10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
EIM-107 PREP-CHECK
FDA 510(k)
FDA Class 2
·Neurology
artegral life
FDA UDI
Merz Dental GmbH·D7091993202·anteriors; shade B2; mould BL
TOY SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
EXALT Model D Single-Use Duodenoscope, EXALT Controller
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CONSULT HCG TEST
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·March 4, 2025
PULSE GEN MODEL 102
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·March 7, 2013
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·August 8, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 7, 2011
WALLSTENT? RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026