10 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PICA CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PRIME-DENT HEMA DESENSITIZER
FDA 510(k)
FDA Class 2
·Dental
CONTOUR LABRAL NAIL, MODEL 533520A
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 22, 2024
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
FDA Adverse Event
Malfunction
·CODMAN AND SHURTLEFF, INC·Product code HCG·June 15, 2017
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 1, 2013
G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 16, 2014
2.5CC OSTEOSTRUX OSTEOCONDUCTIVE SCAFFOLD PUTTY
FDA Adverse Event
Other
·INTEGRA, PLAINSBORO·Product code MQV·April 26, 2011
BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·July 3, 2019
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
FDA Enforcement
Class I
·Terminated·Stryker Spine·August 28, 2013