BEUDAMED
    22 results · 28ms · Sources: EU EUDAMED, US FDA

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    QuikClot Control+

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

    ATLANTIS® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000889678·PLATE 7200167 ATL VISION ELITE 67.5MM

    ATLANTIS® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994625038·PLATE 7200167 ATL VISION ELITE 67.5MM

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776396534·Kelly Retractor, lamb handle, 2 1/2" x 3"

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306823282·Cottle Chisel, Straight, 6mm, 18cm

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780182221·Integra® Jarit® Kelly Retractor, 11", Lamb Hand...

    Initia Total Hip System

    FDA UDI
    KYOCERA CORPORATION·04547898307386·STDHO LINER 36-66/70

    NA

    FDA UDI
    ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024306295·

    epoc Blood Analysis System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MectaScope System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·December 1, 2000

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 28, 2025

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Other ·BECKMAN COULTER, INC.·Product code MMI·October 1, 2008

    ARCHITECT I2000 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·August 10, 2011

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 1, 2013

    SMR CEMENTLESS FINNED STEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·August 28, 2023

    PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·December 20, 2023

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·December 14, 2021

    AEH-4 LITHOTRIPSY SYSTEM

    FDA Adverse Event
    Injury ·NORTHGATE TECHNOLOGIES INC.·Product code FFK·July 10, 2019

    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

    FDA Enforcement
    Class II ·Completed·Mako Surgical Corporation·November 25, 2020