BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    Modified ONFLEX Mesh

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383553391·Gutta Percha Points is used to root canal filin...

    OSSATURA DENTAL

    FDA 510(k)
    FDA Class 2 ·Dental

    CKMB UDR ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 24, 2013

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 26, 2014

    ENDOPATH STEALTH CIR STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code KOG·June 28, 2011

    BD INTIMA-II Y 22GAX1.00IN SS PRN SLM NPVC

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·June 27, 2025

    Cobe Optimin Hollow Fiber Sealed System, Sterile, (Custom Heart / Lung Pack), Catalog Numbers: 067350004, 067734001, 067736002. COBE Cardiovascular, Inc..

    FDA Recall
    Terminated ·Cobe Cardiovascular, Inc·Product code DTZ·June 26, 2006

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025