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

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    REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Laminoplasty

    FDA UDI
    Seaspine Orthopedics Corporation·10889981062170·Lamina Sizing Trial, 6mm

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123199·K-WIRE - SINGLE TROCAR THREADED 2.0mm DIA x 150mm

    "2.4MM" SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036056452·

    SalivaMAX

    FDA 510(k)
    FDA Unclassified ·Unknown

    UNI-THREAD SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SMART PERFUSION PACK: APEX MBR FMC/MID WEST REG LEXINGTON, KY

    FDA Adverse Event
    Injury ·Product code DTZ·September 11, 2007

    CONCERTO II CRT-D

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·February 9, 2013

    MAQUET, MOBILE O.R. TABLE, ALPHASTAR

    FDA Adverse Event
    Malfunction ·MAQUET GMBH·Product code FQO·March 5, 2014

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 7, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N030; c) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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