BEUDAMED
    251 results · 13ms · Sources: EU EUDAMED, US FDA

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    Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.

    FDA Recall
    Completed ·Exactech, Inc.·Product code LZO·June 29, 2021

    illumina Model NextSeq 550 Dx REF 20005715

    FDA Recall
    Completed ·Illumina, Inc.·Product code PFF·May 3, 2022

    Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.

    FDA Recall
    Completed ·Medtronic Inc.·Product code NIP·November 20, 2023

    Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tray Trial, Cat. #321-00-11; (4) HAT LAT Right Tray Trial, Cat. #321-00-12; (5) HAT EXT LAT Left Trial, Cat. #321-00-21; and (6) HAT EXT LAT Right Trial, Cat. #321-00-22. The Humeral Augmented Tray is designed to function with the Equinoxe Reverse Shoulder System orthopedic implant components.

    FDA Recall
    Completed ·Exactech, Inc.·Product code PHX·May 11, 2021

    Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.

    FDA Recall
    Completed ·Exactech, Inc.·Product code LZO·June 29, 2021

    illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx

    FDA Recall
    Completed ·Illumina, Inc.·Product code PFF·May 3, 2022

    MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.

    FDA Recall
    Completed ·Illumina, Inc.·Product code PFF·April 5, 2023

    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.

    FDA Recall
    Completed ·Caire, Inc.·Product code CAW·October 4, 2024

    nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System

    FDA Recall
    Completed ·Nuwellis Inc·Product code KDI·December 11, 2024

    Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code: 0010206

    FDA Recall
    Completed ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·December 22, 2005

    Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 7.7'' x 9.7'' (19.6cm x 24.6cm) Code: 0010208

    FDA Recall
    Completed ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·December 22, 2005

    Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 10.8'' x 13.7'' (25.4cm x 33cm) Code: 0010207

    FDA Recall
    Completed ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·December 22, 2005

    Bard Composix Kugel Hernia Patch- Large Oval with ePTFE , 5.4'' x 7.0'' Product Number: 0010202

    FDA Recall
    Completed ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·January 10, 2007

    Bard Composix Kugel Oval, 6.3'' x 12.3'' for hernia repairs Product Code: 0010209

    FDA Recall
    Completed ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·December 22, 2005

    Bard Composix Kugel Hernia Patch- Large Circle 4.5'' with ePTFE Product Code: 0010204

    FDA Recall
    Completed ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·January 10, 2007

    Bard Composix Kugel Large Circle, 4.5'' for hernia repairs Product Code: 0010204

    FDA Recall
    Completed ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·December 22, 2005

    Bard Composix Kugel Large Oval, 5.4'' x 7'' for hernia repairs Product Code: 0010202

    FDA Recall
    Completed ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·December 22, 2005

    A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.

    FDA Recall
    Completed ·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·Product code LCP·September 18, 2024

    PTS Panels CHOL+GLU Test Strips (REF 1765)

    FDA Recall
    Completed ·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·Product code CGA·August 16, 2022

    Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850

    FDA Enforcement
    Class II ·Completed·Beckman Coulter, Inc.·July 23, 2025