BEUDAMED
    20 results · 24ms · Sources: EU EUDAMED, US FDA

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    CREATINE KINASE (CK-NAC)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INSET II

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A DE C.V·Product code FPA·May 31, 2026

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0130120·Segmental Rod Reducer Driver

    CMC

    FDA UDI
    FGX INTERNATIONAL INC.·00887661664334·

    CMC

    FDA UDI
    FGX INTERNATIONAL INC.·00887661664310·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033523254·

    CMC

    FDA UDI
    FGX INTERNATIONAL INC.·00887661664327·

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132120·Trial, TLIF, 27L OB CRV 7Deg, 12mm

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134120·Trial, TLIF, 27L OB STR 7Deg, 12mm

    ALARMVIEW WIRELESS DATA NETWORK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PHOSPHORUS REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIDECO LILIPUT ECMO M PHISIO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·April 20, 2012

    SUNBEAM XPRESS HEAT XL HEATING PAD 12" X 24" WITH HEAT-METER

    FDA Adverse Event
    Injury ·SUNBEAM PRODUCTS INC.·Product code IRT·December 26, 2017

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code ILS·March 20, 2013

    TENDRIL STS

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011

    KYPHOPLASTY CEMENT

    FDA Adverse Event
    Injury ·Product code LOD·March 12, 2008

    Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912

    FDA Enforcement
    Class II ·Terminated·Clinician's Choice Dental Products Inc.·May 25, 2022

    OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912

    FDA Recall
    Terminated ·Clinician's Choice Dental Products Inc.·Product code ELW·March 18, 2022

    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