BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Affixus Tibial Nailing System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Oticon A/S·05707131282316·H16V2 TI, BTE 13 WL 85 SIL

    SYNGO BODY PERFUSION-CT

    FDA 510(k)
    FDA Class 2 ·Radiology

    STERI-DENT, STERI-SURE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·October 8, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITI·June 6, 2013

    AUGMENTED INSERT

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 29, 2011

    DIVA

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·July 7, 2020

    DIVA

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·July 7, 2020

    A7 ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017

    SENRI

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code DQY·December 25, 2016

    VERSE POLY DRIVER SHAFT NAV

    FDA Adverse Event
    Malfunction ·DEPUY SPINE INC·Product code OLO·April 29, 2022

    METACROSS RX PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·October 15, 2019

    iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015