BEUDAMED
    24 results · 25ms · Sources: EU EUDAMED, US FDA

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    Shear Wave Quantificational Ultrasound Diagnostic System

    FDA 510(k)
    FDA Class 2 ·Radiology

    GERALD TISSUE FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896060166·GERALD TISSUE FORCEPS STRAIGHT MICRO TIP

    Drill Guide

    FDA UDI
    Treace Medical Concepts, Inc.·00810111222143·Drill Guide and Template

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776376970·Cushing Vein Retractor 11", blade 13mm x 11.5mm

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306804960·Cerkes Micro Osteotome, 2mm

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780165293·Integra® Jarit® Cushing Vein Retractor, 11-1/4"...

    Initia Total Hip System

    FDA UDI
    KYOCERA CORPORATION·04547898307294·STDHO LINER 32-52/54

    VISUALINE BARBITURATES DIPSTRIP TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AI-ECG Tracker

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    aap Implantate AG·04042409080081·Cortical Screw 2.0, L 36

    Widex

    FDA UDI
    Widex A/S·05706069883053·WIDEX MOMENT MRB2D (Deep Blue ) Telecoil, RIC 3...

    Widex

    FDA UDI
    Widex A/S·05706069744439·WIDEX EVOKE EBB3D (Deep Blue ) Telecoil, RC coi...

    NA

    FDA UDI
    aap Implantate AG·04042409080098·Cortical Screw 2.0, L 36

    SMR SHOULDER

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code MBF·December 7, 2023

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 15, 2008

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 10, 2011

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 1, 2013

    VACUETTE TUBE 3.5 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75 BLUE CAP-BLACK

    FDA Adverse Event
    Malfunction ·GREINER BIO-ONE NA INC·Product code GIM·September 23, 2020

    LAPIPLASTY SYSTEM S4A

    FDA Adverse Event
    Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code HRS·March 14, 2025

    Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 1, 2025