21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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