12 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Starlight Imaging Catheter
FDA 510(k)
FDA Class 2
·Radiology
Symmetry Weitlaner-Beckmann
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482061404·Symmetry® Retractor, Weitlaner-Beckmann, Sharp,...
HORICO
FDA UDI
Hopf, Ringleb & Co. GmbH & Cie.·EHORFG2430162·Rotary diamond instrument
Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 20, 2008
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
IMUFLEX DISPOSABLES
FDA Adverse Event
Malfunction
·TERUMO CORPORATION/TERUMO BCT·Product code CAK·July 23, 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
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 28, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025