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

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    BILI-THERAPY SPOT TYPE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MLX

    FDA UDI
    Nuvasive, Inc.·00887517268181·MLX, 10x38x28mm 8°

    MLX

    FDA UDI
    Nuvasive, Inc.·00887517265364·MLX, 10x38x28mm 4°

    MLX

    FDA UDI
    Nuvasive, Inc.·00887517263858·MLX, 10x38x28mm 12°

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·November 10, 2022

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857520486·Split Tube Retractor, Size Ø16x100 mm

    VASO PRESS DVT FOOT GARMENT #VP 520

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GLOVCO EBONY

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGES 1ML

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·June 22, 2023

    AGX

    FDA UDI
    Widex A/S·05706069748314·Audigy AGXWU-FM (Winter silver S-330 ) RC coil

    AGX

    FDA UDI
    Widex A/S·05706069749168·Audigy AGXWU-FP (Winter silver S-330 ) Telecoil...

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 3, 2024

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·February 3, 2022

    PROSOUND F75 ULTRASOUND SCANNER

    FDA Adverse Event
    Malfunction ·HITACHI ALOKA MEDICAL, LTD·Product code GXX·July 16, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 19, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 26, 2011

    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 All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021