BEUDAMED
    21 results · 33ms · 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.

    ADVIA Centaur Anti-Thyroid Peroxidase II

    FDA 510(k)
    FDA Class 2 ·Immunology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776153663·5MM 32CM JACKSON RING ROTATION GRASPER STAINLES...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776183196·Lambotte Osteotome str

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120755·Guidewire 2.5x250mm Drill Tip

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120762·Guidewire 2.5x250mm Sgl Trocar

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690122777·Modular Stem 25mm x 100mm

    DUAL CHAMBER EMPTY CONTAINER

    FDA Adverse Event
    Malfunction ·SECURE MEDICAL PRODUCTS·Product code KPE·May 6, 1996

    AQUIFY MULTIPURPOSE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SternSnap Angled Attachment

    FDA 510(k)
    FDA Class 2 ·Dental

    EASY PUMP

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL INC.·Product code MEB·February 23, 2023

    QUADRA R FEMORAL STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·March 30, 2026

    CD3200SL 110

    FDA Adverse Event
    Other ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·April 26, 2007

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 14, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013

    COMPR RVS GLENO 2-PRNG INS/IMP

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code PHX·October 16, 2023

    EASYPUMP® II

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code MEB·June 17, 2016

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

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

    The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·July 20, 2016