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

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    VELSCOPE VX

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814541·GENUMEDI SAND SIZE III

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564030238·TOWEL PACK QUARTERFOLD

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112687·BARRON CORNEAL PUNCH 9.25MM

    SYMPHONY

    FDA UDI
    Medos International Sàrl·10705034523576·SYMPHONY OCT SYSTEM DUAL DIAMETER ROD TITANIUM ...

    SYMPHONY

    FDA UDI
    Medos International Sàrl·10705034523569·SYMPHONY OCT SYSTEM DUAL DIAMETER ROD TITANIUM ...

    VARIANT

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030SPO1020830·Trial 30x38mm, 15° Lordotic, 17mm

    COVERIS

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030CS1020830·Trial, 12.5 x 16mm, 3° Lordotic, 7mm

    SPIRA®-A Integrated

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1020830·SPIRA®-A Integrated,Trial, 30x42mm, 15° Lordoti...

    LORENZ RESORBABLE DISTRACTOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    I-STAT CARDIAC MARKER CONTROLS

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JJE·December 16, 2010

    TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code GCA·April 23, 2013

    8800

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·May 18, 2011

    UNIVERSAL DRIVER

    FDA Adverse Event
    Malfunction ·ABBOTT SPINE·Product code HXX·August 7, 2008

    PERCEPT

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·April 1, 2022

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021