BEUDAMED
    10 results · 15ms · 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 ×

    Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique

    FDA Recall
    Open, Classified ·Cepheid·Product code NQX·August 6, 2025

    Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10

    FDA Recall
    Open, Classified ·Cepheid·Product code OYX·October 30, 2025

    Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10

    FDA Recall
    Open, Classified ·Cepheid·Product code OYX·October 30, 2025

    Cepheid Xpert C. difficile/Epi Control Panel

    FDA Recall
    Open, Classified ·Microbiologics Inc·Product code PMN·May 16, 2019

    Cepheid, Sample Collection Device, Part: 900-0370

    FDA Recall
    Open, Classified ·Cepheid·Product code JSM·June 20, 2024

    Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only

    FDA Recall
    Open, Classified ·Cepheid·Product code PGX·April 24, 2023

    Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.

    FDA Recall
    Open, Classified ·Cepheid·Product code PEU·November 5, 2025

    Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,

    FDA Recall
    Open, Classified ·Cepheid·Product code PGX·April 24, 2023

    Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.

    FDA Recall
    Open, Classified ·Microbiologics Inc·Product code PMN·April 9, 2019

    Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.

    FDA Recall
    Open, Classified ·Microbiologics Inc·Product code PMN·April 9, 2019