BEUDAMED
    20 results · 21ms · Sources: EU EUDAMED, US FDA

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    DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00600901·

    CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 90mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665020830·

    Medallion®

    FDA UDI
    Merit Medical Systems, Inc.·00884450021750·

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0600000·Tray Lid, Universal, Blank

    Canaveral®

    FDA UDI
    FLOSPINE LLC·B183120600900·6.0mm Curved Rod, Ti Alloy 90mm

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE, INC.·Product code JPA·December 8, 2006

    XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)

    FDA 510(k)
    FDA Class 2 ·Neurology

    GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE, INC.·Product code JPA·June 6, 2006

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE, INC.·Product code JPA·December 15, 2006

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 12, 2025

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE, INC.·Product code JPA·October 6, 2006

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 20, 2013

    NOVASURE

    FDA Adverse Event
    Malfunction ·HOLOGIC, INC.·Product code MNB·April 6, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 11, 2008

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE, INC.·Product code JPA·August 24, 2006

    PK DISSECTING FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 23, 2013

    UNKNOWN

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·June 8, 2018

    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024