9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dolphin Blue Imaging
FDA 510(k)
FDA Class 2
·Radiology
DELTA SHOULDER
FDA 510(k)
FDA Class 2
·Orthopedic
NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 27, 2023
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code KRD·January 2, 2023
HANDSWITCH PENCIL
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·August 17, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·November 3, 2014
UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 11, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025