55 results · 64ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Cell Resuspension and Preservative Solution

FDA UDI
IMMUCOR GTI DIAGNOSTICS, INC.·10888234500599·For Use with PakAuto

1062336-2016-00002

FDA Adverse Event
Injury ·May 27, 2016

BINAXNOW COVID-19 AG CARD

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

AOSEPT PLUS/CLEAR CARE

FDA Adverse Event
Injury ·CIBA VISION CANADA, INC., STERILE MANUFACTURING (CVSM)·Product code LPN·April 19, 2010

BINAX NOW COVID-19 AG CARD

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 28, 2021

SUREPATH® PRESERVATIVE FLUID COLLECTION VIAL

FDA Adverse Event
Injury ·TRIPATH IMAGING, INC.·Product code LEA·May 27, 2016

RNA MEDICAL HEMATOCRIT CONTROL LEVEL 3

FDA Adverse Event
Other ·BIONOSTICS, INC.·Product code CGA·May 1, 2006

TRIMA ACCEL

FDA Adverse Event
Malfunction ·TERUMO BCT·Product code GKT·April 8, 2025

I-STAT CONTROL LEVEL 3

FDA Adverse Event
Other ·BIONOSTICS, INC.·Product code CGA·April 24, 2006

HEALONID

FDA Adverse Event
Injury ·PHARMACIA & UPJOHN, FYRISLUND·Product code LZP·February 20, 2004

BINAXNOW COVID-19 AG CARD

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QKP·March 18, 2022

BINAXNOW COVID-19 ANTIGEN SELF TEST

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 25, 2021

BINAXNOW COVID-19 AG CARD

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QKP·March 30, 2022

BINAXNOW COVID-19 AG CARD

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 21, 2022

BINAXNOW COVID-19 AG CARD

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

BINAXNOW COVID-19 AG CARD

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 20, 2022

BINAXNOW COVID-19 AG CARD

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 1, 2021

BINAXNOW COVID-19 AG CARD

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QKP·November 21, 2021

BINAXNOW COVID-19 AG SELF TEST

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 18, 2021

BINAXNOW COVID-19 ANTIGEN CARD

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 21, 2022