7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
URIC ACID REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDOSCOPIC CAMERA TC804/C4
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·January 14, 2013
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 1, 2010
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 3, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015