7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
VELKET TOURNIQUET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MS SYSTEM (NARROW RIDGE)
FDA 510(k)
FDA Class 2
·Dental
Knotless SutureTak Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HLTHCARE CORP·Product code FRN·January 3, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 10, 2012
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 26, 2007
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