BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LinkSymphoKnee - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575309535·Knee tibia prosthesis trial - LinkSymphoKnee Sy...

    LinkSymphoKnee - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575309771·Knee tibia prosthesis trial - LinkSymphoKnee Sy...

    LinkSymphoKnee - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575309917·Knee tibia prosthesis trial - LinkSymphoKnee Sy...

    LinkSymphoKnee - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575309672·Knee tibia prosthesis trial - LinkSymphoKnee Sy...

    CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PlasmaBlade X 3.0S, PlasmaBlade X 4.0

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FR2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS, HEARTSTREAM·Product code MKJ·October 6, 2010

    ESTEEM

    FDA Adverse Event
    Malfunction ·ENVOY MEDICAL·Product code OAF·February 14, 2014

    ASR IMPLANT

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·December 20, 2012

    Angiotech Access Needle. A) Hawkins Blunt Needle. STERILE. Product Number: 216057, 216107, 218057, 218107, 218157. 510k K881957. Qty Dist. - 3,220. B) Winged Guidewire Introducer Needle, Guidewire Introducer Needle, and "WW" Guidewire Introducer Needle. STERILE. Product Number: BGWI1802, BGWI1902, GWI1802, GWI1802WW, GWI1902. GWI1902WW. 510k K974745. Qty Dist: - 51,625. C) Introducer Sheath Needle. STERILE. Product Number: ISN1915. 510k Exempt. Qty Dist: - 1,260. D) Co-Axial Introducer Needle, and Co-Axial Needle - Biopince. STERILE. Product Number: MCXS1408SX, MCXS1409LX, MCXS1410AX, MCXS1410MX, MCXS1410TX, MCXS1412SX, MCXS1415LX, MCXS1416AX, MCXS1609LX, MCXS1610AX, MCXS1610TX, MCXS1612SX, MCXS1615LX, MCXS1616AX, MCXS1616MX, MCXS1616TX, MCXS1808SX, MXCS1809LX, MCXS1810AX, MCXS1810TX, MCXS1812SX, MCXS1815LX, MCXS1816AX, MCXS1816MX, MCXS1816SX, MCXS1816TX, MCXS1820AX, MCXS1820LX, MCXS2009LY, MCXS2010AY, MCXS2010MY, MCXS2010TY, MCXS2012SY, MCXS2015LY, MCXS2016AY, MCXS2016MY, MCXS2016SY, MCXS2016TY, MCXS1610BP, MCXS1615BP, MCXS1810BP, MCXS1815BP, MCXS1820BP. 510k K980004. Qty Dist: - 48,448. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Access Needle

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009

    Zeiss brand IOLMaster, Version 1-5, 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