BEUDAMED
    15 results · 28ms · Sources: EU EUDAMED, US FDA

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    AMBU MARK IV RESUSCITATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00531401·

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690197102·Revision Knee Spiral Reamer- Hudson Short Flute...

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981174101·L Con, Side-Loading, L, 16mm, 140mm

    RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·February 15, 2022

    I-STAT CARTRIDGE

    FDA Adverse Event
    Injury ·ABBOTT POINT OF CARE·Product code CHL·August 8, 2014

    G7 LONGEVITY 10DEG LNR 32MM C

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·October 22, 2021

    ATLANTIS? SR PRO²

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code DQO·April 11, 2013

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 13, 2011

    ETS FLEX ARTICNG LNR CUTR 45MM

    FDA Adverse Event
    Injury ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GDW·May 20, 2008

    Thermalon Neck Wrap, Item Number 24322

    FDA Enforcement
    Class II ·Ongoing·Bruder Healthcare Company, LLC·April 3, 2024

    i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code JGS·February 15, 2011

    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