8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
FDA 510(k)
FDA Class 2
·Cardiovascular
artegral life
FDA UDI
Merz Dental GmbH·D7091993531·anteriors; shade BL1; mould BXL
ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CUFF SPECULUM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·March 7, 2013
SPECTRAFLEX
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
SEGURA HEMISPHERE STONE RETRIEVAL BASKET
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FFL·February 16, 2011
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024