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

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    SONIC SCALER

    FDA 510(k)
    FDA Class 2 ·Dental

    ULTRASORB SUTURE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 8, 2020

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·June 30, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 8, 2013

    GOBED+

    FDA Adverse Event
    Other ·STRYKER MEDICAL QUEBEC, LP·Product code FNL·November 12, 2010

    DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    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