE TORQUER (K875323)Schneider-Shilley (Usa)1988-03-28
PICS-2000 (K880822)Philips Medical Systems, Inc.1988-03-28
GV 11 (TM), MODEL 9700 (K881082)Medical Devices, Inc.1988-03-28
SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX 350 (K880532)Fischer Imaging Corp.1988-03-28
COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV (K875367)Enzo Biochem, Inc.1988-03-28
TECNOL LASER SURGICAL MASK (K874894)Tecnol New Jersey Wound Care, Inc.1988-03-28
METATECH INTRACRANIAL PRESSURE MONITORING SYSTEM (K880154)Metatech Corp.1988-03-28
OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8 (K880044)Oxygen Enrichment Company, Ltd.1988-03-28
RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS (K880074)Romano Surgical Instrumentation, Inc.1988-03-25
VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY (K880547)Ventrex Laboratories, Inc.1988-03-25
PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL (K874136)Bio-Logic Systems Corp.1988-03-25
MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE (K871934)Lasermatic, Inc.1988-03-25
TENDON HARVESTER (K880414)Concept, Inc.1988-03-25
MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES (K875324)Schneider-Shilley (Usa)1988-03-25
CALCOFLUOR WHITE STAIN KIT (K880718)Remel Co.1988-03-25
NOVA LITE(TM) ANA (K880736)Inova Diagnostics, Inc.1988-03-25
DISPOSABLE ANGIOGRAPHIC, CONTROL SYRINGE (K873410)Blood Gas Supply Co.1988-03-25
NOVA GEL(TM) SS-A/SS-B (K880896)Inova Diagnostics, Inc.1988-03-25
MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT (K875327)Schneider-Shilley (Usa)1988-03-25
WAKO(TM) IGM-HA DIRECT (K880828)Wako Chemicals USA, Inc.1988-03-25
UTILITY CLAMP (K881084)Med-Dex Intl.1988-03-25
OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION) (K881060)Orthopedic Systems, Inc.1988-03-25
KALLESTAD QM2/QM300 CONTROL C PACK (K880730)Kallestad Diag, A Div. of Erbamont, Inc.1988-03-25
NOVA LITE(TM) DSDNA (K880742)Inova Diagnostics, Inc.1988-03-25
KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK (K880728)Kallestad Diag, A Div. of Erbamont, Inc.1988-03-25
SURGICAL SEALANT DISPENSER (SSD) (K881020)Micromedics, Inc.1988-03-25
MODEL 5050 SURGILASER FOR UROLOGY USE (K871932)Lasermatic, Inc.1988-03-25
ABBOTT IMX HCG (K880070)Abbott Laboratories1988-03-24
RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000 (K873824)Applied Laboratories, Inc.1988-03-24
LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE (K880452)Lumiscope Co., Inc.1988-03-24
OHMEDA MODULUS II PLUS ANESTHESIA SYSTEM (K875350)Ohmeda Medical1988-03-24
KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM (K875334)Kontron Instruments, Inc.1988-03-24
EBV-NA TEST (K880043)Gull Laboratories, Inc.1988-03-24
ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION (K880990)Alpha-Tec Systems, Inc.1988-03-24
TOTAL IRON BINDING CAPACITY (TIBC) (K880546)Boehringer Mannheim Corp.1988-03-24
WAKO(TM) AUTOKIT TOTAL PROTEIN (K880312)Wako Chemicals USA, Inc.1988-03-24
CORTISOL ENHANCED LUMINESCENCE ASSAY KIT (K880687)Amersham Corp.1988-03-24
UNIMETER CALIBRATION KIT (K880610)Boehringer Mannheim Corp.1988-03-24
CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) (K874875)Boots-Celltech Diagnostics, Inc.1988-03-24
MOBAY (BAYER) MAKROLON 2658 3291 (K873823)Applied Laboratories, Inc.1988-03-24
MOBAY (BAYER) MAKROLON 2658 1112 (K873820)Applied Laboratories, Inc.1988-03-24
INET MODEL BIOVISION (K873834)Inet Corp.1988-03-24
WAKO(TM) AUTOKIT ALBUMIN (K880313)Wako Chemicals USA, Inc.1988-03-24
MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS (K880170)Cooper Lasersonics, Inc.1988-03-24
THEOPHYLLINE TEST KIT REF. #A874799 (K880291)Photec Diagnostics, Inc.1988-03-24
WORD BARTHOLIN GLAND CATHETER CODE: 1005 (K880497)Hoosier Specialties, Inc.1988-03-24
GE LEXAN 144R 112 (K873825)Applied Laboratories, Inc.1988-03-24
EPIPACK (K880999)Clonetics Corp.1988-03-24
UTILITY WAX STRIPS, CINNAMON (K880606)Columbus Dental Mfg. Co.1988-03-24
PROTEIN BASE ISE CONTROL (K880710)Bionostics, Inc.1988-03-24
WAKO AUTOKIT URIC ACID (K880731)Wako Chemicals USA, Inc.1988-03-24
MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION (K880173)Cooper Lasersonics, Inc.1988-03-24
INORGANIC PHOSPHORUS REAGENT SET (K880676)Tech-Neal Scientific, Inc.1988-03-24
EMIT THYROXINE ASSAY (K880620)Syva Co.1988-03-24
GE NORYL 731-80089S (K873821)Applied Laboratories, Inc.1988-03-24
BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA (K881115)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-03-24
VITAACCESS (TM) CATHETER INTRODUCER SYSTEM (K872998)Vitaphore Corp.1988-03-24
WESBLOT PROCESSOR (K874887)American Bionetics, Inc.1988-03-24
STA-SET I.V. FLOW REGULATOR (K880006)Controlled Flow , Ltd.1988-03-24
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