BEUDAMED
    15 results · 27ms · Sources: EU EUDAMED, US FDA

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    Spectral Bone Marrow

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    Synthes GmbH·10886982157768·3.5MM MEDIAL DISTAL TIBIA PLATE 14 HOLES/199MM-...

    SMARTLOCK

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·34546540355905·Locking Screws, Cross-Pin

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694021302·FPS 3.5mm x 14mm Locking Screw

    Vu a-POD™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981038328·35x27mm Trial 14mm 15 deg. The Vu a-POD interve...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694075640·FPS 3.5 x 14mm Locking Screw Sterile Qty 2

    CLEARPATH ALIGNER

    FDA 510(k)
    FDA Class 2 ·Dental

    TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 4, 2014

    ENTERRPISE 9000

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH·Product code FNL·July 14, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 12, 2013

    TRANSMITTER MMT-7841ZW GST5G OUS

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code PQF·September 6, 2023

    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