BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03

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

    ZESPIN SI Joint Fusion System

    FDA UDI
    Aegis Spine, Inc.·00840273321590·Locking Screw Ø8x55mm

    ENDER NAIL

    FDA UDI
    Smith & Nephew, Inc.·03596010104366·3.5MM DIAMETER NAIL X 25CM ...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694021357·FPS 3.5mm x 24mm Locking Screw

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694075749·FPS 3.5 x 24mm Locking Screw Sterile Qty 2

    MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·July 15, 2011

    ACUSNARE POLYPECTOMY SNARE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·July 3, 2013

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026