36 results · 53ms · 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.

BIOMERIEUX BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC.·Product code PEN·August 29, 2024

FILMARRAY® MENINGITIS/ENCEPHALITIS (ME) PANEL

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC·Product code PLO·September 6, 2024

BIOFIRE® RESPIRATORY PANEL 2.1 (RP2.1)

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC·Product code QOF·September 30, 2025

BIOFIRE ME PANEL

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC·Product code PLO·November 19, 2025

FILMARRAY ME PANEL

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC·Product code PLO·November 25, 2025

BIOFIRE® RESPIRATORY PANEL 2.1 (RP2.1)

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC·Product code QOF·September 30, 2025

BIOFIRE® RESPIRATORY PANEL 2.1 (RP2.1)

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC·Product code QOF·September 30, 2025

FILMARRAY® BLOOD CULTURE IDENTIFICATION PANEL

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC·Product code PEN·May 21, 2020

FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC·Product code PLO·January 12, 2017

BIOFIRE BCID2 PANEL

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC·Product code PAM·April 3, 2026

FILMARRAY® PNEUMONIA PANEL PLUS

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC·Product code QDS·August 23, 2024

BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC·Product code PAM·December 13, 2023

BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC·Product code PAM·December 13, 2023

FILMARRAY ® BLOOD CULTURE IDENTIFICATION (BCID) PANEL

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC·Product code PEN·March 12, 2019

FILMARRAY® MENINGITIS/ENCEPHALITIS (ME) PANEL

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC·Product code PLO·October 9, 2024

FILMARRAY® MENINGITIS/ENCEPHALITIS (ME) PANEL

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC·Product code PLO·December 13, 2024

FILMARRAY MENINGITIS/ENCEPHALITIS PANEL

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC·Product code PLO·July 3, 2018

BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC·Product code PAM·November 2, 2023

BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC·Product code PAM·December 13, 2023

BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

FDA Adverse Event
Injury ·BIOFIRE DIAGNOSTICS, LLC·Product code PAM·December 13, 2023