BEUDAMED
    15 results · 32ms · Sources: EU EUDAMED, US FDA

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    KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    HairCheck-DT (Amphetamines)

    FDA UDI
    Quest Diagnostics·00868586000230·HairCheck-DT (Amphetamines) is an ELISA test ki...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704282900·HIBBS RETRACTOR 9 1/2" 100 MILLIMETER

    MILLENNIUM

    FDA UDI
    Avalign Technologies, Inc.·00190776314705·Hibbs Retractor

    MODIFICATION TO CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11

    FDA 510(k)
    FDA Class 1 ·Dental

    ADAPTA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·April 10, 2013

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code MTA·April 5, 2011

    UNKNOWN DEPUY TIBIAL INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSH·May 21, 2008

    NANOTITE TM CERTAIN PREVAIL IMPLANT 4/5/4 X 15MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·December 4, 2023

    MEDTRONIC NAVIGATION

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC·Product code HAW·March 9, 2022

    ARROW CVC SET: 3-LUMEN 12 FR X 25 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code DQY·November 2, 2022

    O-ARM IMAGING SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OXO·March 9, 2022

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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