BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X0622350·6mm H x 22mm W x 35mm L x 0 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X062235120·6mm H x 22mm W x 35mm L x 12 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L062235120·6mm H x 22mm W x 35mm L XLIF Trial 12 degree Lo...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X06223580·6mm H x 22mm W x 35mm L x 8 degrees XLIF

    DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER

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

    HORIZONS ERCP CANNULA

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

    ADVIA CENTAUR CP HCV ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZO·March 26, 2013

    ADVIA CENTAUR XP HCV ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZO·March 26, 2013

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·April 16, 2013

    PROVISC IBC

    FDA Adverse Event
    Malfunction ·ALCON - BELGIUM/ S.A.ALCON-COUVREUR N.V.·Product code LZP·March 17, 2011

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FPO·June 17, 2008

    JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·June 16, 2021

    ADVIA CENTAUR HCV ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZO·April 12, 2013

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021