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

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    EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0830090·Persuader, Rod Reduction, Kerrison Type

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776391263·Adjustable Vertebral Body Retractor, 30mm

    SeaSpine

    FDA UDI
    Avalign Technologies, Inc.·00190776149444·ADJUSTABLE VERTEBRAL BODY RETRACTOR, 30mm

    AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MODIFICATION TO: QWH-420 WRIST ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTISAN

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 21, 2024

    XXL ESOPHAGEAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNQ·February 27, 2019

    CYLOS VR

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code DXY·April 29, 2013

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 12, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·July 24, 2008

    BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·March 10, 2025

    Performer

    FDA UDI
    COOK INCORPORATED·00827002126336·Check-Flo Performer Introducer Set Micropunctur...

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015