BEUDAMED
    11 results · 26ms · 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 ×

    FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STINGRAY ORIENTING BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·October 1, 2014

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 17, 2013

    SIGMA 100 VVI

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011

    Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·September 5, 2018

    KYOCERA MEDICAL TECHNOLOGIES, INC.

    FDA Adverse Event
    Malfunction ·KYOCERA MEDICAL TECHNOLOGIES, INC.·Product code OVD·December 21, 2021

    Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.

    FDA Recall
    Terminated ·Medline Industries Inc·Product code NGT·February 1, 2018

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019