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

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    EQUINOX CO2 LASER SYSTEM

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

    Osstell SmartPeg Type 55

    FDA UDI
    Osstell AB·09010522001646·ISQ Measurement Peg

    REMSTAR PRO C-FLEX

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 30, 2025

    BIPOLAR PENCIL, MODEL 3901-002, 3900-002

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

    MEDTRADE PRODUCTS ALGINATE ISLAND

    FDA 510(k)
    FDA Unclassified ·Unknown

    VDW GOLD/SILVER CONTRA ANGLE

    FDA Adverse Event
    Malfunction ·DENTSPLY VDW GMBH·Product code EGS·February 11, 2021

    ALARIS® SYRINGE MODULE SET

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·May 3, 2016

    X-SUIT NIR COVERED BILIARY METALLIC STENT

    FDA Adverse Event
    Malfunction ·MEDINOL LTD.·Product code FGE·December 27, 2017

    SECURE 3 MED/SURG BEDOBS 01/13

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 8, 2013

    OT PING ENHANCED METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 19, 2014

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·May 13, 2011

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025