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

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    VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776295783·Large Curette

    Richard-Allan® Needle Straight Cutting

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00840113219018·Intent to be used with suture material for tiss...

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506087646·CURETTE; LARGER, 11" (28CM), CUP (18.8MM X 14MM)

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134120·Trial, TLIF, 27L OB STR 7Deg, 12mm

    NA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295091639·SHARP CURETTE LARGE

    AT HOME DRUG TEST, MODEL 9069

    FDA 510(k)
    FDA Unclassified ·Unknown

    TARGET DETACHABLE COIL

    FDA 510(k)
    FDA Class 2 ·Neurology

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 25, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 16, 2011

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 9, 2013

    a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55

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

    Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026