BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517275837·CoRoent Large MP Trial, 8x9x23mm 8°

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0112080·Tap, 7.50mm

    InSePtion MIS Fixation System

    FDA UDI
    Kalitec Direct LLC·B07314K0112080·Rasp, 8 and 10mm

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967186658·Battalion, LLIF Trial, 6°, 18 mm Wide, 08 mm X ...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0112080·Tap, Cannulated, 6.5 mm

    DORO HEADREST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    SIII ALARM AMPLIFIER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    G7 ACETABULAR SHELL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·August 7, 2018

    BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE M 0

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·June 1, 2023

    OT PING ENHANCED METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013

    OSSEOFLEX 1.0 STEERABLE NEEDLE

    FDA Adverse Event
    Other ·OSSEON THERAPEUTICS, INC.·Product code GAA·February 23, 2011

    SOFTCLIX PLUS LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·March 11, 2008

    COCR FEMORAL BALL HEAD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·April 14, 2026

    CARELINK SMARTSYNC COMMON APP IOS

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DTC·January 9, 2025

    Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·August 22, 2018

    CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·August 22, 2018

    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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022