7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
UREA NITROGEN (ENZYMATIC)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
THERAPEUTIC APPARATUS, DIERKER TYPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Philips IntelliVue GuardianSoftware
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 3, 2014
TRANSSEPTAL NEEDLE, BRK XS, ADULT 18 GA, 71CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·October 5, 2012
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 19, 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