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

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    PHOENIX HEMODIALYSIS DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857520523·Split Tube Retractor, Size Ø18x40 mm

    SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 9, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

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

    NI

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·May 18, 2011

    GALAXY G3 XSFT 3.5MM X 7.5CM

    FDA Adverse Event
    Injury ·CERENOVUS, INC.·Product code KRD·July 7, 2023

    GALAXY G3 4MM X 7CM

    FDA Adverse Event
    Injury ·CERENOVUS, INC.·Product code KRD·July 7, 2023

    GALAXY G3 XSFT 2MM X 2CM

    FDA Adverse Event
    Injury ·CERENOVUS, INC.·Product code KRD·July 7, 2023

    GALAXY G3 XSFT 3.5MM X 7.5CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·June 15, 2022

    GALAXY G3 XSFT 2MM X 2CM

    FDA Adverse Event
    Injury ·CERENOVUS, INC.·Product code KRD·July 7, 2023

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024

    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

    Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015