11 results
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30ms
·
Sources: EU EUDAMED, US FDA
COAT-A-COUNT TESTOSTERONE RIA KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Mini Twin
FDA UDI
Rmo, Inc.·00885797652805·ROTH MINI LOW PROFILE 022 HK/3 5-5 20EA
K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ORTHO-1(NOT FINALIZED)
FDA 510(k)
FDA Class 2
·Dental
COBAS E 411 IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·March 15, 2021
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. REG. # 8010379·Product code JDI·May 15, 2014
ATTAIN OTW
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
RSVR MMT-326A 10PK PRDGM 1.8ML 13L
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FMF·August 20, 2010
NAVITOR TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code NPT·June 27, 2023
FLEXNAV DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code NPT·June 27, 2023
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021