9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
DENTAL EQUIPMENT PROTECTION DEVICES
FDA 510(k)
FDA Class 1
·Dental
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198994·AK3 Congruent Insert Trial Size 2, 16mm
Voxel Dosimetry v1.0
FDA 510(k)
FDA Class 2
·Radiology
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CLINITEK STATUS+
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JHI·December 2, 2019
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·October 29, 2010
UNIFY CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code NIK·January 13, 2014
DUROM HIP GENERIC
FDA Adverse Event
Other
·ZIMMER GMBH·Product code KWA·December 13, 2012
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026