8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ORTHO RESULT PLUS/PREGNANCY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690197935·AK3 PS-C Insert Trial Size 4, 20mm
MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
MANNITOL-SALT AGAR USP PLATE
FDA 510(k)
FDA Class 1
·Microbiology
TENDRIL DX
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·June 25, 2014
FLEXICAP DISCONNECT CAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·November 9, 2010
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·December 27, 2012
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025