10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MINICON CONCENTRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110676·SILICONE SLEEVES PACK OF 6
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110652·COAXIAL IRR-ASP TIP 45 DEG W/ SILICONE
GRAFT, COOLEY WOVEN VASCULAR, STERILE
FDA 510(k)
FDA Class 2
·Cardiovascular
SUPERCATH 6
FDA 510(k)
FDA Class 2
·General Hospital
STYLE 15 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·July 9, 2021
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
UNKNOWN·Product code IKX·September 26, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·December 19, 2013
ANEURX XPEDIENT BIFURCATED STENT GRAFT (FLEXIBLE)
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 14, 2010
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025