8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
IRON SET, ITEM NO. 65008
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
PART NO. 66-00311
FDA 510(k)
FDA Class 2
·Anesthesiology
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 25, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 29, 2007
LO7.0MM TI PANGEA POLYAXIAL SCR DUAL CORE/ 50MM
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·September 28, 2012
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025