BEUDAMED
    23 results · 20ms · Sources: EU EUDAMED, US FDA

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    Admiral ACP System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    10M - General Purpose

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588020143·General Purpose - 10 Metal

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112533·BARRON VACUUM TREPHINE 8.5MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112472·BARRON VACUUM TREPHINE 7.0MM

    COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BD FACS SAMPLE PREP ASSISTANT III (SPA III)

    FDA 510(k)
    FDA Class 2 ·Hematology

    Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024119048·

    Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024119062·

    Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024119055·

    GORE-TEX STRETCH VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DSY·August 19, 2021

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·January 12, 2021

    MALLINCKRODT THREE WAY STOPCOCK

    FDA Adverse Event
    Malfunction ·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code FMG·October 15, 2008

    EON MINI

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 27, 2013

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·August 5, 2011

    Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic

    FDA Enforcement
    Class II ·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013

    Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic

    FDA Recall
    Terminated ·Surgical Instrument Service And Savings, Inc.·Product code HRH·May 3, 2013

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·July 5, 2022

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT

    FDA Adverse Event
    Injury ·AMO MANUFACTURING NETHERLANDS·Product code KYF·June 10, 2021

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025