BEUDAMED
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    THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Premium Surgiclip

    FDA UDI
    Covidien LP·20884521057521·Clip Applier

    MP Reconstruction System Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575080175·Instrument Tray, Stainless Steel, empty, L = 47...

    COVIDIEN

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FZP·June 19, 2018

    COVIDIEN

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FZP·June 22, 2018

    COVIDIEN

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FZP·June 18, 2018

    COVIDIEN

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FZP·June 22, 2018

    10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DA VINCI FLUORESCENCE IMAGING VISION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 2, 2014

    SYNCHROMED EL

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code LKK·May 29, 2013

    ASR ACETABULAR IMPLANT 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 15, 2011

    ENDO CLIP II

    FDA Adverse Event
    Malfunction ·DAVIS & GECK CARIBE LTD·Product code FZP·July 25, 2018

    PARIETEX

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION SAS·Product code FTL·October 16, 2019

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

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

    The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·December 27, 2023

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015