9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
P.F.C. SIGMA
FDA UDI
DEPUY (IRELAND)·10603295243557·P.F.C. SIGMA TIBIAL COMPONENT ALL POLY STABILIZ...
MYOMO E100
FDA 510(k)
FDA Class 2
·Physical Medicine
VERIFY STEAM Integrating Indicator - Short
FDA 510(k)
FDA Class 2
·General Hospital
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·February 14, 2013
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 18, 2011
ARCHITECT IPTH
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code CEW·July 29, 2014
Depuy P.F.C. E Knee System, stabilized all-polyethylene tibia, Sz 2.5, 10.0 mm; Ref 96-2631.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005
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