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

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    FDA 510(k)
    FDA Class 2 ·Pathology

    LCP

    FDA UDI
    Synthes GmbH·10886982166371·3.5MM LCP® POSTEROLATERAL DSTL HUMERUS PL-LAT S...

    ONE-STEP PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 29, 2025

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·March 25, 2009

    PEEK PUSHLOCK SP, 4.5 MM X 18.5 MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HWC·November 21, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    MINI TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·July 22, 2013

    UNKNOWN RICKHAM RESEVOIR

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·August 21, 2025

    FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026