14 results
·
28ms
·
Sources: EU EUDAMED, US FDA
CENTRICELL(TM)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293241·
BR2000 BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919100676·K7-1290-47
Brasseler
FDA UDI
Provision·B504OMK71290500·
Brasseler
FDA UDI
Provision·B504OMK71290470·
BR2000 BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919100683·K7-1290-50
NA
FDA UDI
STERILMED, INC.·10888551007498·SAW BLADE OSCILLATING AGGRESSIVE CUT LARGE BONE
NA
FDA UDI
STERILMED, INC.·10888551016131·SAW BLADE OSCILLATING AGGRESSIVE CUT LARGE BONE
Vela RX PTA Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
CONTACT COMPOUNT SONOLAY. SAC-10A
FDA 510(k)
FDA Class 2
·Radiology
E360 VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 15, 2014
ACCUSOL 35 5000ML (DRUG) (UK,IRELAND,POLAND,CZECH REP.,SLOV
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CASTLEBAR·Product code KPO·October 15, 2010
CORAIL2 STD SIZE 14
FDA Adverse Event
Injury
·DEPUY FRANCE S.A.S.-SAINT PRIEST·Product code KWA·December 13, 2012
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025