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

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    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code OTE·June 11, 2025

    Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code LGD·May 30, 2025

    Hintermann Series Talar Implant, Left, Size 2 REF 302112

    FDA Recall
    Open, Classified ·DT MedTech, LLC·Product code NTG·March 24, 2026

    Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK, REF DYNJ49404C; d) CT BIOPSY, REF DYNJ52666C; e) BIOPSY KIT, REF DYNJ61130B; f) ASPEN SOFT TISSUE PACK, REF DYNJ63165B; g) BIOPSY TRAY FOAKS, REF DYNJ63575A; h) CUSTOM SOFT TISSUE PACK, REF DYNJ66347A; i) KWIK PACK, REF DYNJ67926B; j) ESI TRAY, REF DYNJ68261B; k) LARGE BIOPSY PACK NTX, REF DYNJ68393A; l) LOOP KIT, REF DYNJ84129

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFG·September 4, 2024

    MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available with SILTEX Textured or smooth surface shells. Each implant is supplied sterile with a disposable fill tube and reflux valve.

    FDA Recall
    Open, Classified ·Product code FWM·September 30, 2021

    medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024

    medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024

    medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024

    medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024

    medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024

    smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024

    medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024

    medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024

    medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024

    medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024

    medex Arterial Kit 1/EA, Product Code REF MX7827

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024

    medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024

    medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024

    medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024

    medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024