BEUDAMED
    18 results · 22ms · 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 ×

    Alians Fragment Specific

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ABREU, MODEL 700

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COMFORT TOUCH INSUIN PEN NEEDLES

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA TECHNOLOGY CO., LTD.·Product code FMI·May 21, 2021

    MINIMAX STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 24, 2025

    MINIMAX RIGHT ANATOMICAL BROACH SIZE 2

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LXH·February 20, 2020

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 6, 2019

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 7, 2013

    ACCU-CHEK RAPID D LINK

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FPA·June 22, 2011

    INFUSOR LV10 SYSTEM

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code MEB·September 24, 2008

    MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 2

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2017

    LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMF

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·April 4, 2019

    CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 4, 2019

    CUP: VERSAFITCUP ACETABULAR SHELL Ø 48

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·December 27, 2019

    InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.

    FDA Recall
    Terminated ·Intervascular S.A.S. Zone Industrielle Athelia I La Ciotat Cedex France·Product code DSY·December 9, 2009

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 8, 2021

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·November 2, 2020

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024