13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Instylla Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Life Instruments
FDA UDI
Life Instrument Corporation·M9307191731010·Triangular Endplate Scraper 11mm, 9" Handle
MOLECULAR BREAST IMAGING SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
AMSCO EVOLUTION MEDIUM STEAM STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·May 31, 2018
BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·May 18, 2018
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014
CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·August 4, 2011
TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX
FDA Adverse Event
Malfunction
·INVACARE·Product code ITI·October 30, 2015
BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·March 8, 2022
BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·December 10, 2019
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020