BEUDAMED
    10 results · 17ms · Sources: EU EUDAMED, US FDA

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    GAUZE & LAB SPONGES STERILE & NON

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DELTAVEN

    FDA UDI
    DELTA MED SPA·08032248384255·Safety I.V Catheter in PUR with closed system ,...

    KENDALL CO2NFIRM NOW CO2 DETECTOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572

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

    SCD 700 COMPRESSION SYSTEM-US

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code JOW·February 24, 2014

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·November 21, 2012

    DEPUY ASR XL FEMORAL IMP SZ 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWY·September 17, 2010

    DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572

    FDA Recall
    Open, Classified ·Delta Med SpA Via Guido Rossa 20 Viadana Italy·Product code FOZ·June 21, 2021

    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