BEUDAMED
    9 results · 26ms · 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 ×

    TENS&EMS units (SM9109A, SM9109B)

    FDA 510(k)
    FDA Class 2 ·Neurology

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180156272·MULTI - FLEX LONG RETRACTOR ARM (LONG FLEX ARM)...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776190989·Long Retractor Arm

    ANKYLOS DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CYLOS VR

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code DXY·November 20, 2008

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 9, 2011

    SECURE 3 MED/SURG BEDOBS 01/13

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 22, 2013

    PKG, 5MM X 45CM, INSERT, METZENBAUM CURVED SCISSORS, LONG JAW, P/N 0250080752 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