BEUDAMED
    22 results · 27ms · Sources: EU EUDAMED, US FDA

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    Zavation IBF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040187852·ZIRLUX ML DISC A4 98x22

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112694·BARRON CORNEAL PUNCH 9.5MM

    Greenwald Surgical Company, Inc.

    FDA UDI
    GRACE MANUFACTURING, INC.·10801334013325·STORZ S/S SPIKED ROLLER ELECTRODE Model # ...

    SMR GLENOID PEG TT SMALL-R #M

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A·Product code KWS·August 9, 2022

    FUKUDA DENSHI DYNASCOPE MODEL DS-5700

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENRAF-NONIUS SONOPULS 190 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MICROSTAAR INJECTOR CARTRIGE

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code KYB·October 15, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 10, 2011

    6.0MM TI HARD ROD 50MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·July 1, 2013

    IM REAMER, AO FITTING BIXCUT Ø8,0X480 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·April 2, 2014

    IM REAMER, AO FITTING BIXCUT Ø7,5X480 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·April 2, 2014

    IM REAMER, AO FITTING BIXCUT Ø8,0X480 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·April 2, 2014

    IM REAMER, AO FITTING BIXCUT Ø8,5X480 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·April 2, 2014

    HUMAPEN ERGO 3 ML

    FDA Adverse Event
    Injury ·ELI LILLY AND CO·Product code KZE·March 29, 2001

    WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W

    FDA Enforcement
    Class II ·Ongoing·Delta Med SpA·August 25, 2021

    Leksell GammaPlan. Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health care professional (Neurosurgeons, Radiation Therapists and Radiation Physicists) such that the desired radiation dose is provided by the Leksell Gamma Knife to a precisely defined target area within the cranium.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·October 23, 2008

    iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

    FDA Enforcement
    Class II ·Terminated·SynCardia Systems Inc.·January 9, 2013

    Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014