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

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    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113790·AIR INJECT CANNULA 27GA 22MM

    IBM iConnect Access

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNIBLOCKER

    FDA UDI
    FUJI SYSTEMS CORPORATION·04544050123914·UNIBLOCKER is intended for one-lung ventilation...

    UNIBLOCKER

    FDA UDI
    FUJI SYSTEMS CORPORATION·04544050080965·UNIBLOCKER is intended for one-lung ventilation...

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112731·BARRON VACUUM PUNCH 7.0MM

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113608·PERIBULBAR NEEDLE 25GA 22MM

    BACT/ALERT CSR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    AMEDICA DRUG SCREEN AMPHETAMINE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·February 2, 2018

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code OYC·August 8, 2019

    ATTAIN OTW

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·September 18, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 2, 2013

    BD PLASTIPAK¿ SYRINGES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·September 12, 2022

    ALLIANCE 4 PEG LEFT AUG REAMER GUIDE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWS·December 5, 2024

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    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