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

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    EVERYWAY LOW BACK PAIN RELIEF SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000887971·CROSSLINK 8110716 ANTERIOR 16MM

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902844768·CROSSLINK 8110716 ANTERIOR 16MM

    Carbide burs

    FDA UDI
    DFS - DIAMON GmbH·04057176149008·Ortho carbide bur C219-O FG 1,6

    Ormco

    FDA UDI
    ORMCO CORPORATION·00889989028584·SS BROAD ARCH LO LGE 0160X0160 PK/10

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306803406·Oval Ring Small ( 13.5" X 8.5" )

    MDT Diamond Coated Dental Burs

    FDA UDI
    M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·17291046002428·FG Rotary diamond instrument for dental applica...

    MDT Diamond Coated Dental Burs

    FDA UDI
    M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·17291046002411·FG Rotary diamond instrument for dental applica...

    AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5

    FDA 510(k)
    FDA Class 2 ·Hematology

    VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·July 28, 2025

    CLAMP ASSEMBLY- 3-PIN

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·June 9, 2017

    ENDOWRIST

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·October 6, 2022

    ARTICULEZE M HEAD 36MM +8.5

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 14, 2013

    DORNIER HOMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·DORNIER MEDTECH AMERICA, INC.·Product code GEX·September 16, 2014

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·June 1, 2011

    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

    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