10 results
·
39ms
·
Sources: EU EUDAMED, US FDA
U.S. MEDICAL PS-3000 NEONATAL SCALE
FDA 510(k)
FDA Class 1
·General Hospital
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756364423·CMC POSTERIOR HIP PACK PGYBK
UCR
FDA UDI
Seaspine Orthopedics Corporation·10889981080020·Tap, 5.5mm
AMBU GEL, HYDROGEL BURN DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
SENSITITRE OPTIREAD
FDA 510(k)
FDA Class 2
·Microbiology
ATUNE REV RP TIB BASE SZ 8 CEM
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code NJL·December 20, 2019
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 11, 2013
COMPRESSION ANASTOMOSIS RING (CAR 27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·November 19, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 2, 2014
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