10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
PRECISE PREGNANCY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471130463·K-WIRE - DOUBLE TROCAR WITH GUIDE 0.6mm DIA x 1...
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
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SIEMENS MICRO2+ WITH VAI SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
FREESTYLE LITE
FDA Adverse Event
Malfunction
·Product code NBW·January 28, 2013
ASSURE 4 BLOOD GLUCOSE SYSTEM
FDA Adverse Event
Malfunction
·APEX BIOTECHNOLOGY CORP.·Product code CGA·December 16, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 12, 2014
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015