11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
STERI-OSS UNTIL IMPLANT CEMENT
FDA 510(k)
FDA Class 2
·Dental
DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON
FDA 510(k)
FDA Class 2
·Immunology
Handheld VitalSigns Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·February 21, 2013
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·August 1, 2014
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 28, 2011
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·July 24, 2024
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·February 15, 2024
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·April 17, 2025
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 11, 2024
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025