16 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Life Spine SIMPACT Sacroiliac Joint Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
FREQUENCER MODEL V2X
FDA 510(k)
FDA Class 2
·Anesthesiology
RADIANCE
FDA 510(k)
FDA Class 2
·Dental
DUO-VENT CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·September 29, 2022
CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·October 31, 2022
CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 1, 2022
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 5, 2023
THE EMAX 2 PLUS SYSTEM
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 17, 2014
PROFEMUR(R) MODULAR FEMORAL NECK
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·June 20, 2013
HEARTMATE II SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORP.·Product code DSQ·May 5, 2011
CLEARLINK SOLUTION ADMINISTRATION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022
DUO-VENT CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 5, 2022
CLEARLINK SOLUTION ADMINISTRATION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022
CONTINU-FLO CLEARLINK SYSTEM SOLUTION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·December 29, 2022
Deltec Cozmo Insulin Pump, Model 1800 Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112. This Pump is similar to the currently distributed Deltec Cosmo Insulin Pump Model 1700 pump, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump. REF 21-1801-81, 21-1803-81, 21-1805-49/51/81, 21-1806-51/81, 21-1807-49
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code LZG·March 10, 2008
Deltec Cozmo Insulin Pump, model 21-1800. This is similar to the currently distributed Deltec Cozmo Insulin Pump Model 1700, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump. Reorder Numbers: 21-1801-81 21-1803-81 21-1804-81 21-1805-49/51/81 21-1806-49/51/81 21-1807-49/51/81 21-1815-01/50 21-1816-01/50 21-1817-01/50
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code LZG·February 22, 2008