BEUDAMED
    11 results · 18ms · 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.

    SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1

    FDA 510(k)
    FDA Class 2 ·Dental

    K082959

    FDA UDI
    Unimed Medical Supplies, Inc.·06945664812412·SpO2 interface cable/Philips-Masimo/2.2M/309+12...

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06936735463947·One-piece ECG Monitor Cable Philips

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970560·

    MODIFICATION TO ISOBAR SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GLO-SPEC I, II AND III

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TRUE RESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·March 21, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·February 24, 2011

    *

    FDA Adverse Event
    Malfunction ·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code JOH·March 26, 2008

    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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024