BEUDAMED
    23 results · 14ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Open, Classified ×

    epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code JGS·July 7, 2025

    ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code CDN·April 24, 2025

    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·September 24, 2024

    epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·June 1, 2023

    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·April 2, 2026

    epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·June 1, 2023

    Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 63368 Stat Profile Prime Plus POC Analyzer (2) PN 63369 Stat Profile Prime Plus POC Analyzer, Remanufactured P/N: 57400, 63368

    FDA Recall
    Open, Classified ·Nova Biomedical Corporation·Product code JGS·September 18, 2023

    Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57400 Stat Profile Prime Plus Analyzer (2) PN 59508 Stat Profile Prime Plus Analyzer, Remanufactured

    FDA Recall
    Open, Classified ·Nova Biomedical Corporation·Product code JGS·September 18, 2023

    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·March 19, 2025

    HIGH V+ Spinal Cement System REF T040321K

    FDA Recall
    Open, Classified ·TEKNIMED SAS Zone Industrielle Montredone 11 Rue D Apollo L'Union France·Product code NDN·December 15, 2022

    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

    FDA Recall
    Open, Classified ·Beckman Coulter Mishima K.K. 454-32 Higashino; Nagaizumi-Cho Sunto-Gun Japan·Product code JJE·July 10, 2024

    Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670

    FDA Recall
    Open, Classified ·Beckman Coulter Mishima K.K. 454-32 Higashino; Nagaizumi-Cho Sunto-Gun Japan·Product code JJE·April 30, 2025

    Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670

    FDA Recall
    Open, Classified ·Beckman Coulter Mishima K.K. 454-32 Higashino; Nagaizumi-Cho Sunto-Gun Japan·Product code CKB·April 30, 2025

    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

    FDA Recall
    Open, Classified ·Beckman Coulter Mishima K.K. 454-32 Higashino; Nagaizumi-Cho Sunto-Gun Japan·Product code JJE·June 5, 2024

    Model No. CYF-V2, VISERA Cysto-Nephro Videoscope

    FDA Recall
    Open, Classified ·Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan·Product code FAJ·December 4, 2023

    Model No. CYF-5, Cystonephrofiberscope

    FDA Recall
    Open, Classified ·Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan·Product code FAJ·December 4, 2023

    Model No. BF-XP190, EVIS EXERA III Bronchovideoscope

    FDA Recall
    Open, Classified ·Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan·Product code EOQ·December 4, 2023

    Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE

    FDA Recall
    Open, Classified ·Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan·Product code FAJ·December 4, 2023

    Model No. CYF-5R, Cystonephrofiberscope

    FDA Recall
    Open, Classified ·Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan·Product code FAJ·December 4, 2023

    Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE

    FDA Recall
    Open, Classified ·Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan·Product code FAJ·December 4, 2023