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

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    ELECTRO SENSOR -BODY COMPOSITION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Signature III

    FDA UDI
    Rmo, Inc.·00885797101662·SIG III ROTH .018, 20 BRKT KIT

    ALL SILICONE FOLEY BALLOON CATHETER

    FDA UDI
    Sewoon Medical Co., Ltd.·08806369403108·3way//Translucent 5cc 26fr

    DIAMOND WORKHORSE SCREW™, Ø3.5mm x 26mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665038286·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A103026120·10mm H x 30mm W x 26mm L x 12 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A10302680·10mm H x 30mm W x 26mm L x 8 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A103026150·10mm H x 30mm W x 26mm L x 15 degrees ALIF

    Mariner Deformity

    FDA UDI
    Seaspine Orthopedics Corporation·10889981293406·Segmental Derotation Assembly (SM)

    PFC SIGMA LUGGED TIBIAL TRAY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWDERED LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INFUSE BONE GRAFT 12 MG

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code NEK·May 1, 2014

    TGS UKA KNEE SYSTEM

    FDA Adverse Event
    Injury ·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·September 10, 2013

    COCR FEMORAL HEAD 32 S

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code LZO·August 29, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 9, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·September 19, 2014

    PREMIUM SURGICLIP S-9.0 TITANIUM

    FDA Adverse Event
    Injury ·USSC PUERTO RICO·Product code FZP·May 9, 2011

    EXCEL CONSOLE WITH FOOTSWITCH EACH1

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES (IRELAND) LIMITED·Product code LFL·March 13, 2015

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024

    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