22 results
·
22ms
·
Sources: EU EUDAMED, US FDA
SONOTT FLOWLAB(R)
FDA 510(k)
FDA Class 2
·Cardiovascular
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317337290·
Handgrips HNS, set/2
FDA UDI
MACROMEDICS B.V.·08720168162908·
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365107771·
Data Logger Bravo (T)
FDA UDI
Scican Ltd·07540196002394·Data logger for Bravo Chamber Autoclave
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321117300·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311117300·
ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE
FDA 510(k)
FDA Unclassified
·Unknown
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
SERIES A PAT THN 34 3 PEG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 28, 2020
ARTHREX SUREFIRE SCORPION
FDA Adverse Event
Malfunction
·ARTHREX·Product code MFJ·May 8, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·June 2, 2011
TALENT ABDOMINAL BIFURCATED STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·August 14, 2008
VGXP XP E1 TIB BRG RL 10X71
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·November 27, 2019
VGXP XP E1 TIB BRG RM 10X71
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·November 27, 2019
HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINER
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code KWZ·September 26, 2016
VGXP INTLK FEMORAL RT 67.5
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·November 27, 2019
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·August 12, 2016
XP-XP Tibial Tray - Interlok 75 mm Item # 195757
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018