BEUDAMED
    13 results · 27ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776147280·Malis Type Biopolar Forcep, bayonet, insulated,...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776123840·Malis Type Biopolar Forcep,

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209138326·

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111292880·MCGIVNEY HEMORRHOID LIGTR SET

    21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A)

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 4, 2014

    DELTA CER HEAD 12/14 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LZO·October 23, 2012

    MAGIC 3 FEMALE INTERMITTENT CATHETER

    FDA Adverse Event
    Malfunction ·ROCHESTER MEDICAL CORP·Product code KOD·May 27, 2015

    Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18; and Instructions for Use, Part: M056989CDOC2

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics, Inc.·March 12, 2025

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

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

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013