9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
GEMTAB SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Snowden-Pencer
FDA UDI
STERIS CORPORATION·10885403181788·DIAMOND-FLEX 90 DEG ARTICULATING FORCEPS ATRAUM...
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756595872·ACDF PACK
UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PROFILE URODYNAMIC MONITORING SYS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 25, 2014
CELL-DYN 3700 SL ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·November 9, 2010
OASYS BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWP·December 27, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020