BEUDAMED
    15 results · 20ms · Sources: EU EUDAMED, US FDA

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    MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RMO

    FDA UDI
    Rmo, Inc.·00885797100085·QUAD HELIX ASST 5

    SpineMap Go

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327412994·SpineMap Go - SOFTWARE

    SpineMap Go

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327412987·SpineMap Go - ENABLE

    PROTECTIV SAFETY BLOOD COLLECTION NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DUAL TRIGGER PIN COLLET

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·January 29, 2019

    ACCOLADE 132 SIZE 2.5

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·March 13, 2013

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·February 9, 2011

    GE OEC 2600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·February 26, 2008

    FMS FLUID MANAGEMENT SYSTEM INFLOW TUBING (FMS VUE)

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code HRX·January 30, 2023

    Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.

    FDA Enforcement
    Class II ·Terminated·Zipline Medical·March 11, 2015

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

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