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

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    SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Snowden-Pencer

    FDA UDI
    STERIS CORPORATION·10885403152771·Snowden-Pencer DIAMOND-TIP OSTEOTOMES SHEEHAN 1...

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011884035220·dentaform® Band, Tooth 46, Size 35/Roth 22

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867129283·LO-PRO SCRW,SS 4.0X 35MMCANCLUS

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011884035180·dentaform® Band, Tooth 46, Size 35/Roth 18

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011884035000·dentaform® Band, Tooth 46, Size 35

    MENSTRUAL PADS

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    UNIVERSAL SELF-ALIGNING ACETABULAR COM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    JUMAO MEDICAL EQUIPMENT·Product code IOR·June 19, 2014

    TURBOVAC 90 3.5MM 90 DEG. SUCTION

    FDA Adverse Event
    Injury ·ARTHROCARE CORP.·Product code GEI·October 14, 2010

    BIOFINITY TORIC COMFILCON A

    FDA Adverse Event
    Injury ·COOPERVISION MANUFACTURING LIMITED·Product code LPM·December 21, 2012

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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