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

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    I.T.S. Hand Locking Plates System - HLS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551057285·Nasal Olive, metal, 18 cm

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694016780·MFx 125 Degree Angulated Locking Contoured Reco...

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973101840·Poly Insert MPCS, Size 4L, 18mm

    REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·February 4, 2016

    LUER-LOK

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·March 9, 2026

    IOLMASTER 500

    FDA Adverse Event
    Malfunction ·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·October 14, 2015

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·December 1, 2015

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 5, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·June 3, 2013

    TRIDENT 0 DEG CONSTRAINED INSERT 28G

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code KWZ·June 21, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035; d) 4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040; e) 2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025; f) 3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030; g) 3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035; h) 4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040; i) 4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045; j) 5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050; k) 5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024