14 results · 21ms · Sources: EU EUDAMED, US FDA

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Hair Growth Device

FDA 510(k)
FDA Class 2 ·Physical Medicine

SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET

FDA 510(k)
FDA Class 2 ·General Hospital

LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

UNISOLVE WIPES

FDA Adverse Event
Injury ·SMITH & NEPHEW WOUND MANAGEMENT·Product code KOX·August 25, 2011

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
JUMAO HEALTHCARE EQUIPMENT·Product code IOR·November 4, 2014

SIG MOD TIB TRAY CEM COCR 3

FDA Adverse Event
Injury ·9616671 DEPUY (IRELAND)·Product code JWH·July 12, 2013

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 23, 2023

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 24, 2023

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 26, 2023

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 26, 2023

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 18, 2023

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 18, 2023

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025