BEUDAMED
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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 Enforcement
    Class II ·Ongoing·BioReference Health, LLC·December 20, 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 Enforcement
    Class II ·Ongoing·BioReference Health, LLC·June 14, 2023

    IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·November 20, 2024

    PSA Test

    FDA Enforcement
    Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

    ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025

    CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implantable medical devices used to treat arrhythmias related to bradycardia, and cardiac resynchronization therapy (CRT)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·May 12, 2021

    Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450

    FDA Enforcement
    Class II ·Ongoing·Davol, Inc.·August 2, 2023

    Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: No

    FDA Enforcement
    Class II ·Ongoing·Medistim Asa·November 5, 2025

    Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.

    FDA Enforcement
    Class II ·Ongoing·Newport Corp·June 12, 2024

    COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·February 11, 2026

    Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).

    FDA Enforcement
    Class II ·Ongoing·Remote Diagnostic Technologies Ltd.·July 7, 2021

    Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495

    FDA Enforcement
    Class II ·Ongoing·Kreatech Biotechnology Bv·December 4, 2024

    Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1

    FDA Enforcement
    Class II ·Ongoing·Busse Hospital Disposables, Inc.·December 7, 2022

    Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1

    FDA Enforcement
    Class II ·Ongoing·Busse Hospital Disposables, Inc.·December 7, 2022

    Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219

    FDA Enforcement
    Class II ·Ongoing·DeRoyal Industries Inc·July 12, 2023

    Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c) SUTURE REMOVAL KIT, Product Code SR60555; d) SKIN STAPLE REMOVER, Product Code TRI44105

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 10, 2024

    BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.

    FDA Enforcement
    Class II ·Ongoing·Breg Inc·November 15, 2023

    Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014

    FDA Enforcement
    Class II ·Ongoing·DeRoyal Industries Inc·July 12, 2023

    Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.

    FDA Enforcement
    Class II ·Ongoing·Tornier S.A.S.·May 14, 2025

    Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.

    FDA Enforcement
    Class II ·Ongoing·Centinel Spine, Inc.·May 13, 2026