13 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
FDA 510(k)
FDA Class 2
·Cardiovascular
THERMO SCIENTIFIC MAS OMNI-CORE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCU-CHEK ACTIVE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·January 15, 2026
AEQUALIS REVERSED II DISPOSABLE DRIVER TIP
FDA Adverse Event
Malfunction
·TORNIER SAS·Product code HSD·May 7, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·June 2, 2011
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 12, 2008
VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·May 25, 2023
VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·June 1, 2023
VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·May 9, 2023
VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·April 5, 2023
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025