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

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    OrthoNext Platform System

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295123415·CEMENTLESS DEL SYS CASE

    LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    STAT K IN VITRO DIAGNOSTIC TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TARGETING ARM PROX. LAT TIBIA LEFT

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·February 2, 2012

    GDC-10 ULTRASOFT COIL

    FDA Adverse Event
    Injury ·NEUROVASCULAR DIV, BOSTON SCIENTIFIC CORP·Product code HCG·November 19, 2008

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011

    GYNECARE TVT-AA ABDOMINAL

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 23, 2013

    METRIX AIR

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·September 18, 2018

    COMPRESS/FINN TRANSVERSE PIN SIZE 44MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·August 6, 2018

    COMPRESS CUSTOM ANCHOR PLUG 19MM SHORT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 6, 2018

    COMPRESS/FINN SPACER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·April 17, 2018

    UNKNOWN PEEK SUTURE ANCHOR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBI·November 3, 2023

    DEKA LIPOAI

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 4, 2025

    Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    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