BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    ZIOSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108694000·Step Drill Stop for L13mm Implant, Narrow Long

    LOCATOR R-Tx, Dentsply Sirona System

    FDA UDI
    Zest Anchors, LLC·00840481137167·LOCATOR R-Tx Abutment EV (L) 5mm

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481115103·LOCATOR F-Tx Abutment for 4.8mm EV Internal Con...

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481110832·LOCATOR R-Tx Abutment for 4.2mm EV Internal Con...

    LOCATOR, Dentsply Sirona System

    FDA UDI
    Zest Anchors, LLC·00840481131745·LOCATOR R-Tx Attachment System for Abutment EV ...

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481129247·LOCATOR R-Tx Abutment, 4.8mm Astra EV Connectio...

    CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES

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

    FREESTYLE FREEDOM LITE

    FDA Adverse Event
    Injury ·Product code NBW·September 7, 2012

    COSYCOT INFANT WARMER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·March 10, 2013

    DRX-REVOLUTION MOBILE X-RAY SYSTEM

    FDA Adverse Event
    Other ·CARESTREAM HEALTH, INC.·Product code IZL·April 17, 2013

    INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·April 18, 2011

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 3, 2008

    BABY CONTROL COSYCOT INFANT WARMER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code FMT·November 8, 2015

    Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO-Trac Tacrolimus ELISA kit

    FDA Recall
    Terminated ·Diasorin Inc.·Product code MLM·April 12, 2004

    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015