BEUDAMED
    18 results · 31ms · Sources: EU EUDAMED, US FDA

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    IN-OVATION® Mini

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551811·IN-OVATION® mini EURO 018/5-5 CS HK

    IN-OVATION® Mini

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551821·IN-OVATION® mini EURO 018/5-5 CBC HK

    RIST Cath Radial Access Long Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DISPOSABLE EYE BLADES

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896019669·DISPOSABLE EYE BLADES CASE #67

    IN-OVATION® Mini

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K191552811·IN-OVATION® mini EURO 022/5-5 CS HK

    IN-OVATION® Mini

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K191552821·IN-OVATION® mini EURO 022/5-5 CBC HK

    In-Ovation ® Mini

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807191551801·IN-OVATION® mini EURO 018/U5 UNIV -7T 0A

    PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M

    FDA 510(k)
    FDA Class 1 ·Dental

    VARI-LASE PLATINUM BRIGHT TIP LASER FIBER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 2, 2024

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    MEDEL S.P.A.·Product code BTI·June 26, 2013

    SPETZLER LUMBAR-PERITONEAL SHUNT KIT, 80CM CATH

    FDA Adverse Event
    Malfunction ·INTEGRA, ANASCO·Product code JXG·July 20, 2011

    COBAS INTEGRA 800

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·September 26, 2008

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·January 5, 2023

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·January 10, 2023

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·October 21, 2022

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018