BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    VPAP TX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123274·K-WIRE - DOUBLE TROCAR 1.8mm DIA x 150mm

    MASTER & FRANK SURGICAL GOWNS (STERILE)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VASCULAR ASSIST

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    56MM AND R3 ACETABULAR SHELL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018

    HUDSON/MODIFIED TRINKLE REAMER

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·May 3, 2013

    SCS LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MED - NEUROMODULATION·Product code GZB·September 3, 2014

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code MUZ·April 27, 2011

    COCR FEMORAL BALL HEAD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·October 31, 2025

    VERSAFITCUP DM PE LINER

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·June 3, 2016

    ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall. The ABL90 FLEX is a portable, automated analyzer that measures pH, blood Gases, electrolytes, glucose, lactate and oximetry in whole blood. The ABL90 FLEX is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CEM·January 12, 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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012