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

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    MODIFICATION TO: SMITHWICK CAROTID SHUNT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·March 26, 2019

    INSORB

    FDA Adverse Event
    Other ·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008

    INSORB

    FDA Adverse Event
    Other ·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008

    INSORB

    FDA Adverse Event
    Other ·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008

    ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 27, 2013

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·June 13, 2008

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 18, 2011

    PECTUS SYSTEM JANTON 12" TI PECTUS BAR 3.048CM (12") (L) TITANIUM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 2, 2019

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015