BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    Dental Handpiece

    FDA 510(k)
    FDA Class 1 ·Dental

    BLUE MOUNTAIN CERVICAL PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HRV ACQUIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 4, 2024

    MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH

    FDA Adverse Event
    Malfunction ·SIRONA DENTAL SYSTEMS GMBH·Product code EFB·April 20, 2023

    FLEXIBLE SILICONE DRILL DRIVER

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HTW·October 28, 2025

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 22, 2014

    CARESCAPE MONITOR B850

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MHX·July 20, 2011

    SM104 MSERIES W5TH WHLOBS3/07

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 27, 2013

    INSTINCT ENDOSCOPIC HEMOCLIP

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code PKL·July 19, 2021

    INSTINCT ENDOSCOPIC HEMOCLIP

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC·Product code PKL·September 12, 2022

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014