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

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    INTRAVASCULAR ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Zavation

    FDA UDI
    Zavation LLC·00197157004217·K-wire, Blunt/Threaded, Blunt/Threaded

    Zavation

    FDA UDI
    Zavation LLC·00197157004248·K-wire, Sharp/Smooth, Blunt/Threaded

    Zavation

    FDA UDI
    Zavation LLC·00197157004231·K-wire, Sharp/Threaded, Blunt/Threaded

    Zavation

    FDA UDI
    Zavation LLC·00197157004224·K-wire, Blunt/Smooth,Blunt/Threaded

    Zavation

    FDA UDI
    Zavation LLC·00197157004255·K-wire, Blunt/Smooth, Blunt/Smooth/ Length 22.000

    Zavation

    FDA UDI
    Zavation LLC·00197157004262·K-wire, Blunt/Smooth, Blunt/Smooth/ Length 18.898

    STRAITH NASAL SPLINT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    7410 Ultrasound System (MyLabSigma)

    FDA 510(k)
    FDA Class 2 ·Radiology

    SCREWDRIVER SHAFT, COMPRESSION T2 TIBIA 3.5 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HXX·July 27, 2012

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 24, 2014

    ACCURUS 800CS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 29, 2010

    ALARIS PCA MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP.·Product code FPA·November 14, 2012

    3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 24MM

    FDA Adverse Event
    Injury ·SYNTHES BETTLACH·Product code KTT·April 29, 2015

    Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014