BEUDAMED
    16 results · 71ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SEXTANT SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code MCV·October 29, 2009

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code LXH·December 10, 2010

    MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MISONIX IRRIGATION SYSTEM MOEDL BC20P

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SEXTANT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·October 1, 2010

    5.0MM TI LOCKING SCREW 38MM- FOR IM NAILS-STERILE

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HWC·August 12, 2016

    11.0MM TI HELICAL BLADE 90MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HSB·August 12, 2016

    10MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM ¿ STERILE

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HSB·August 12, 2016

    ZIMMER AIR DERMATOME II COMPLETE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code GFD·April 12, 2013

    SIGMA 8000

    FDA Adverse Event
    Injury ·SIGMA INTERNATIONAL·Product code FRN·June 19, 2008

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 19, 2011

    BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Company·July 27, 2022

    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

    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