7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BIO-GIDE RESORBABLE BILAYER MEMBRANE
FDA 510(k)
FDA Class 2
·Dental
POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY)
FDA 510(k)
FDA Class 1
·General Hospital
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYMBIQ 3.13 SINGLE C
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 20, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·January 25, 2013
REMB SAG SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·December 16, 2010
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