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

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    Rocket Platinum Cured Cathter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIORAPTOR

    FDA UDI
    Smith & Nephew, Inc.·03596010511737·BIORAPTOR 6 INCH X 4 MM DRILL GUIDE SPIKED TIP ...

    Cradle, Sonalis-NG

    FDA UDI
    Best Nomos·00852656007489·The Sonalis-NG Cradle is device which is used t...

    Zavation

    FDA UDI
    Zavation LLC·00842166132214·Ti3Z CIF 13mmx15mmx9mm -5 deg

    ZAVATION

    FDA UDI
    Zavation LLC·00842166104303·CIF 13x15, 5 deg, -09

    VIDAS SARS-COV-2 IGM

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code QKO·April 14, 2021

    EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908

    FDA 510(k)
    FDA Class 2 ·Neurology

    CEDARS-SINAI BPGS AND MOCO

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·February 2, 2021

    BD DISCARDIT¿ II SYRINGE WITH DETACHED BD MICROLANCE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·May 22, 2023

    TECNIS

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·August 12, 2011

    SHILEY 5.0PED

    FDA Adverse Event
    Injury ·Product code BTO·October 22, 2008

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013

    VIDAS SARS-COV-2 IGM

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code QKO·October 21, 2020

    VIDAS SARS-COV-2 IGM

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code QKO·June 29, 2020

    TRUERESULT

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·July 10, 2017

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

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

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020