BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    LTV2 Series Ventilators

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772344093·PROTECT.PRO ACTION BACK SUPPORT BLACK S

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112670·BARRON CORNEAL PUNCH 9.0MM

    36M - Black & Veach - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588011820·36M - Black & Veach - Metal

    Symmetry Olsen

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00841785102950·

    Apelo® / Apelo® MIS

    FDA UDI
    ATLAS SPINE, INC.·M68120108200000·Expansion Locking Collar Starter

    STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100

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

    ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 25, 2024

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·September 14, 2021

    ASCEND AC

    FDA Adverse Event
    Injury ·CALDERA MEDICAL, INC.·Product code FTL·October 20, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 1, 2011

    GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code MNB·July 2, 2013

    UNKNOWN FOTA SFTWR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OUG·July 1, 2025

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    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

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024