16 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENDOEYE HD II
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·January 15, 2026
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
GEN4 DIRECT ACCESS
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828147903·GEN4 DIRECT ACCESS
BD VACUTAINER® NO ADDITIVE (Z) TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code FMH·August 11, 2023
BD VACUTAINER® NO ADDITIVE (Z) TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code FMH·August 10, 2023
EVERSTICK
FDA 510(k)
FDA Class 2
·Dental
GIRAFFE OMNIBED
FDA 510(k)
FDA Class 2
·General Hospital
PELVICOL 2CM X 7CM 1.0MM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE SCIENCE·Product code FTL·April 18, 2013
UNKNOWN
FDA Adverse Event
Injury
·BREG, INC.·Product code FRN·May 25, 2011
BARD
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEMS·Product code LJS·August 12, 2008
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