BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    SAFEWEIGH MAGIC SCALE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556709679·GC Initial™ IQ/Effect Ingot B2-M, 4 pcs. X 5g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228725241·GC Initial™ IQ/Effect Ingot B2-M, 4 pcs. X 5g

    SURGICAL HAMMERS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Zimmer Persona Personalized Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·May 29, 2024

    WALKMED® 150 ML RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·WALKMED TECHNOLOGIES, LLC·Product code FRN·September 5, 2025

    VANGUARD ROCC POR FEM S60 L

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·February 3, 2026

    ROTICULATOR ENDO GRASP 5MM W/SPIN LOCK

    FDA Adverse Event
    Malfunction ·USSC PUERTO RICO·Product code GET·October 8, 2010

    GREENLIGHT HPS BPH FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·December 12, 2012

    GEMSTAR PAIN MGE ENG

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 18, 2014

    VANGUARD MONO FINNED STM TIB 71X8

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·August 9, 2023

    VANGUARD ROCC POR FEM S60 L

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code JWH·February 20, 2025

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

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