BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    ClearCorrect System

    FDA 510(k)
    FDA Class 2 ·Dental

    ambIT* Cassette - Filter, Spike

    FDA UDI
    Avanos Medical, Inc.·00193494001155·ambIT* Cassette - Filter, Spike

    ambIT

    FDA UDI
    SUMMIT MEDICAL PRODUCTS, INC.·00857595005046·Cassette - Filter, Spike

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154029891·SCREWDRIVER BLADE

    Finsen Retractor

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896108301·Finsen Retractor With Adjustment Screw 3 X 4 Sh...

    Adler Instrument Company

    FDA UDI
    Adler, Inc.·00810123201549·MAYO-HEGAR NH 7-1/4 GROOVED JA

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361035954·FENESTRATED SCREW, CANNULATED, Ø10MM x 40MM, SA...

    LINK Instruments - Saw and drill guides

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575341436·Orthopaedic implant aiming/guiding block, reusa...

    AMBIT

    FDA Adverse Event
    Malfunction ·SUMMIT MEDICAL PRODUCTS, INC.·Product code FRN·December 20, 2022

    VOXAR'S CALCIUM SCORING PRODUCT

    FDA 510(k)
    FDA Class 2 ·Radiology

    FOCUS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONE TOUCH BASIC ENHANCED

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·August 7, 2002

    AVANOS AMBIT CASSETTE WITH SPIKE CONNECTOR

    FDA Adverse Event
    Injury ·AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)·Product code OFQ·August 21, 2024

    RECAP HIP

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWA·November 3, 2014

    ENDOPATH** XCEL* TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·August 23, 2011

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013

    ambIT Ambulatory Infusion Pump Cassette; Filter, Spike, Sterile, Vol. 2.3ml, REF 220140, Sorenson Medical, Inc., West Jordan, Utah.

    FDA Recall
    Terminated ·Sorenson Medical, Inc.·Product code FRN·October 10, 2006

    INFUSOMAT

    FDA Adverse Event
    Death ·B. BRAUN MELSUNGEN AG·Product code FRN·January 10, 2019

    VAPR S90 ELECTRODE 4.0MM, 90° SUCTION W/INTEGRATED HANDPIECE

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code GEI·September 12, 2016

    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