9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG
FDA 510(k)
FDA Class 2
·Cardiovascular
ANCHORAGE SCOPE, MODEL 000003
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
microINR System
FDA 510(k)
FDA Class 2
·Hematology
M2A-MAGNUM PF CUP 52ODX46ID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·April 28, 2026
CHEMOLOCK¿
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code ONB·February 9, 2023
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 25, 2010
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 20, 2012
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·April 9, 2014
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025