14 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Avenir Complete Hip System, Size 0 Coxa Vara
FDA 510(k)
FDA Class 2
·Orthopedic
Sklar®
FDA UDI
SKLAR CORPORATION·10649111285455·WAUGH FCP CROSS SERR 8"
ELASTIC LENS
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code HQL·March 10, 2005
POGO SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM
FDA 510(k)
FDA Class 1
·General Hospital
MAXIMUS
FDA Adverse Event
Malfunction
·Product code FPA·October 7, 2008
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
GORE® DUALMESH® BIOMATERIAL
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code FTL·November 12, 2020
GORE® DUALMESH® BIOMATERIAL
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code FTL·November 12, 2020
PROAQT SENSOR
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025
PROAQT SENSOR
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025
MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018