13 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ENDOSCOPIC NEEDLEHOLDER, MODIFICATION
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
CTXA Hip Extended Reference Data
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DICTXAHIPEXTDB0·The CTXA Hip Extended Reference Data is an acce...
Nexxis
FDA UDI
Barco NV·05415334002180·MNA-440 ENC HDMI
Nexxis OR
FDA UDI
Barco NV·05415334002371·MNA-440 DEC HDMI
Nexxis OR
FDA UDI
Barco NV·05415334002647·MNA-440 ENC SDI
N/A
FDA UDI
Tyber Medical, LLC·M695M9303300·
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
CTXA HIP EXTENDED REFERENCE DATA
FDA 510(k)
FDA Class 2
·Radiology
RANGE SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 21, 2013
RESTORE PRIME
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·November 24, 2010
530G INSULIN PUMP
FDA Adverse Event
Death
·MEDTRONIC MINIMED·Product code OZO·July 11, 2014