11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP
FDA 510(k)
FDA Class 2
·Ophthalmic
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984573·anteriors; shade C4; mould 92 S
HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891
FDA 510(k)
FDA Class 1
·Hematology
SCANLISA HUMAN CRP ELISA KIT
FDA 510(k)
FDA Class 2
·Immunology
DAILIES TOTAL 1
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code LPL·August 3, 2012
DAILIES TOTAL 1
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·July 19, 2012
FORTIFY ASSURA DR, DF4 CONNECTOR
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·February 28, 2013
ASR UNI FEMORAL IMPL SIZE 41
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 28, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 6, 2014
DAILIES TOTAL 1
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·November 9, 2012
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024