BEUDAMED
    11 results · 34ms · Sources: EU EUDAMED, US FDA

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    SYNELISA PROGESTERONE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SeaSpine Spacer System - Pacifica™

    FDA UDI
    Seaspine Orthopedics Corporation·10889910058878·Pacifica Trial, 9mm x 24mm x 15mm

    SeaSpine Spacer System - Pacifica™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981058876·Pacifica Trial, 9mm x 24mm x 15mm

    FORMA-FAS-TEST

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

    IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HEARTMATE II LVAS

    FDA Adverse Event
    Death ·THORATEC CORP.·Product code DSQ·January 25, 2013

    IM REAMER SHAFT, AO FITTING, DOVETAIL 8,0X448MM

    FDA Adverse Event
    Other ·STRYKER OSTEOSYNTHESIS KIEL·Product code HTO·December 10, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 14, 2014

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 6, 2024

    Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153000020 (e) 153000030 153000030 (f) 153000050 153000050 (g) 210700050 2107050 (h) 210700102 2107102 (I) 210700202 2107202 (j) 210700302 2107302 (k) 210700402 2107402 (l) 210700502 2107502 (m) 210700602 2107602 Product Usage: Rebreathing Bag is indicated for manual patient ventilation or in connection with anaesthesia apparatus and/or patient ventilators.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical Europe Ltd·April 18, 2018

    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