10 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517570468·CoRoent Ant TLIF Ti, 13x12x34mm 8°
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113370·CLEAR CORNEA KNIFE 3.2MM (BX/5)
CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP
FDA 510(k)
FDA Class 2
·Orthopedic
TEPHAFLEX BRAIDED SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·August 1, 2006
CONCEPT SUTURE PASSER NEEDLE
FDA Adverse Event
Injury
·CONMED LINVATEC·Product code LXH·September 2, 2011
U BY KOTEX CLICK
FDA Adverse Event
Malfunction
·QINGDAO PB CO. LTD·Product code HEB·December 11, 2012
INCEPTA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·November 6, 2014
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025