11 results
·
17ms
·
Sources: EU EUDAMED, US FDA
AVL OPTI 1 PH/BLOOD GAS ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799004215·
Ambler Surgical
FDA UDI
AMBLER SURGICAL CORP.·10190660199989·MICS Slit knife, 1.1mm wide, angled blade, full...
C-STEM
FDA UDI
DEPUY (IRELAND)·10603295235187·C-STEM Stem SIZE 1 9/10 TAPER CEMENTED
BLOOD PRESSURE METER, MODEL CH-311B
FDA 510(k)
FDA Class 2
·Cardiovascular
67-8006 DARLING-LINTON AORTIC TOURN.
FDA 510(k)
FDA Class 1
·Cardiovascular
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC·Product code FNL·January 17, 2013
STENOSCOP
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·January 11, 2011
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 15, 2014
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025