8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BROMCRESOL GREEN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110669·COAXIAL IRR-ASP- TIP 90 DEG- W/ SILICONE
ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800
FDA 510(k)
FDA Class 2
·Immunology
TEST, RHEUM. ARTH., CARD (MACRO-VUE)
FDA 510(k)
FDA Class 2
·Immunology
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 26, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 19, 2013
UNKNOWN DEPUY SIGMA TIBIAL TRAY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 15, 2010
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025