BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TRIO LX SMALL CONNECTOR

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code MNI·March 23, 2011

    VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PERSONAL GLUCOSE CONTROL CHARTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 17, 2025

    SCREW-IN

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·April 17, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 18, 2008

    FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS·Product code LXB·April 19, 2011

    Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24

    FDA Enforcement
    Class II ·Ongoing·ICU Medical Inc.·September 10, 2025

    Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" W/L.

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·June 8, 2016

    Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom kits used for general surgery in hospital operating room

    FDA Recall
    Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·April 22, 2015

    Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" W/L.

    FDA Recall
    Terminated ·Windstone Medical Packaging, Inc.·Product code LRS·March 21, 2016

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015