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

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    Elite iQ PRO (M122K1)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Ultra-Care Pen Needles 32G 1/4" 100 Ct

    FDA UDI
    ARISE MEDICAL LLC·00372217006046·Insulin Pen Needle

    ULTRASONIC SCALER ELEGANCE MS-10 (25K)

    FDA 510(k)
    FDA Class 2 ·Dental

    FREELITE HUMAN LAMBDA FREE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    NEXGEN PRECOAT TIBIAL PLATE

    FDA Adverse Event
    Injury ·ZIMMER·Product code JWH·October 30, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 9, 2011

    AXERA 2 ACCESS SYSTEM

    FDA Adverse Event
    Injury ·ARSTASIS INC.·Product code DYB·July 18, 2013

    Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239

    FDA Enforcement
    Class I ·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025