BEUDAMED
    11 results · 20ms · 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.
    Filters Regulation: Us FDA ×

    CADDY

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG,

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 19, 2025

    LEGION PS OXIN FEM SZ5 LT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 8, 2013

    AVAIRA (ENFILCON A)

    FDA Adverse Event
    Injury ·COOPERVISION MANUFACTURING, LIMITED·Product code LPL·March 29, 2011

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·May 9, 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

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012