11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code GCJ·September 13, 2024
Bernafon
FDA UDI
Bernafon AG·05714464009589·BERNAFON ALPHA 7 MNR T R MSIL
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112649·BARRON CORNEAL PUNCH 8.25MM
SHORT AND LONG SOFT TISSUE ATTACHMENT
FDA 510(k)
FDA Class 2
·Orthopedic
Physiq
FDA 510(k)
FDA Class 2
·Physical Medicine
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 3, 2014
ONE TOUCH ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·November 4, 2008
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·August 24, 2011
Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.
FDA Enforcement
Class II
·Ongoing·Medagent Inc·March 6, 2024
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