BEUDAMED
    18 results · 18ms · Sources: EU EUDAMED, US FDA

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    C.P.R. LANDMARC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HTH®-Left 21mm

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199004150·

    EDENTA

    FDA UDI
    EDENTA ETABLISSEMENT·E312K90044510001·Dowel Pin 15 mm

    CoreLink LATERAL SCREW

    FDA UDI
    CORELINK LLC·M72590041520·LATERAL PLATE - 4 SCREW, 15MM X 20MM

    CoreLink LATERAL SCREW

    FDA UDI
    CORELINK LLC·M72590041528·LATERAL PLATE - 4 SCREW, 15MM X 28MM

    CoreLink LATERAL SCREW

    FDA UDI
    CORELINK LLC·M72590041524·LATERAL PLATE - 4 SCREW, 15MM X 24MM

    CoreLink LATERAL SCREW

    FDA UDI
    CORELINK LLC·M72590041522·LATERAL PLATE - 4 SCREW, 15MM X 22MM

    CoreLink LATERAL SCREW

    FDA UDI
    CORELINK LLC·M72590041526·LATERAL PLATE - 4 SCREW, 15MM X 26MM

    Intervertebral Body Fusion Device

    FDA UDI
    PRECISION SPINE, INC.·00840019923576·PLIF Sizer 15mm x 22mm

    Intervertebral Body Fusion Device

    FDA UDI
    PRECISION SPINE, INC.·00840019925051·Install Guide ALIF Stabilizer 15mm

    EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    35 CM BIPOLAR STEROID ELUTING LEAD

    FDA Adverse Event
    Malfunction ·GREATBATCH MEDICAL·Product code DTB·May 6, 2014

    CELL-DYN SAPPHIRE ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·January 7, 2013

    VISISTAT SKIN STAPLER

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GDT·October 27, 2010

    OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line: 900-33-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 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

    ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·May 1, 2024