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

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    KSEA ENDOTIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Dimension Hemoglobin A1c Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    READING CHARTS-CARDS (DISTANCE AND NEARPOINT)

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·February 22, 2013

    GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA

    FDA Adverse Event
    Malfunction ·OBTECH MEDICAL SARL_·Product code LTI·January 31, 2011

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·August 1, 2014

    The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room table immediately before, during and after surgical interventions as well as for examination and treatment. The fixture is used to adapt a range of different head and horseshoe head rests with a central square mount

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FQO·August 12, 2016

    Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment.

    FDA Recall
    Terminated ·Maquet Medical Systems USA·Product code FQO·October 5, 2016

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026