8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
EASY-TEST LACTIC ACID (LA)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BIOMOVE 5000 SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
B1005, ACUCISE ENDOPYELOTOMY SYSTEM
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code EYB·April 17, 2017
CODEMASTER SL+
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code LDD·May 29, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 25, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 20, 2012
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