11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS.
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·November 13, 2017
EPLEY OMNIAX
FDA 510(k)
FDA Unclassified
·Unknown
Captura® Disposable Hot Biopsy Forceps
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·June 13, 2014
COBAS INTEGRA CALCIUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CIC·October 18, 2010
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·December 11, 2012
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·May 17, 2021
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 11, 2017
CAPTURA HOT BIOPSY FORCEPS
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code KGE·December 2, 2024
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026