BEUDAMED
    17 results · 27ms · Sources: EU EUDAMED, US FDA

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    BD GENEOHM STAPHSR ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BioQuick®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70710261·BioQuick-Brackets McLaugh/Benn/Trev. .018" 5 ca...

    Xsert Lumbar Expandable Interbody System

    FDA UDI
    Xtant Medical Holdings, Inc.·M697X0920710261·7mm-10mm x 10mm 26mm PLIF ASSY

    Bone Screws

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132134337·EXTENDED CLEANING BRUSH

    Xsert Lumbar Expandable Interbody System

    FDA UDI
    Xtant Medical Holdings, Inc.·M697X092071026STR1·7mm-10mm x 10mm 26mm PLIF ASSY (Sterile)

    3D-MSPECT

    FDA 510(k)
    FDA Class 2 ·Radiology

    FORTADERM WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    GPSIII 30ML PLATELET CONCENTRATION KIT WITH ACD-A

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KSS·August 22, 2018

    FULL FACE MASK

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code MNT·April 29, 2008

    DEPUY ASR XL FEM IMP SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·April 22, 2013

    NANOKNIFE SINGLE ELECTRODE PROBE, 15CM

    FDA Adverse Event
    Other ·ANGIODYNAMICS, INC.·Product code GEI·April 19, 2011

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·July 2, 2008

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·July 18, 2023

    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

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022