BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    TRILOGY 202 VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TRILOGY 200

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code CBK·August 19, 2020

    ACTI-ICP MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·March 26, 2024

    GORE-TEX SUTURE

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code GAW·April 26, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 16, 2014

    B/F GLENOID STRAIGHT SPOKE REAMER ASSEMBLY

    FDA Adverse Event
    Malfunction ·ZIMMER INC·Product code HTO·April 19, 2011

    1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code FZX·March 30, 2017

    Mysis Laboratory version 6.1

    FDA Recall
    Terminated ·Misys Healthcare Systems·Product code JQP·May 10, 2005

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018