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

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    UltraLight LED System

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777525·LUMBAMED PLUS FLEX PAD M SILVER V

    Anti-Jkb (JK2)

    FDA UDI
    DIAGAST·23661562105353·Blood Grouping Reagent, Anti-Jkb (Human/Murine ...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180107366·5 MM DIA., 45 CM INSULATED L-HOOK TIP ELECTRODE...

    EUROPA™ Pedicle Screw

    FDA UDI
    MIRUS LLC·00810025483005·Ø10.5 X 35mm EUROPA™ Pedicle Screw

    NA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295086680·CANAL REAMER 15.5mm DIA

    TRIFIX SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    WHISPERJECT

    FDA Adverse Event
    Malfunction ·PHARMACEUTICALS, INC.·Product code FMI·February 1, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 27, 2016

    HIGH DEFINITION LCD MONITOR

    FDA Adverse Event
    Malfunction ·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·December 26, 2022

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·October 29, 2014

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·August 8, 2011

    PROMOTE ACCEL CRT-D

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

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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