15 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SteriTite Container System with MediTray Products
FDA 510(k)
FDA Class 2
·General Hospital
VERIDIAN
FDA UDI
VERIDIAN HEALTHCARE LLC·00845717000536·ProKit Aneroid Sphygmomanometer With Dual-Head ...
Plateau-C Ti
FDA UDI
Life Spine, Inc.·00190837067281·Custom Small Anatomical Spacer, 7degree, 11mm
DISPOSABLE POWDER FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
FACIAL SPA
FDA 510(k)
FDA Class 2
·Neurology
IOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
MITEK BIOKNOTLESS RAPIDE (BR) W/ORTHOCORD
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MAI·June 8, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·October 22, 2008
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 12, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 9, 2013
MITEK BIOKNOTLESS RAPIDE (BR) W/ORTHOCORD
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MAI·June 8, 2013
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026