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

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    CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)

    FDA 510(k)
    FDA Class 2 ·Dental

    NA

    FDA UDI
    Synthes GmbH·10886982157690·3.5MM MEDIAL DISTAL TIBIA PLATE 6 HOLES/95MM-LEFT

    Drive Rail System

    FDA UDI
    ORTHOPEDIATRICS CORP.·00817867020658·SCREW, SHORT, CLAMP TO CARRIAGE

    KCI NPWT GAUZE DRESSING

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODIFICATION TO GELBFISH VASCULAR DILATORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 25, 2011

    PROSTHESIS, KNEE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·July 12, 2013

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026