BEUDAMED
    12 results · 20ms · 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.
    Filters Regulation: Us FDA ×

    QUICKVUE INFLUENZA A + B TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00531461·

    MicroAire®

    FDA UDI
    Microaire Surgical Instruments LLC·00847399005458·SST TAP, 4.5mm Dia., 3.2mm DRILL, 4.5mm SCREW

    CLINIFLO INCENTIVE SPIROMETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VIATRONIC V3D CALCIUM SCORING

    FDA 510(k)
    FDA Class 2 ·Radiology

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·November 5, 2012

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·April 11, 2013

    ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 3.5 MM - STANDARD

    FDA Adverse Event
    Injury ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GDW·May 16, 2008

    CONCERTO II CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NIK·April 13, 2011

    SYNERGY

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 3, 2014

    AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 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