BEUDAMED
    16 results · 19ms · Sources: EU EUDAMED, US FDA

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    GASTROINTESTINAL CYTOLOGY BRUSH

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

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083010812·Fixed, 4 electrode, MPB, 5mm electrode spacing

    TRU® RP Cover Screw .050" Hex, 5.0 mm, Ti

    FDA UDI
    STERNGOLD DENTAL LLC·00841549107832·The TRU is a self-tapping, double thread screw ...

    MAGNIFIER LENS

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111628·

    Bone Expander

    FDA UDI
    BICON, LLC·00813110025951·3.5mm Bone Expander

    VIKING OPTIMA GUIDING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIGITAL RADIOGRAPHY MODEL CXDI-55G

    FDA 510(k)
    FDA Class 2 ·Radiology

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·January 3, 2013

    TRILOGY LONGEVITY CROSSLINKED POLY LINER

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDI·November 11, 2010

    OBTAPE TRANSOBTURATOR SLING

    FDA Adverse Event
    Injury ·MENTOR WORLDWIDE LLC·Product code OTN·June 19, 2014

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·December 28, 2018

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·May 13, 2019

    ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·June 17, 2020

    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

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026