33 results · 11ms · Sources: EU EUDAMED, US FDA

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LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification

FDA Enforcement
Class III ·Terminated·LumiraDx·November 2, 2022

Mistique Infusion Catheter, K12-MIC13510, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

Mistique Infusion Catheter, K12-MIC09005, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

Mistique Infusion Catheter, K12-MIC09010, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

Mistique Infusion Catheter, K12-MIC04505, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

Mistique Infusion Catheter, K12-MIC04510, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

Mistique Infusion Catheter, K12-MIC13505, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

Mistique Infusion Catheter, MIC5-135-5-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

Mistique Infusion Catheter, MIC5-135-5-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

Mistique Infusion Catheter, MIC5-90-20-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

Mistique Infusion Catheter, MIC5-45-5-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

Mistique Infusion Catheter, MIC5-45-20-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

Mistique Infusion Catheter, MIC5-135-20-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

Mistique Infusion Catheter, MIC5-45-10-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

Mistique Infusion Catheter, MIC5-45-5-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

Mistique Infusion Catheter, MIC5-135-10-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

Mistique Infusion Catheter, MIC5-135-20-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

Mistique Infusion Catheter, MIC5-90-10-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

Mistique Infusion Catheter, MIC5-90-5-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

Mistique Infusion Catheter, MIC5-45-20-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010