11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
RUSCH EMERGENCY MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
artegral life
FDA UDI
Merz Dental GmbH·D7091993528·anteriors; shade BL1; mould CL
NONE
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code UNK·December 11, 2009
Empty EVA Bag
FDA 510(k)
FDA Class 2
·General Hospital
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963
FDA 510(k)
FDA Class 2
·Cardiovascular
TENOR SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWQ·December 11, 2009
TRUFILL DCS ORBIT MINI COMPLEX FILL
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code HCG·March 7, 2013
COLLEAGUE SINGLE CHANNEL CXEPUMP V1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 16, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·August 8, 2014
UNKNOWN SPIRALOK ANCHOR
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MBI·June 21, 2007
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