8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ACROMED INTERBODY DEPTH GAUGES
FDA 510(k)
FDA Class 1
·Orthopedic
ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
A&D Medical Blood Pressure Monitors
FDA 510(k)
FDA Class 2
·Cardiovascular
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 18, 2010
NI
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·August 12, 2016
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·June 27, 2015
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
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