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

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    APNEA RISK EVALUATION SYSTEM (ARES)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Screw Fastener Holding Forceps

    FDA UDI
    Osteocentric Technologies, Inc.·00816950028601·Screw Fastener Holding Forceps

    HemoCue® Glucose 201 Microcuvettes

    FDA UDI
    Hemocue AB·17311091107050·HemoCue Glucose 201 Microcuvettes 4x25 single

    BD INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015

    Ormco

    FDA UDI
    ORMCO CORPORATION·00889989028515·SS BROAD ARCH LO SML 0210X0250 PK/10

    Leva® Anterior Expandable Spacer System

    FDA UDI
    Spine Wave, Inc.·10840642109245·Spacer, 30 mm (W) x 28 mm (D) x 15 mm (H), 8° L...

    Biliary Drainage Tube

    FDA UDI
    OLYMPUS MEDICAL SYSTEMS CORP.·04953170046599·

    ZYNO Z-800 INFUSION SYSTEM MODEL Z-800

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OPTIDOS

    FDA 510(k)
    FDA Class 2 ·Radiology

    MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT - 20 FR - PULL

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code KNT·October 27, 2021

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·June 1, 2011

    TOSHIBA Kalare Diagnostic X-Ray System K110785

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·July 17, 2013

    TOSHIBA Kalare Diagnostic X-Ray System K110785

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013

    VENTAK PRIZM AVT model no. 1900, Atrial and Ventricular Therapies. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code LWP·July 25, 2005

    HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. Affected lots identified initially were 110705, 110706, 110715, 110716, 110717, 110718, 110719, and 110720. Subsequent investigation also identified as affected lots 1310227, 1310252, and 1310257. HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CGA·October 20, 2014

    HemoCue Glucose 201 Microcuvettes, Article Number:110705*,110706,110715**,110716**,110717**,110718**, 110719** " No affected lots of this article have been delivered to customers. Still in stock at distributor HemoCue Inc. "" Article not available in US Quantitative determination of glucose in whole blood, using a specially designed analyzer, the HemoCue Glucose 201 Analyzer. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels. HemoCue Glucose 201 Microcuvettes are for In Vitro Diagnostic use only and are only to be used with the HemoCue Glucose 201 Analyzer. For professional use only.

    FDA Recall
    Terminated ·Hemo Cue, Inc.·Product code CGA·May 30, 2011

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. Affected lots identified initially were 110705, 110706, 110715, 110716, 110717, 110718, 110719, and 110720. Subsequent investigation also identified as affected lots 1310227, 1310252, and 1310257. HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials.

    FDA Enforcement
    Class II ·Terminated·Radiometer America Inc·December 31, 2014