8 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MiroCam Capsule Endoscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305
FDA 510(k)
FDA Class 2
·General Hospital
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014
STERLING ES PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·July 21, 2011
MEDEX SMALL BORE EXTENSION SET
FDA Adverse Event
Injury
·SMITHS MEDICAL MD, INC.·Product code FPA·June 10, 2013
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026