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

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    BENZ-G 4X HIOXIFILCON D

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    GOLD CORE POST SOLDER

    FDA 510(k)
    FDA Class 2 ·Dental

    RENAL GUIDING SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EEA 28MM SINGLE-USE STAPLER

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·June 1, 2015

    EEA31

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·August 31, 2015

    PREMIUM PLUS CEEA* 28 INSTR. W/TILT-TOP*

    FDA Adverse Event
    Injury ·COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN·Product code GDW·November 4, 2015

    IMUFLEX DISPOSABLES

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION/TERUMO BCT·Product code KSR·April 17, 2013

    IMMULITE 2500 STAT TROPONIN I

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·June 18, 2008

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·April 19, 2011

    DST SERIES ORVIL AUTOMATIC 25MM DEVICE

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·April 25, 2016

    CALCIUM

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES (IRVING IA/CC)·Product code CJY·September 1, 2020

    EEA 31MM SINGLE-USE STAPLER

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GAG·December 11, 2015

    SMALL POSTERIOR AUGMENT GLENOID PLATE, LEFT

    FDA Adverse Event
    Malfunction ·EXACTECH, INC.·Product code PHX·September 12, 2022

    Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, Lot ME07, 510 (K) K012854 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015