BEUDAMED
    20 results · 31ms · Sources: EU EUDAMED, US FDA

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    RetroFix

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPERATING SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896054608·OPERATING SCISSORS CURVED SHARP/BLUNT TIPS POWE...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694006361·2.4mm Locking Screw Visidisk (Green)

    Drill Guide

    FDA UDI
    Treace Medical Concepts, Inc.·00810111223393·Drill Guide and Template

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319721650·Ballenger Swivel Knife 7-3/4" (19.4cm), 5mm wid...

    Sonoma™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981050795·Sonoma Anterior Cervical Plate 2 Level Plate, 26mm

    SCANLAN®

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159018462·Tangential Occlusion Clamp

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780165330·Integra® Jarit® Ribbon Retractor, 13", 64mm Wid...

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306823411·Maltz Rasp, Up Cutting: 18cm/7in

    XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·September 28, 2021

    Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·March 8, 2023

    AXS VECTA 074 CATH 132CM - CE

    FDA Adverse Event
    Injury ·STRYKER NEUROVASCULAR-CALIF·Product code QJP·July 24, 2024

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·October 22, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 1, 2013

    SMR REVERSE HUMERAL BODY SHORT

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code PHX·January 17, 2023

    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

    MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

    FDA Enforcement
    Class III ·Terminated·Invivo Corporation·October 28, 2020