9 results
·
29ms
·
Sources: EU EUDAMED, US FDA
CONICAST, INTRACAST, OMECAST
FDA 510(k)
FDA Class 1
·Dental
BIOMERIX ASSURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
PORTEX® BIVONA® AIRE-CUF® ADULT TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code JOH·September 1, 2016
PORTEX® BIVONA® AIRE-CUF® ADULT TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code JOH·September 1, 2016
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
GOODBABY·Product code IOR·January 13, 2013
ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code KOG·December 2, 2010
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·July 3, 2014
OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·July 4, 2018