BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    INSPIRATION VENTILATOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58210515500·

    Ophthalmic Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668106068·COLIBRI FORCEPS WITH PLATFORM

    DEROYAL INDUSTRIES, INC.

    FDA registration
    DEROYAL INDUSTRIES, INC.·6 products·🇺🇸 United States

    PrimeStore MTM

    FDA UDI
    Longhorn Vaccines And Diagnostics, LLC·B90305151·PrimeStore MTM 5 ml tubes with 1.5 ml fill in 5...

    HCG STAT PAK ULTRA-FAST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACUMATCH GXL 15DEG LINER 36MM SZ J

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·April 19, 2024

    LIFESHIELD LATEX FREE SYMBIQ PUMP SET

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 16, 2012

    UNK

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·February 23, 2011

    UNK

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·July 1, 2010

    UNK

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·January 7, 2011

    ADAPTA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·April 10, 2013

    GENTLE THREADS ROUND HEAD SCREW

    FDA Adverse Event
    Malfunction ·ARTHROTEK/BIOMET, INC.·Product code HWC·May 16, 2008

    EON RECHARGEABLE IPG

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION DIV·Product code LGW·April 7, 2011

    2710 CLEARTRACE LT

    FDA Adverse Event
    Other ·CONMED CORPORATION·Product code GXY·April 13, 2007

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024