9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
WHEELCHAIR PATIENT RESTRAINTS
FDA 510(k)
FDA Class 1
·Physical Medicine
CODMAN® HAKIM®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780534938·CODMAN® HAKIM® Precision Fixed Pressure Valve, ...
DIGITAL ELECTROCARDIOGRAPHS
FDA 510(k)
FDA Class 2
·Cardiovascular
CANON FULL AUTO TONOMETER TX-F
FDA 510(k)
FDA Class 2
·Ophthalmic
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 2, 2014
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE-2.5
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GDW·December 12, 2007
GLOBAL ADVANTAGE STEM 12 MM
FDA Adverse Event
Injury
·DEPUY SUZHOU·Product code KWS·November 8, 2012
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024