7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
AXT 1400 SPOTFILM DEVICE
FDA 510(k)
FDA Class 2
·Radiology
NYLON THREADED NEEDLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Hospira Primary Sets
FDA 510(k)
FDA Class 2
·General Hospital
HENRY SCHEIN ONE STEP+ HCG URINE CASSETTE TEST
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·December 23, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 4, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 17, 2014
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020