BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300

    FDA 510(k)
    FDA Class 2 ·Hematology

    HairCheck-DT (Opiates)

    FDA UDI
    Quest Diagnostics·00868586000223·HairCheck-DT (Opiates) is an ELISA test kit use...

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809868111·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND CLOSED...

    12Pin 3/5-Lead ECG Host Cable,ESU-P

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904004457·

    REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PLATELETWORKS

    FDA 510(k)
    FDA Class 2 ·Hematology

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·March 31, 2016

    XMAX MOTOR

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code ERL·April 2, 2013

    AU643-02 CHEMISTRY ANALYZER

    FDA Adverse Event
    BECKMAN COULTER MISHIMA K.K.·Product code JJE·April 6, 2011

    VITALITY DS

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

    PKG, 5MM INSERT, MARYLAND DISSECTING FORCEPS, CURVED LEFT, 45CM, P/N 00250080578 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

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 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