12 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SmartClip Soft Tissue Marker
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500
FDA 510(k)
FDA Class 2
·General Hospital
M5 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
LOCKING SCREW, FULLY THREADED 5X55 MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 30, 2010
ARROR STIM CPNB TUOHY NDL: 18G X 4CM (1-1/2")
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code BSP·September 8, 2014
ARROW STIM CPNB TUOHY NDL: 18G X 4CM (1-1/2")
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code BSP·September 8, 2014
ARROW STIM CPNB TUOHY NDL: 18G X 4CM (1-1/2")
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code BSP·September 8, 2014
SONICFILL COMPOSITE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EBF·June 20, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014
HEARTMATE II SYSTEM CONTROLLER, EU
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·May 5, 2011
TREK¿
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code LOX·January 7, 2026
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018