BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    SMARTbase Abutment System

    FDA 510(k)
    FDA Class 2 ·Dental

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551077658·Dissector, size 3 mm, 17 cm

    ENDER NAIL

    FDA UDI
    Smith & Nephew, Inc.·03596010104472·3.5MM DIAMETER NAIL 3.5MMX35CM ...

    TRIPTER X-1 COMPACT DUET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ILAB ULTRASOUND IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SERVO-S

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·July 22, 2011

    PROGRASP FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·November 4, 2014

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 12, 2013

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    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