7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
ID BRACLETS, ADULT & INFANT
FDA 510(k)
FDA Class 2
·General Hospital
AURALAY PIT & FISSURE SEALANT
FDA 510(k)
FDA Class 2
·Dental
Single Use Electrosurgical knife
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·October 3, 2012
PLATE/ROD CUTTER
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HTZ·April 24, 2014
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 5, 2008
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024