BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

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    KENDRO HERACELL 240 INCUBATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Safco Surgical Length Bur

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310234653·Safco surgical length bur, #558 crosscut straig...

    nSpire Health

    FDA UDI
    NSPIRE HEALTH, INC.·10852417003696·KoKo Standard White Filter Kit with Nose Clip a...

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120234651·Carbide, round, rosehead, fast cutting, green ring

    MEDCOMP ASH SPLIT-CATH II

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

    ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·March 27, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 8, 2011

    MIDDLE SCREW EXTENDER SLEEVE

    FDA Adverse Event
    Malfunction ·ABBOTT SPINE, INC.·Product code LXH·April 2, 2008

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 2015

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021