BEUDAMED
    14 results · 25ms · Sources: EU EUDAMED, US FDA

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    H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Versacryl

    FDA UDI
    Keystone Industries·H66810140131·Acrylic SC Pre-Mixed Liquid 60 ml

    ANODYNE Plate System

    FDA UDI
    CORELINK LLC·M7252014013·ANODYNE CERVICAL SCREW - VARIABLE SELF DRILLIN...

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193101903·EVOS Straight HA PEEK 13mm x 9mm x 22mm Flat, 5...

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QJR·June 30, 2021

    ELLUME COVID-19 HOME TEST

    FDA Adverse Event
    Malfunction ·ELLUME LIMITED·Product code QKP·December 20, 2021

    IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

    IDENTITY XL DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·March 10, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 13, 2008

    WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·April 22, 2015

    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·November 24, 2021

    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