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

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    LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134090·Trial, TLIF, 27L OB STR 7Deg, 9mm

    8001 Series Esophageal/Rectal Temperature Probe

    FDA UDI
    MEASUREMENT SPECIALTIES, INC.·H29780010634090·8001 Series Esophageal/Rectal Temperature Probe

    ELECSYS FSH CALSET II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AT HOME DRUG TEST, MODEL 9074

    FDA 510(k)
    FDA Unclassified ·Unknown

    OMNIGUIDE BEAMPATH FIBER AND ADAPTER

    FDA Adverse Event
    OMNIGUIDE, INC.·Product code GEX·October 19, 2010

    BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·September 3, 2014

    PARADYM

    FDA Adverse Event
    Malfunction ·SORIN C.R.M., S.R.L.·Product code MRM·April 12, 2013

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC·Product code GAM·April 19, 2011

    SPECTRACLEAR PULSED LIGHT SYSTEM - SPATOUCH PRO

    FDA Adverse Event
    Injury ·RADIANCY, INC.·Product code GEX·June 20, 2008

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018

    BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JCF·July 3, 2014

    2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·February 28, 2023

    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