BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    ROYALE AE 9036 LSP INJECTOR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    THREADED ROD

    FDA UDI
    Biomet Orthopedics, LLC·00887868005817·

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193105154·HA PEEK EVOS Curved, , 10mmx11mmx 30mm , BICONV...

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0130100·Plate Holder

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0130100·Segmental Rod Reducer Assembly

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 12, 2021

    SNIFF POSITION PILLOWS/POPITZ PILLOWS

    FDA 510(k)
    FDA Class 2 ·Dental

    SPIRIT ACUPUNCTURE NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 6, 2013

    LENSAR LASER SYSTEM -FS 3D

    FDA Adverse Event
    Other ·LENSAR INC·Product code OOE·September 2, 2014

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·April 21, 2011

    XP-XP Tibial Tray - Interlok 79 mm Item # 195758

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012