8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UMBILICAL CORD CLAMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SafetyFix EasyOut System
FDA 510(k)
FDA Class 2
·Orthopedic
AESCULAP ENDOSCOPIC CLIP SYTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 29, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·October 25, 2010
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 20, 2012
ANTI-SIPHON PCA EXTENSION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FRN·February 4, 2011
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