11 results
·
26ms
·
Sources: EU EUDAMED, US FDA
LANCER PLASTIC TRANSFER PIPETTE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772412471·PROTECT.LUMBOSTYLE BACK SUPPORT BLACK I
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110560·COAXIAL IRRIGAT-ASPIRAT TIP STR 0.4 PORT
Ortho Specialties
FDA UDI
Young Innovations, Inc.·00843471186886·Bicuspid Bands, Lower, Size 21
SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015-
FDA 510(k)
FDA Class 2
·Microbiology
SIGNAPioneer
FDA 510(k)
FDA Class 2
·Radiology
IFUSE IMPLANT SYSTEM
FDA Adverse Event
Injury
·SI-BONE, INC.·Product code OUR·January 27, 2021
LIFESTENT SOLO VASCULAR STENT SYSTEM
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code NIP·September 19, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 19, 2013
TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·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