13 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NATURAL RUBBER LATEX MALE CONDOMS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·August 14, 2015
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970379·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973578·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973394·
EPI-MAX
FDA 510(k)
FDA Unclassified
·Unknown
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE
FDA 510(k)
FDA Unclassified
·Unknown
MUSTANG?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 24, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
THERMACHOICE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code MKN·August 29, 2008
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·June 21, 2011
MUSTANG
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·May 2, 2025
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021