10 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Conformis Hip System
FDA UDI
Conformis, Inc.·00850268007798·BROACH, FEMORAL, SIZE 15
NA
FDA UDI
STRYKER CORPORATION·07613327058376·Insert, Maryland Dissector
TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017
FDA 510(k)
FDA Class 2
·Anesthesiology
SERIM LEUKOCYTE ESTERASE TEST STRIPS
FDA 510(k)
FDA Class 1
·Hematology
E-POLY TIBIAL BEARINGS
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·July 12, 2017
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 26, 2013
DRIVER RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MAF·April 22, 2011
RELION 1CC INS SYR 31X5/16
FDA Adverse Event
Malfunction
·TYCO HEALTHCARE/KENDALL·Product code FMF·July 17, 2008
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021