BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996

    FDA 510(k)
    FDA Class 2 ·Immunology

    Cortera

    FDA UDI
    Xtant Medical Holdings, Inc.·00840311210466·Tap, Cann, Jacobs, 4.5

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981175672·Z-Rod, Dia. 5.5mm, Co-Cr, 450mm

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0604500·Tray, Base, 4.5"

    RIVA Pedicle Screw System

    FDA UDI
    XENIX MEDICAL LLC·00840493419886·Z-ROD, 6.0mm x 450mm

    RIVA Pedicle Screw System

    FDA UDI
    XENIX MEDICAL LLC·00840493419619·Z-ROD, 5.5mm x 450mm

    MODIFICATION TO SYNTHES USS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIVER TAMPONADE BALLOON

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    C & B FORMULA

    FDA UDI
    AMERICAN TOOTH INDUSTRIES·D772ATI400404500·C & B FORMULA 4 OZ SHADE 50

    STELLARIS 25G VIT CUTTER 6/BX

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code HQC·April 3, 2013

    FREESTYLE FLASH

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code LFR·May 8, 2008

    XPERT SELF-EXPANDING STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code FGE·April 5, 2011

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024