7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CEDIA THEOPHYLLINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PARALLEL DUAL LUMEN SUBCLAVIAN CANNULA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE SCHIRMERSCOP
FDA 510(k)
FDA Class 2
·Ophthalmic
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 19, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 22, 2012
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 1, 2015
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024