9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
U.S. MEDICAL PS-2000 PEDIATRIC SCALE
FDA 510(k)
FDA Class 1
·General Hospital
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756364072·DR WYATT'S E-PACK
ACON STREP A RAPID TEST STRIP
FDA 510(k)
FDA Class 1
·Microbiology
VALO CORDLESS
FDA 510(k)
FDA Class 2
·Dental
STREP A RAPID TEST STRIP (THROAT SWAB)
FDA Adverse Event
Death
·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code GTY·March 25, 2024
COMPRESSION ANASTOMOSIS RING (CAR 27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·November 19, 2010
1.8MM TI LOCKING SCREW
FDA Adverse Event
Death
·SYNTHES USA·Product code KWQ·July 2, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 3, 2012
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021