27 results
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Sources: EU EUDAMED, US FDA
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The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following information: a patient s age, previous biopsy, and digital rectal exam (DRE).
FDA Recall
Open, Classified
·BioReference Health, LLC·Product code QRF·October 31, 2023
The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following information: a patients age, previous biopsy, and digital rectal exam (DRE). Patients file (sample type, prior biopsy status, DRE status and age) are uploaded to the Specimen Processing Module (SPM). The results from the four assays are exported automatically to Lab Manager Application (B2 LIS) which automatically triggers the 4Kscore calculation when values of the four analytes are available. The 4Kscore test results are determined automatically by the validated laboratory information system algorithm calculation software.
FDA Recall
Open, Classified
·BioReference Health, LLC·Product code QRF·November 18, 2022
Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.
FDA Recall
Open, Classified
·DRE Medical Group Inc·Product code MNT·May 15, 2023
MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-758
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code DRE·January 30, 2024
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code DRE·January 30, 2024
MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code DRE·January 30, 2024
MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code DRE·January 30, 2024
B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick.
FDA Recall
Open, Classified
·Galt Medical Corporation·Product code DRE·March 27, 2025
MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-767
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code DRE·January 30, 2024
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code DRE·August 12, 2024
MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-751
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code DRE·January 30, 2024
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-775
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code DRE·January 30, 2024
MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code DRE·January 30, 2024
MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-752
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code DRE·January 30, 2024
MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-750
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code DRE·January 30, 2024
MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-774
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code DRE·January 30, 2024
MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-749
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code DRE·January 30, 2024
MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-754
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code DRE·January 30, 2024
MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-762
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code DRE·January 30, 2024
MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-776
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code DRE·January 30, 2024