8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
TOTAL PROTEIN SET, ITEM NO. 64010
FDA 510(k)
FDA Class 2
·Clinical Chemistry
C5 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
SUSPENSION SALINE, API 20E
FDA 510(k)
FDA Class 1
·Microbiology
TOTAL ASR ACET IMP SIZE 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·April 25, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·June 29, 2007
LOCKTI PANGEA LOCKING CAP
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