BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    Stimuplex Onvision System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ANKLE ARTHRODESIS NAIL, LEFT 10X150MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010

    TQ HBA1C GEN3

    FDA 510(k)
    FDA Class 2 ·Hematology

    WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POUNCE VENOUS THROMBECTOMY SYSTEM

    FDA Adverse Event
    Injury ·SURMODICS INC·Product code QEW·May 16, 2024

    UNKNOWN

    FDA Adverse Event
    Injury ·DATASCOPE FAIRFIELD·Product code DSP·January 14, 2019

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 22, 2014

    HUDSON CONCHATHERM NEPTUNE HEATED HUMIDIFIER

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTT·July 22, 2011

    HIRES 90K IMPLANT

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·June 25, 2013

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    Quanta System Sterile Optical Laser Fiber, single use

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed for the creation of incisions in the cornea. The VisuMax Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia. This device is intended for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia >=-1.00 D to <=-8.00 D, with <=-0.50 D cylinder and MRSE <=-8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of <=0.50 D MRSE.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·December 25, 2019