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

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    Hemoclip

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

    BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE

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

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 23, 2024

    CONTOUR® PLUS BLUE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 12, 2026

    ESSURE

    FDA Adverse Event
    Malfunction ·CONCEPTUS, INC.·Product code HHS·October 10, 2008

    UNKNOWN DEPUY STEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·August 10, 2011

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 8, 2013

    CONTOUR® CARE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 3, 2025

    CONTOUR® CARE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 23, 2026

    CONTOUR® NEXT

    FDA Adverse Event
    Injury ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 8, 2025

    CONTOUR® PLUS ELITE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 8, 2025

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·January 25, 2018

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025