BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    OP-SITE SKIN CLOSURE SUTURE ADHESIVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5828018840·ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    ACUMED

    FDA UDI
    Acumed LLC·10806378052101·Coupling LQR to QR

    DIRECT CROWN

    FDA 510(k)
    FDA Class 2 ·Dental

    MAJOR.BASE 20

    FDA 510(k)
    FDA Class 2 ·Dental

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 11, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·October 23, 2012

    NUTRILINE PICC

    FDA Adverse Event
    Malfunction ·VYGON GMBH·Product code LJS·May 26, 2015

    REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTD·May 21, 2019

    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

    FDA Enforcement
    Class I ·Ongoing·Zyno Medical LLC·June 18, 2025

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024