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

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    Dynex Micro

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112823·BARRON VACUUM PUNCH 9.25MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112724·BARRON VACUUM PUNCH 6.75MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112885·CORNEAL TREPHINE BLADE6.75MM

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·August 28, 2020

    INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code HQL·October 16, 2008

    SECURA DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code LWS·August 11, 2011

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 2, 2013

    ALINITY I PROCESSING MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·February 7, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 13, 2022

    REMSTAR AUTO

    FDA Adverse Event
    Injury ·PHILIPS / RESPIRONICS, INC.·Product code MNS·January 11, 2022

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·May 19, 2023

    MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)

    FDA Enforcement
    Class II ·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023

    Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·February 12, 2014

    Various products which were contract sterilized.

    FDA Enforcement
    Class II ·Ongoing·Anewmed Corporation·November 6, 2019

    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