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

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    BAHA DIVINO

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Ophthalmic Scissors

    FDA UDI
    KATENA PRODUCTS, INC.·00841668105184·TERRY MICRO CORNEAL SCISSORS LEFT

    VARISEED 7.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    RHIGENE MESACUP-2 TEST RNP, MODEL M7741

    FDA 510(k)
    FDA Class 2 ·Immunology

    UNKNOWN COOL TIP ELECRTRODE

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·March 6, 2020

    UNKNOWN COOL TIP ELECRTRODE

    FDA Adverse Event
    Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·March 3, 2020

    Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Product Usage: Chromophare surgical lights are medical lights for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations. The Chromophare surgical lights consist of a ceiling tube, SK Box swivel arm support, and a light head. The light head is mounted on a cardanic suspension unit and can be turned, swiveled and tilted in any direction. The spatial repositioning of the light head makes use of the 360 degree rotating swivel/horizontal arm. The 360 degree rotating spring arm is used to adjust the height. The light can be mounted in several configurations, such as a single/dual ceiling mount, a boom-integrated suspension mount, a wall mount, or a mobile roll stand.

    FDA Enforcement
    Class II ·Terminated·Stryker Communications·March 7, 2018

    UNKNOWN CLOSUREFAST CATHETER

    FDA Adverse Event
    Injury ·COVIDIEN·Product code GEI·April 2, 2013

    ENDOTAK RELIANCE G

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 6, 2011

    OPTUNE

    FDA Adverse Event
    Injury ·NOVOCURE GMBH·Product code NZK·October 18, 2018

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·March 17, 2017

    640G INSULIN PUMP MMT-1712K

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 18, 2022

    FUSION NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·August 7, 2018

    BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553. Intended to be used only for the flushing of indwelling vascular access devices.10 mL BD PosiFlush Normal Saline Flush Syringes are generally compatible for use with syringe pumps.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·October 1, 2014

    COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile

    FDA Recall
    Terminated ·Epimed International·Product code OGE·July 24, 2017

    TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only

    FDA Recall
    Terminated ·Epimed International·Product code OGE·July 24, 2017

    MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58

    FDA Recall
    Terminated ·Product code HTO·August 4, 2017

    RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter

    FDA Recall
    Terminated ·Epimed International·Product code OGE·July 24, 2017

    PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code LJT·December 4, 2017