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

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    OMNILUX PLUS

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    n/a

    FDA UDI
    Ortho Development Corporation·00822409074235·10/12 Broach 13x17

    TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    RENEW LS-1

    FDA 510(k)
    FDA Class 2 ·Dental

    EPD 60000 RPM

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·June 27, 2017

    FLEXTEND

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·April 9, 2013

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 25, 2011

    ENDOTAK RELIANCE G

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·March 1, 2016

    DRILL BIT Ø1.8 F/MATMAND L125 2FLUTE F/0

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code DZI·September 3, 2013

    CABLE 3M TO CONSOLE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 16, 2014

    PKG, 3MM X 29CM INSERT, DISSECTING FORCEPS, P/N 0250282110 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    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

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024