9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DURHAM; LUER LOCK EXTENSION SET
FDA 510(k)
FDA Class 2
·General Hospital
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515238206·Halle Elev, sm, 7 1/4"
ACCOUSONIC PLUS, MODEL AP-170
FDA 510(k)
FDA Class 2
·Physical Medicine
DENTAL UNIT WITH CHAIR
FDA 510(k)
FDA Class 1
·Dental
CENTURION VISION SYSTEM
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·January 23, 2013
GENESIS II
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC., BROOKS MANUFACTURING SITE·Product code JWH·December 16, 2010
SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIP·July 11, 2014
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system
FDA Enforcement
Class II
·Ongoing·Barco N.V.·July 2, 2025
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system
FDA Recall
Open, Classified
·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code DXJ·May 9, 2025