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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Dome Electrode

    FDA 510(k)
    FDA Class 2 ·Neurology

    6190416

    FDA Adverse Event
    Injury ·December 13, 2016

    ABL835 FLEX ANALYZER WITH PLEURAL PH

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INSULATION TESTER

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

    SYRINGE,FEEDING,FLT TP W/RNG,IV BAG

    FDA Adverse Event
    Malfunction ·MEDLINE INDUSTRIES, LP·Product code KYZ·March 14, 2024

    INTERTAN

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code HWC·October 21, 2014

    4.5MM CORTEX SCREW, SELF-TAPPING

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·July 28, 2011

    LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.), INFANT

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·June 19, 2013

    BD NEEDLE 22GA 1-1/4IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·July 29, 2020

    NEEDLE 22GA 1-1/4IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·August 7, 2020

    KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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