BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

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    CLASSIC CEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040013403·Zirlux 16+ A3 98.5X14

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01106N0·Cervical Trial, 14 x 11, 6mm, 0 Degree, No Taper

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 30, 2025

    iASSIST

    FDA UDI
    Orthosoft Inc·00889024305489·

    4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190

    FDA 510(k)
    FDA Class 2 ·Hematology

    BEHRING COAGULATION TIMER ANALYZER (BCT)

    FDA 510(k)
    FDA Class 2 ·Hematology

    ENDOCARE, CRYOCARE, CRYOPROBE

    FDA Adverse Event
    Malfunction ·HEALTHTRONICS, INC.·Product code GEH·April 2, 2012

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2026

    UNKNOWN DEPUY METAL FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. ? REG. # 8010379·Product code KWA·March 19, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·March 8, 2011

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL AB·Product code DTB·March 10, 2008

    Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 11, 2024

    GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.Sold under the following product names: BEIJING CT OPTIMA 540, BEIJING OPTIMA, BEIJING OPTIMA 540, BEIJING OPTIMA 540 ASIR, CT BEIJING OPTIMA 540, CT BEIJING OPTIMA 540 ASIR, CT GOLDSEAL OPTIMA 540, CT OPTIMA 540, CT OPTIMA 540 ASIR, CT OPTIMA CT540 TANG BEIJING, DISCOVERY 670 3/8 MEA PRO, HINO OPTIMA 540, HINO OPTIMA 540 ASIR, HINO OPTIMA 540 ASIR, OPTIMA 540, OPTIMA 540 ASIR, OPTIMA 540 MOBILE BEIJING, OPTIMA CT540, OPTIMA CT540 32 SLICES, OPTIMA CT540 ASIR, OPTIMA CT540 BJG SKD RUSSIA, Optima CT540 Gantry Top Asm with Rating Plate,SGB tube and CJ cover, Optima CT540 Gantry Top Asm with Rating Plate,SGB tube and CJ cover for Hino, OPTIMA CT540 TANG, OPTIMA CT540 TANG BEIJING, OPTIMA CT540 TANG HINO

    FDA Enforcement
    Class II ·Terminated·GE Healthcare Japan Corporation·August 29, 2018

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021