BEUDAMED
    10 results · 17ms · 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.

    SEARLE VASCULAR LOOPS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    VENTED HIGH VOL. INLET, N/S

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - ROUND LAKE·Product code LHI·April 23, 2019

    MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A

    FDA 510(k)
    FDA Class 2 ·Radiology

    RE-TRACE URETERAL ACCESS SHEATH

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CONSERVE(R) TOTAL HEAD W/BFH

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code KWA·May 9, 2014

    RAYTEK

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH·Product code GDY·October 5, 2012

    SERVO VENTILATOR 300

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·August 11, 2010

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    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