BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    LAB-SITE SAFETY NEEDLE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    ABSELE* ABSORBABLE BONE SEALANT

    FDA 510(k)

    VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    REPAIR CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·November 12, 2010

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    FDA Adverse Event
    Malfunction ·TENEX HEALTH·Product code LFL·February 24, 2014

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 29, 2012

    Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    FDA Enforcement
    Class I ·Terminated·Animas Corporation·April 10, 2013

    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

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025