8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SETUP WALKER OVER TOILET CONSTRUC.
FDA 510(k)
FDA Class 1
·Physical Medicine
DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
gammaCore-2
FDA 510(k)
FDA Class 2
·Neurology
VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code LJE·January 2, 2025
DYNESYS HA PEDICLE+SET SCREW 6.0X40
FDA Adverse Event
Other
·ZIMMER GMBH·Product code NQP·March 25, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·October 4, 2012
DELTA CER HEAD 12/14 36MM +8.5
FDA Adverse Event
Injury
·DEPUY INTL, LTD.·Product code KWA·July 22, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021