Atlas FDA

1992

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

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RecordFirmDate
DALLA BONA BALL & SOCKEY ATTACH. SNAP TYPE PRECIS (K921764)Implant Support Systems, Inc.1992-11-03
LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100 (K921493)Welch Allyn, Inc.1992-11-03
PHONAK PICO-FORTE C-2 BTE HEARING INSTRUMENT (K924912)Phonak, Inc.1992-11-03
CARDIOVIT CS-100 (K914970)Schiller America, Inc.1992-11-03
STETHOSCOPE COVER (K923327)Anup Chakraborty Co.1992-11-03
DFS GENIUS BTE (K924185)Gn Danavox, Inc.1992-11-03
DIGITAL BLOOD PRESSURE MONITOR MODEL #UF-101 (K921627)Showa Engineering Co., Ltd.1992-11-03
KINAMED 32MM BIOCERAM-Z TOATAL HIP FEMORAL BALL (K920290)Kinamed, Inc.1992-11-03
S1500 XENON LIGHT SOURCE (K922837)Endomedix1992-11-03
MEDELEC 2110 AND 2114 EEG (K922548)Medelec Intl. Corp.1992-11-03
VITALERT 3000 MONITORING SYSTEM (K913995)Draeger Medical, Inc.1992-11-03
HARRIS MODEL 2000 (K921906)Harris Mfg. Co.1992-11-02
ACCUTEX SLE LATEX TEST (K924248)J.S. Medical Assoc.1992-11-02
321Q MINIMUM ENERGY TINNITUS SUPPRESSOR (K922572)Microbio-Medics, Inc.1992-11-02
IBT MODEL SVI (K921821)Biomagnetic Technologies, Inc.1992-11-02
CMS RECORD AND VERIFY (K921108)Computerized Medical Systems, Inc.1992-11-02
REP IMMUNOFIX (K923658)Helena Laboratories1992-11-02
SYVA EMIT II PROPOXYPHENE ASSAY (K923873)Syva Co.1992-11-02
TAD MODEL #9655 (K921898)Loric Technology1992-11-02
CEFPODOXIME 10 MCG, SENSI DISC (K924797)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-11-02
KALESTAD ANA MICROPLATE EIA (K924087)Bio-Rad Laboratories, Inc.1992-11-02
DGH-500 PACHYMETER (K920906)Dgh Technology, Inc.1992-11-02
SEHRIST VOLUME VENTILATOR, MODEL 2200B (K914607)Sechrist Industries, Inc.1992-11-02
STC DIAGNOSTICS AUTO-LYTE(TM) PCP EIA (K924462)Solarcare Technologies Corp,Inc.1992-11-02
MEDGRAPHIX INTL VR 1000 SERIES (K921381)Medgraphix Intl.1992-11-02
NIZYME TEST KIT (K923566)Remel Co.1992-11-02
ACCUTEX IM RBC TEST (K924037)J.S. Medical Assoc.1992-11-02
KING DIAGNOSTICS GLUCOSE (HK) REAGENT (K923129)King Diagnostics, Inc.1992-11-02
I-STAT(TM) LEVELS 1,2,3 CONTROLS (K921477)I-Stat Corp.1992-11-02
SUB-4 SMALL VESSEL BALLOON DILATATION CATHETER (K924047)Boston Scientific Corp1992-11-02
VSI 1000 (K912921)Vitaltrends Technology, Inc.1992-10-30
ELECTROTRACE, MODIFICATION (K924133)Jason Marketing Co.1992-10-30
CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR (K921936)Cordis Corp.1992-10-30
KINAMED 26MM BIOCERAN-Z TOTAL HIP FEMORAL BALL (K920219)Kinamed, Inc.1992-10-30
ATRAUM WOUND DRESSING--MODIFICATION (K922760)Axiom Medical, Inc.1992-10-30
GERMAN MINI DYNALOCK (K923432)Unitek Corp.1992-10-30
CONVEEN(R) LEG BAG(500 ML) (K924406)Coloplast A/S1992-10-30
NASOGRASTRIC TUBBE HOLDER (K922209)Innovative Medical Design Corp.1992-10-30
BARD BIOPSY FORCEPS (K922086)C.R. Bard, Inc.1992-10-30
BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP (K915580)Belmont Instrument Corp.1992-10-30
3D IMAGING (K923823)Resonex, Inc.1992-10-30
DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED (K922479)Intertech Resources, Inc.1992-10-30
OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR (K923616)Osteonics Corp.1992-10-30
VIBROTACTILE TESTER, MODEL NO. VTT-100 (K921560)Topical Testing, Inc.1992-10-30
FRAY BIO-PUNCH (K921822)Fray Products Corp.1992-10-28
CONVERTORS STERILIZATION WRAP (K921243)Baxter Healthcare Corp1992-10-28
LIPASE HYDROLYSIS/GLYCEROT KINASE ENZYME, TRIGLYC (K924694)Olympus Corp.1992-10-28
DEXTRON SURGICAL GLOVES (K921804)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-10-28
SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB. (K915848)Sensor Medics Corp.1992-10-28
EVACUATOR, GASTRO-UROLOGY (K921451)Northgate Technologies, Inc.1992-10-28
ASTRA T2, ASTRA T4, ASTRA T6 (K920601)Cardiac Pacemakers, Inc.1992-10-28
ENTRAC URETERAL BALLOON DILATION CATHETERS (K921839)American Medical Systems, Inc.1992-10-28
EVACUATOR, GASTRO-UROLOGY (K921088)Northgate Technologies, Inc.1992-10-28
BOSTON CLEANER II (K923437)Polymer Technology Corp.1992-10-28
ROYL-DERM WOUND HYDROGEL (K922815)Renaissance Medical, Inc.1992-10-28
AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP (K923539)American Dental Laser, Inc.1992-10-28
EUDERMIC POWDER-FREE SURGICAL GLOVES (K915807)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-10-28
ZEISS VISULAS ARGON LASER (K923341)Carl Zeiss, Inc.1992-10-28
ASI UROPLASTY LASER CYSTOSCOPE (K921990)Advanced Surgical Intervention, Inc.1992-10-28
PATIENT EXAMINATION GLOVES (K923592)Hindustan Latex , Ltd.1992-10-28
120 FR OPTILUME PROSTATE BALLOON DILATOR (K920551)American Medical Systems, Inc.1992-10-28
FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM (K921690)Vision-Sciences, Inc.1992-10-28
IPS CERAMIC ETCHING GEL (K923926)Ivoclar North America, Inc.1992-10-27
DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER (K920375)Telos Medical Corp.1992-10-27
PURITAN-BENNETT MODEL 7200AE VENTILATOR (K923809)Puritan Bennett Corp.1992-10-27
DMG100 AND 500 ISOMETRIC STRENGTH DYNAMOMETER (K923262)John Chatillon & Sons, Inc.1992-10-27
IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM (K921854)Impla-Med1992-10-27
CHALLENGE II - PASTE ADHESIVE (K923399)Ormco Corp.1992-10-27
TSRH L CONNECTOR -- MODIFICATION (K923339)Sofamor Danek Mfg., Inc.1992-10-27
REGALTECH MAXISCOPE (K921163)Regaltech Pty. , Ltd.1992-10-27
QUICKANCHOR (K924665)Mitek Surgical Products, Inc.1992-10-27
ACQSIM SIMULATOR/LOCALIZER (K923851)Philips Medical Systems (Cleveland), Inc.1992-10-27
SENSORMEDICS 4000 SERIES SLEEP SYSTEM (K915856)Sensor Medics Corp.1992-10-26
IL TEST APOLIPOPROTEIN A1 (K923087)Instrumentation Laboratory CO1992-10-26
TIMESH TITANIUM MINI-SOFTPLATE/SCREW (K923802)Ti-Mesh, Inc.1992-10-26
VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH (K921352)Vygon Corp.1992-10-26
REMEL LOMEFLOXACIN 10 MCG SUSCEPTIBILITY DISK (K924765)Remel Co.1992-10-26
LOPEZ VALVE WITH NG SUMP TUBE (K921104)Icu Medical, Inc.1992-10-26
VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER (K921374)Vygon Corp.1992-10-26
CORDIS STEERABLE GUIDEWIRE (K923134)Cordis Corp.1992-10-26
IL TEST AST, PN 35312 (K923641)Instrumentation Laboratory CO1992-10-26
STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED (K924074)Baxter Diagnostics, Inc.1992-10-26
KODAK AMERLITE MAB FT3 ASSAY (K922713)Eastman Kodak Company1992-10-26
SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM (K920111)Sensor Medics Corp.1992-10-26
COAG-CONTROL [N] KIT (K922174)American Bioproducts Co.1992-10-26
DIAMOND COATED DENTAL INSERTS (K923639)Dentsply Intl.1992-10-26
IL TEST APOLIPOROTEIN B (APO B) (K923080)Instrumentation Laboratory CO1992-10-26
CHOLESTEROL TEST (K923733)Em Diagnostic Systems, Inc.1992-10-26
IL TEST PT FIBRINOGEN HS (K923921)Instrumentation Laboratory CO1992-10-26
REMEL OFLOXACIN 5MCG SUSCEPTIBILITY DISK (K924766)Remel Co.1992-10-26
SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR (K922037)Micromedical Technologies, Inc.1992-10-26
VERT-X UNIVERSAL VERTICAL BUCKY STAND (K922443)Afp Imaging Corp.1992-10-26
BECKMAN VALPROIC ACID REAGENT (K922844)Beckman Instruments, Inc.1992-10-26
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (K923122)Biomerieux Vitek, Inc.1992-10-26
VENTILATOR CIRCUITS (K920885)Vital Signs, Inc.1992-10-23
RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE (K913893)Depuy, Inc.1992-10-23
TX-3 SD (K923934)Skylark Device Co., Ltd.1992-10-23
8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS (K921755)Davol, Inc.1992-10-23
INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR (K924451)Interventional Therapeutics Corp.1992-10-23
LUNDEEN SUBTALAR PEG IMPLANT (K922292)Sgarlato Laboratories, Inc.1992-10-23
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Every clearance here is in the API, with alerts when new ones post.