BEUDAMED
    27 results · 29ms · Sources: EU EUDAMED, US FDA

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    CAD/CAMouflage Milling Bock

    FDA 510(k)
    FDA Class 2 ·Dental

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5821604250·FORCEPS, RONGEUR, SURGICAL

    SSW CARBIDE ENDO SAFE END

    FDA UDI
    Ss White Burs, Inc.·D6901604252·ENDO SAFE END CARBIDE ESE-018 -5 PACK

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1104250·Tray, Base, 4.25", Arcamed

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0604250·Tray, Base, 4.25"

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1104250·Tray, 4.25 Inch Base

    HASKAL TORQUE DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GORE® TAG® THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Death ·W.L. GORE & ASSOCIATES·Product code MIH·May 9, 2016

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·February 23, 2017

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·June 6, 2018

    ENRHYTHM DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code DXY·July 13, 2011

    CONSULTA CRT-D

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2013

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·September 16, 2008

    CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 24, 2013

    CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 24, 2013

    Artis zeego, Model Number 10280959

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·February 27, 2013

    CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·February 27, 2013

    CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·February 27, 2013