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

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    KENSEY NASH ECM SURGICAL PATCH

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

    Wisp

    FDA UDI
    Respironics, Inc.·00606959021273·Wisp Mask, Fabric Frame, with Headgear, Interna...

    SIMPLICITY STARPLUS SOFT INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00

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

    PFC*SIGMA/RD/DOME PAT 3PEG,32

    FDA Adverse Event
    Injury ·9616671 DEPUY (IRELAND)·Product code JWH·May 6, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    FDA Adverse Event
    Other ·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·April 29, 2011

    Wisp and Wisp Youth Nasal Mask

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·October 12, 2022

    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