BEUDAMED
    14 results · 38ms · Sources: EU EUDAMED, US FDA

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    DRESSSKIN

    FDA 510(k)
    FDA Unclassified ·Unknown

    PEACE OF MIND HOME DRUG TEST

    FDA 510(k)
    FDA Unclassified ·Unknown

    BREAST-BOARD (MULTIPLE)

    FDA 510(k)
    FDA Class 2 ·Radiology

    INNOVA 4100

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·April 4, 2011

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 28, 2025

    INNOVA 4100

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·May 6, 2011

    TSRH® SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·July 5, 2016

    TSRH® SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·July 5, 2016

    MRH KNEE FEM S LFT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code KRO·March 27, 2013

    LIGASURE ADVANCE PISTOL GRIP

    FDA Adverse Event
    Malfunction ·COVIDIEN LP, (VALLEYLAB)·Product code GEI·February 15, 2011

    PALIND 19/36 SLOT KIT W/VT

    FDA Adverse Event
    Other ·TYCO HEALTHCARE/KENDALL·Product code MPB·March 20, 2008

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP60

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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024