BEUDAMED
    15 results · 25ms · Sources: EU EUDAMED, US FDA

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    Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707041078·ANDREWS DB BRACKET 22 KIT

    PREDICATE III GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SpineJack Expansion Kit

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THERAPY ABLATION CATHETER

    FDA Adverse Event
    Malfunction ·IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY·Product code OAD·June 25, 2010

    VDW SILVER RECIPROCATING MOTOR

    FDA Adverse Event
    Malfunction ·DENTSPLY VDW GMBH·Product code EBW·July 13, 2021

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HRS·November 11, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 10, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 23, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code LWS·August 14, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code LWS·August 14, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code LWS·August 14, 2013

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 12, 2019

    PKG, CLAW FORCEPS, P/N 0250080244. 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