BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    PICCOLO BASIC METABOLIC PANEL

    FDA Adverse Event
    Malfunction ·ABAXIS, INC.·Product code CGX·October 22, 2020

    PICCOLO COMPREHENSIVE METABOLIC PANEL

    FDA Adverse Event
    Malfunction ·ABAXIS, INC.·Product code CGX·November 3, 2020

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867401167·2.4mm Snap-off FT Pin 40mm

    ASCENSION CANNULATED SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FDR SE Lite

    FDA 510(k)
    FDA Class 2 ·Radiology

    EARIGATOR

    FDA Adverse Event
    Malfunction ·SURYA TECHNOLOGIES INTERNATIONAL·Product code JYH·January 4, 2001

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 7, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·August 8, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

    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

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026