36 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Natus Quantum
FDA 510(k)
FDA Class 2
·Neurology
MAESTRO TOTAL WRIST
FDA UDI
Biomet Orthopedics, LLC·00880304439061·
Maestro™ Total Wrist
FDA UDI
Biomet Orthopedics, LLC·00887868239557·
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014584·PedFuse Respond, SLD, 5.0mm x 45mm
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014577·PedFuse Respond, SLD, 5.0mm x 40mm
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014553·PedFuse Respond, SLD, 5.0mm x 30mm
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014560·PedFuse Respond, SLD, 5.0mm x 35mm
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014591·PedFuse Respond, SLD, 5.0mm x 50mm
MODIFICATION TO GALILEO GOLD
FDA 510(k)
FDA Class 2
·Anesthesiology
LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM
FDA 510(k)
FDA Unclassified
·Unknown
PLUM A+
FDA Adverse Event
Malfunction
·HOSPIRA INC·Product code FRN·April 10, 2013
PLUM A+
FDA Adverse Event
Malfunction
·HOSPIRA INC·Product code FRN·April 10, 2013
PLUM
FDA Adverse Event
Malfunction
·HOSPIRA·Product code FRN·April 10, 2013
ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·May 1, 2019
HEARTSTART XL+ DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 4, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
FLEXIMA ALL PURPOSE DRAINAGE CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FFA·September 29, 2008
VARIABLE LOCK SCREW 4.75X15MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWJ·January 24, 2018
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