8 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PREFORMED TOOTH POSITIONER
FDA 510(k)
FDA Class 1
·Dental
Archon
FDA UDI
Nuvasive, Inc.·00887517204806·Archon Screw, 4.5x19mm Self-Tap Var
Bongo
FDA 510(k)
FDA Class 2
·Dental
RADIO IMMUNO ASSAY KIT/
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 10, 2012
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 27, 2007
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 3, 2013
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