Atlas FDA

1992

3,665 FDA 510(k) clearances · Clearance year

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RecordFirmDate
AXIOM TOTAL KNEE SYSTEM AND PLUS TOTAL KNEE SYSTEM (K922734)Orthomet, Inc.1992-09-10
MAMMOSCAN (K923061)Fischer Imaging Corp.1992-09-10
CYBERNETIC OPTION (CYBER I) (K923986)Qualitone1992-09-10
CARDIAC TRIAD NEW DETECTOR OPTION (K923151)Trionix Research Laboratory, Inc.1992-09-10
IN-THE-EAR HEARING AID (K923918)Benway-Haworth-Lawlor Hearing Aids, Inc.1992-09-10
BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET (K920090)Helix Medical, Inc.1992-09-10
MRX-865 (K921130)Mrx-Ray Tube Corp.1992-09-10
MODEL 6213 REMOTE ALARM (K914424)Aequitron Medical, Inc.1992-09-10
MYOTRAC/S, MYODAC/S (K915859)Thought Technology , Ltd.1992-09-09
ULTRADENT PRODUCT TOOTH SURFACE DRYING AGENT (K921602)Ultradent Products, Inc.1992-09-09
MYOTRAC2 (K915858)Thought Technology , Ltd.1992-09-09
SYSTEMATE CALCIUM TEST TECHNICON RA 1000 (K922953)Em Diagnostic Systems, Inc.1992-09-09
SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO (K922857)Em Diagnostic Systems, Inc.1992-09-09
CORDIS SHUTTLE CATHETER W/ SIDEHOLES (K921311)Cordis Corp.1992-09-09
TURN EZ BED DEVICE (K922473)Med-Ez, Inc.1992-09-09
TOTAL BILIRUBIN CATALOG NO. 65407 (K923083)Em Diagnostic Systems, Inc.1992-09-09
ULTRADENT PRODUCT PIT & FISSURE SEALANT PROD LINE (K921598)Ultradent Products, Inc.1992-09-09
SYSTEMATE CREATININE TEST (K923203)Em Diagnostic Systems, Inc.1992-09-09
DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD (K922701)E.I. Dupont DE Nemours & Co., Inc.1992-09-09
MILES URINE UREA NITROGEN METHOD (K923035)Heraeus Kulzer, Inc.1992-09-09
SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000 (K923267)Em Diagnostic Systems, Inc.1992-09-09
DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR (K922698)E.I. Dupont DE Nemours & Co., Inc.1992-09-09
LUEKOFLEX SURGICAL TAPE (K923404)Beiersdorf, Inc.1992-09-09
URINE CHLORIDE (K923036)Heraeus Kulzer, Inc.1992-09-09
AMYLASE TEST (K923677)Em Diagnostic Systems, Inc.1992-09-09
SURGISTAR BLADES (K923689)Surgistar, Inc.1992-09-09
CLEANIC (K923020)Hawe Neos Dental1992-09-09
KING DIAGNOSTICS CHOLESTEROL REAGENT (K923128)King Diagnostics, Inc.1992-09-09
SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000 (K922856)Em Diagnostic Systems, Inc.1992-09-09
VENEER CEMENT (K923328)Dentsply Intl.1992-09-09
COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE (K921407)Ultradent Products, Inc.1992-09-09
ENAMEL AND PORCELAIN ETCH PRODUCT LINE (K921409)Ultradent Products, Inc.1992-09-09
MADAVAC 190 (K921611)Mada Medical Products, Inc.1992-09-09
ENDOPATH TISSUE RETAINING COMPONENT (K923679)Ethicon Endo-Surgery, Inc.1992-09-09
HCG PREGNANCY ONE STEP TEST STRIP (K923123)Tcpi, Inc.1992-09-09
KING DIAGNOSTICS GAMMA GT REAGENT (K923091)King Diagnostics, Inc.1992-09-09
NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC (K923186)Roho, Inc.1992-09-09
PATIENT EXAMINATION GLOVES (MAYCARE) (K915329)Malaysian Healthcare Sdn. Bhd1992-09-09
DURACON ALL PLASTIC TIBIAL COMPONENT (K922048)Howmedica Corp.1992-09-08
OMEGA PLUS COMPRESS HIP SCREW SYSTEM, MODIFICATION (K922295)Howmedica Corp.1992-09-08
KINEMAX PLUS ALL PLASTIC TIBIAL COMPONENT (K921640)Howmedica Corp.1992-09-08
MODEL ELI 200 ELECTROCARDIOGRAPH (K920626)Mortara Instrument, Inc.1992-09-04
DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST (K922364)Toshiba America Medical Systems, In.C1992-09-04
IRRIGATION TUBING SET (K921415)Psi Medical Products, Inc.1992-09-04
4240 DYNAMIC BP/HEART RATE MONITOR (K914260)Suntech Medical Instruments, Inc.1992-09-04
OXYGEN SWIVEL ADAPTER (PLASTIC) (K924225)Linjorel Products, Inc.1992-09-04
MAGNETIZATION TRANSFER CONTRAST (K922677)Resonex, Inc.1992-09-04
TRI-MED GASTRIC LAVAGE SYSTEM (K920619)Tri-Med Specialties, Inc.1992-09-04
ACUSON S228 TRANSDUCER FOR TRANSCRANIAL COLOR DOPP (K902515)Acuson Corp.1992-09-04
LABORIE URODYNAMICS PROCESSOR (K920777)R. Laborie Surgical , Ltd.1992-09-04
NEW FREEDOM ULTRA THIN PADS (K920830)Kimberly-Clark Corp.1992-09-04
SUPER GLOVES(R) HYPOALLERGENIC (K922495)Taiping Super Holdings Sdn Bhd1992-09-04
OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE (K920439)Omega Universal Technologies, Ltd.1992-09-04
MODEL ELI 100 ELECTROCARDIOGRAPH (K920627)Mortara Instrument, Inc.1992-09-04
TRI-MED QUICK-STEP GASTRIC LAVAGE KIT (K920527)Tri-Med Specialties, Inc.1992-09-04
SINGH SPEECH SYSTEM (SERIES 'SSS') (K912486)Exmoor Plastics , Ltd.1992-09-04
GUIDEWIRE (K921200)Lake Region Mfg., Inc.1992-09-04
STARKEY LABORATORIES OTOSCOPE (K922752)Starkey Laboratories, Inc.1992-09-04
VITAL INFUSION PUMP (K914122)Vital Resources Corp.1992-09-03
AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR (K915737)Electromedics, Inc.1992-09-03
DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS (K920743)Nihon Kohden America, Inc.1992-09-03
MONOPOLAR ELECTRODE (K915296)Lifeguard Medical Products, Inc.1992-09-03
AMK FIXED STEM CEMENTED TIBIAL TRAY (K922620)Depuy, Inc.1992-09-03
MEDI-STIM (K921491)Mid-Canada Medical1992-09-03
TL100W/12 (K922963)Philips Lighting Co.1992-09-02
WOODBINE XT350, XENON ARC LIGHT SOURCE (K922820)Woodbine Ptical Corp.1992-09-02
LOW PROFILE TRACHEOSTOMY TUBE (K922749)Concord/Portex1992-09-02
SPECTACLE FRAMES (K922258)British Optical Import Co.1992-09-02
URO-TOTE LEG BAG (K921024)Neotech Products, Inc.1992-09-02
AMERLITE PROLACTIN-30 ASSAY (K922170)Eastman Kodak Company1992-09-02
SOLUTION ADMINISTRATION SET (K921391)Douglas Medical Products Corp.1992-09-02
COTUBE PTH IRMA (K921949)Bio-Rad1992-09-02
BARTELS TOXOPLASMA IGG EIA (K922585)Baxter Diagnostics, Inc.1992-09-02
BARTELS EPSTEIN-BARR VIRUS IGM EIA (K922331)Baxter Diagnostics, Inc.1992-09-02
JANSEN-ANDERSON INSEMINATION SET (K914150)Cook Ob/Gyn1992-09-02
LABOTECH AUTOMATED MICROTITER ANALYZER (K922081)Innovative Medical Systems, Inc.1992-09-02
MONI-TROL-L AND MONI-TROL-XL (K920291)Medical Analysis Systems, Inc.1992-09-02
HOT SACK (K921395)C.F. Electronics, Inc.1992-09-02
BARTELS LYME DISEASE IGM EIA (K922578)Baxter Diagnostics, Inc.1992-09-02
BARTELS EPSTEIN-BARR VIRUS IGG EIA (K922332)Baxter Diagnostics, Inc.1992-09-02
DAVOL LAPAROSCOPIC LOOP AND RETRIEVAL DEVICES (K922526)Davol, Inc.1992-09-02
SALIVA-STIM (K914892)Orion Diagnostica, Inc.1992-09-02
TOTAL T3 CHEMILUMINESCENCE ASSAY (K923015)Nichols Institute Diagnostics1992-09-02
BARTELS TOXOPLASMA IGM EIA (K922579)Baxter Diagnostics, Inc.1992-09-02
BARTELS RUBEOLA IGM EIA (K922335)Baxter Diagnostics, Inc.1992-09-02
TUBING SET W/ IRRIGATION & ASPIRATION VALVING (K922246)Everest Medical Corp.1992-09-02
MODEL GT1ST CRYOSURGICAL INSTRUMENT (K922878)Gyne-Tech Instrument Corp.1992-09-02
THE NISSEL ARTIFICIAL EYE (K923167)Nissel , Ltd.1992-09-02
SUCTION IRRIGATION CAUTERY PROBE (K922002)Megadyne Medical Products, Inc.1992-09-02
VISOR SUNGLASSES/LENS/NOVELTY VISOR (K915266)Janlin Ent.1992-09-02
SOLAZ (K921685)Solarchromic, Inc.1992-09-02
ILLUMINATOR IV MINOR SURGERY LIGHT (K922279)Medical Illumination, Inc.1992-09-02
BARTELS RUBEOLA IGG EIA (K922330)Baxter Diagnostics, Inc.1992-09-02
KTP/532 & KTP/YAG (K913990)Laserscope1992-09-02
MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA (K922489)Porex Technologies Corp.1992-09-02
PHARMETRIX MEDIPUMP MODEL 524 (K915407)Pharmetrix, Inc.1992-09-02
LEOCOR CORFLO PUMP -- MODIFICATION (K924110)Leocor, Inc.1992-09-01
LITE FILL II P (K920893)Shofu Dental Corp.1992-09-01
CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER (K920846)Trinity Laboratories, Inc.1992-09-01
MEADOX SURGIMED BIOPSY GUN III (K922879)Meadox Medicals, Div. Boston Scientific Corp.1992-09-01
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Track 1992 automatically

Every clearance here is in the API, with alerts when new ones post.