11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PURITAN-BENNETT NASAL CPAP MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
LightStim for Acne/ LightStim for Acne Mini
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MULTI-DRIP INFUSION CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
PORTEX BLUSELECT TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code BTO·February 6, 2023
MALLINCKRODT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code BTR·August 17, 2016
AMPLATZER MUSCULAR VSD OCCLUDER
FDA Adverse Event
Malfunction
·AGA MEDICAL CORPORATION·Product code MLV·March 1, 2020
AMPLATZER TORQVUE DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·AGA MEDICAL CORPORATION·Product code DQY·March 1, 2020
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·December 22, 2010
ADVANCE(R) TOT COND FEMORAL NON-POROUS
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JWH·February 4, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code ITI·July 17, 2014
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