7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COBAS INTEGRA REAGENT CASSETTES
FDA 510(k)
FDA Class 2
·Immunology
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
FDA 510(k)
FDA Class 2
·Cardiovascular
Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink
FDA 510(k)
FDA Class 1
·General Hospital
6.0MMTI PANGEA (TM) POLYAXIAL
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·February 26, 2013
CAPD DISCONNECT Y-SET, BULKPACK DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·February 9, 2011
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·August 5, 2014
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024