10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
RESUBMITTED ABBOTT TESTPACK ROTAVIRUS
FDA 510(k)
FDA Class 1
·Microbiology
Sasmar Classic
FDA UDI
Sasmar Pharmaceuticals SPRL·09337213008211·PERSONAL LUBRICANT
TruMatch Graft Cage - Long Bone
FDA 510(k)
FDA Class 2
·Orthopedic
MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
HS III PROXIMAL SEAL SYSTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·April 9, 2014
AIR DERMATOME HANDPIECE
FDA Adverse Event
Malfunction
·ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS·Product code GFD·October 1, 2010
CANCELLOUS SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code DZL·December 20, 2012
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·May 24, 2023
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020