8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
GUARDIAN, VOLUMETRIC CONTROL DELIVERY
FDA 510(k)
FDA Class 2
·General Hospital
COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
FDA 510(k)
FDA Class 2
·Anesthesiology
GLYCOSAL II HBA 1C TEST
FDA 510(k)
FDA Class 2
·Hematology
UNKNOWN GEL IMPLANTS
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·June 8, 2024
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 11, 2013
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·August 24, 2010
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