12 results
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26ms
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Sources: EU EUDAMED, US FDA
MULTIPLE IMAGING XENON ARC AUTO LIGH SOURCE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746100017·DB BRACKET MASTER SERIES MAX LEFT LATERAL 022 T...
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746063305·DB BKT MINI MS UL LAT 022 T+14 A+8 R=0
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221112774·3M™ Victory Series™ Second Molar Bands, 905-124...
APOLIPOPROTEIN B (APO B)
FDA 510(k)
FDA Class 1
·Immunology
CHEM I CLINICAL ANALYZER URINE MAGNESIUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BD PHASEAL INJECTOR LUER LOCK N35J
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·November 14, 2019
TANDEM T:CONNECT DATA MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·May 29, 2014
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MAX·November 22, 2010
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·January 9, 2013
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024