11 results
·
27ms
·
Sources: EU EUDAMED, US FDA
HEPARIN PUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ceramill
FDA UDI
Amann Girrbach AG·E4947610501·
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110638·COAXIAL IRR-ASP TIP STR W/SILICONE 0.3MM
Daytona® Small Stature
FDA UDI
Seaspine Orthopedics Corporation·10889981149680·Precontoured Rod, 4.5 x 50mm
GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACTABOND Topical Skin Adhesive
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HELIX BLADE 100MM
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·August 12, 2020
LIBERTY CYCLER SET, SINGLE CONN./ EXT. DL
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·April 11, 2014
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 26, 2012
MAXIMOVE
FDA Adverse Event
Other
·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·July 8, 2010
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025