BEUDAMED
    20 results · 31ms · Sources: EU EUDAMED, US FDA

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    SP-1PSpecular Microscope

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550162·GENUMEDI PT KNEE SUP SILVER L EW VII

    LACTOSORB* 1.5MM SYSTEM TEMPLATE

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036076887·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694016773·MFx 125 Degree Angulated Locking Contoured Reco...

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·October 28, 2025

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·November 23, 2025

    BD SYRINGE 50ML LL TIP 1ML

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 24, 2025

    VARIOUS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZOLL M SERIES ETC02 LOFLO OPTION

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    2.4MM RECONSTRUCTION, 14 HOLE STRAIGHT LOCKING

    FDA Adverse Event
    Malfunction ·OSTEOMED·Product code JEY·May 1, 2014

    SMITHS MEDICAL PORTEX SPINAL TRAY (KIT)

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL / ICU MEDICAL, INC.·Product code CAZ·December 1, 2025

    SMITHS MEDICAL, PORTEX SPINAL TRAY (KIT)

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL / ICU MEDICAL, INC.·Product code CAZ·December 1, 2025

    SMITHS MEDICAL, PORTEX SPINAL TRAY (KIT)

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL / ICU MEDICAL, INC.·Product code CAZ·December 1, 2025

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·October 5, 2014

    PELVICOL ACELLULAR COLLAGEN MATRIX

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·April 24, 2013

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    FDA Adverse Event
    Malfunction ·CORDIS CORPORATION·Product code NTE·June 28, 2011

    2.4MM RECONSTRUCTION PLATE - 14 HOLE

    FDA Adverse Event
    Injury ·OSTEOMED·Product code JEY·December 18, 2017

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·February 5, 2025

    Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024