7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ISOBAR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RISE SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 15, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 2, 2015
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026