45 results · 22ms · Sources: EU EUDAMED, US FDA

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Surgical Face Mask (HNFM0304)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PROGRAMALITH #'S 221, 222, 221A & 222A

FDA 510(k)
FDA Class 3 ·Cardiovascular

TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

LAD, MODEL LAD-01

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

QUICKVUE AT-HOME OTC COVID-19 TEST

FDA Adverse Event
Malfunction ·QUIDELORTHO CORPORATION·Product code QKP·August 21, 2024

QUICKVUE AT-HOME OTC COVID-19 TEST

FDA Adverse Event
Malfunction ·QUIDELORTHO CORPORATION·Product code QKP·August 20, 2024

BINAXNOW COVID-19 ANTIGEN SELF-TEST

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·June 14, 2022

BINAXNOW COVID-19 ANTIGEN SELF TEST

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 15, 2021

BINAXNOW COVID-19 ANTIGEN SELF-TEST

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 13, 2022

BINAXNOW COVID-19 ANTIGEN SELF-TEST

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 13, 2022

AIRLIFE 2025 EDITION BROSELOW TAPE 36-2446 REV. 3

FDA Adverse Event
Other ·SUNMED GROUP HOLDINGS, LLC DBA AIRLIFE·Product code OKI·November 18, 2025

BINAXNOW COVID-19 SELF-TEST

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QKP·July 15, 2022

BINAXNOW COVID-19 ANTIGEN SELF-TEST

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·June 13, 2022

BINAXNOW COVID-19 SELF -TEST

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 6, 2021

BINAXNOW COVID-19 ANTIGEN SELF TEST

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 13, 2022

8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

FDA Adverse Event
Injury ·ST. JUDE MEDICAL·Product code MGB·November 4, 2008

APEX¿

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·August 24, 2011

SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE

FDA Adverse Event
Injury ·ETHICON INC.·Product code GDW·July 11, 2013

BINAXNOW COVID-19 ANTIGEN SELF-TEST

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 15, 2021

CVS HEALTH AT HOME, COVID-19 TEST KIT

FDA Adverse Event
Malfunction ·QUIDELORTHO CORPORATION·Product code QKP·August 7, 2024