21 results · 22ms · Sources: EU EUDAMED, US FDA

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NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER

FDA 510(k)
FDA Class 2 ·Neurology

CART 9733856 S7 STAFF ASSEMBLED 110V

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 4, 2019

STEALTHSTATION® S7´

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 20, 2019

CART 9733856 S7 STAFF ASSEMBLED 110V

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 17, 2019

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B167311314250·

TALOS° HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B167321314250·

VuMesh™

FDA UDI
Seaspine Orthopedics Corporation·10889981036683·End Cap (10mm Cage) 14mm, 2.5 Deg

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613069803·Tenotomy Scissors, Curved, Left Handed, Overall...

GENTLEWAVES LED PHOTOMODULATION DEVICE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES

FDA 510(k)
FDA Class 2 ·Microbiology

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014

COOK TPN DOUBLE LUMEN TPN CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code DQO·May 9, 2013

SCREW-IN

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

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

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

CDI Blood Parameter Monitoring System 500 with Arterial and Venous 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

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