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

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    Klarity SGRT System (ARSG-E1A, ARSG-E3A)

    FDA 510(k)
    FDA Class 2 ·Radiology

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 28, 2014

    IMP TM 3.7MM MTX FULL,10M

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·May 22, 2023

    TRIDENT FUSION IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RESTITU

    FDA 510(k)
    FDA Class 2 ·Radiology

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 9, 2011

    RECIPROC-SAW-ATTACHM F/TRS

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·November 10, 2014

    DEPUY ASR XL FEM IMP SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·July 22, 2013

    PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 29CM, P/N 0250282101 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