7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200
FDA 510(k)
FDA Class 2
·Microbiology
Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 18, 2014
MEDFUSION 3500 SYRINGE INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD·Product code FRN·October 21, 2010
UNKNOWN DEPUY ASR SLEEVE
FDA Adverse Event
Malfunction
·DEPUY INTERNATIONAL·Product code KWA·December 20, 2012
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