17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONTROL SEAL
FDA 510(k)
FDA Class 2
·Dental
Biogel
FDA UDI
Bosma Enterprises·10818634023398·Biogel Surgeons 8.5 - 50 Pair/Box
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450397145·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450535745·
GYNECARE TVT EXACT CONTINENCE SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR
FDA 510(k)
FDA Class 2
·Dental
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·May 24, 2013
FREESTYLE LITE
FDA Adverse Event
Injury
·Product code NBW·September 30, 2014
ATTAIN OTW
FDA Adverse Event
Malfunction
·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
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 Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 24, 2013