8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS
FDA 510(k)
FDA Class 1
·Microbiology
H40 BASE METAL ALLOY
FDA 510(k)
FDA Class 2
·Dental
TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG
FDA 510(k)
FDA Class 1
·Hematology
EQUINOXE REVERSE HUMERAL TRAY
FDA Adverse Event
Injury
·EXACTECH INC.·Product code KWS·June 10, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 19, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 16, 2012
Nussloch GmbH ASP6025 Tissue Processor
FDA Enforcement
Class II
·Ongoing·Leica Microsystems, Inc.·July 12, 2017
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024