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

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    IWL2020 Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Infinity Internal Hex System

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950004645·infinity INTERNAL 3.7x11.5MM Ø3.5HD HEX IMPLANT...

    ScrewPlus® Implant

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307105428·3.7mmD x 11.5mmL, 4.7mmD Platform

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114025·HYDRO-DISSECT FLAT J-SHAPED 27GA (PK/10)

    XLP - Toyota - Black - XLPouch

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588030111·XLP - Toyota - Black - XLPouch

    Arena-C

    FDA UDI
    SPINEFRONTIER, INC.·00190361023166·Arena-C HA, 11X17 Straight, 11mm

    DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 30, 2025

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·October 14, 2022

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·October 14, 2022

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 9, 2008

    CAPSUREFIX NOVUS

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

    AUTOLUBE-III

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GEI·July 3, 2013

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·March 25, 2025

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 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

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018