BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    CONVERTORS OPTI-SORB DRAPE MATERIAL

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

    Crown cutter

    FDA UDI
    DFS - DIAMON GmbH·04057176151155·ZIRCUT crown cutter HP, pu: 1 pc

    Varex Imaging

    FDA UDI
    Varex Imaging Nederland B.V.·08718755001587·The device is intended to be used in medical di...

    SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    8MP COLOR LCD MONITOR, RADIFORCE RX850

    FDA 510(k)
    FDA Class 2 ·Radiology

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 29, 2013

    SJM MECHANICAL HEART VALVE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL PUERTO RICO, INC. (CS)·Product code LWQ·December 22, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 17, 2014

    PKG, DEBANEY FORCEPS, P/N 0250080314. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023