BEUDAMED
    21 results · 32ms · Sources: EU EUDAMED, US FDA

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    Surgical Mask

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

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707037002·EDGEWISE DB BRACKET 22 KIT

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112809·BARRON VACUUM PUNCH 8.75MM

    APEX Base - Light Pink - 3kg

    FDA UDI
    Sprintray, Inc.·00850070544412·SprintRay Apex Base resin is a light-curable po...

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112960·CORNEAL TREPHINE BLADE8.75MM

    CARRIAZO BARRAQUER II MICROKERATOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MODIFICATION TO TENOR SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·March 9, 2007

    TENOR SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·December 27, 2010

    INTRACRANIAL KIT 110-4BT

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES·Product code GWM·October 16, 2008

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 5, 2011

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·June 28, 2013

    TENOR SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·December 27, 2010

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code NIP·March 28, 2022

    OT ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 23, 2016

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIU·June 2, 2021

    BLOOD PUMP PU VALVES 30 ML, IN/OUT 9 MM

    FDA Adverse Event
    Malfunction ·BERLIN HEART GMBH·Product code DSQ·March 31, 2021

    ALINITY I ESTRADIOL REAGENT KIT

    FDA Adverse Event
    Malfunction ·A.I.D.D LONGFORD·Product code CHP·January 28, 2022

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012