BEUDAMED
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    Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems, Catalog Number A16972

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·January 15, 2025

    Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·December 18, 2024

    Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.

    FDA Enforcement
    Class II ·Ongoing·Future Diagnostics Solutions B.V.·February 1, 2023

    Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·November 5, 2025

    MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.

    FDA Enforcement
    Class II ·Ongoing·Medical Information Technology, Inc.·September 24, 2025

    VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·January 11, 2023

    CareLink Clinic, REF: MMT-7350

    FDA Enforcement
    Class II ·Ongoing·Medtronic MiniMed, Inc.·December 3, 2025

    MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

    FDA Enforcement
    Class II ·Ongoing·PATH·December 24, 2025

    AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP

    FDA Enforcement
    Class II ·Ongoing·PATH·December 6, 2023

    SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098

    FDA Enforcement
    Class II ·Ongoing·PATH·December 6, 2023

    SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S

    FDA Enforcement
    Class II ·Ongoing·PATH·December 6, 2023

    SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2

    FDA Enforcement
    Class II ·Ongoing·PATH·December 6, 2023

    Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)

    FDA Enforcement
    Class II ·Ongoing·Nova Ortho-Med Inc·December 30, 2020

    a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests. Model Number: 5002. b. McKesson Consult Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Urine Sample 25 Tests Model Number: 5000. c. McKesson Medical-Surgical McKesson TEST KIT, PREG HCG CASSETTE WAIVED Model Number: 5001

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022

    OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem

    FDA Enforcement
    Class II ·Ongoing·Oxoid Australia Pty Limited·April 8, 2026

    Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12

    FDA Enforcement
    Class II ·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023

    Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19

    FDA Enforcement
    Class II ·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023

    Multichem P, Part Code 08P90-10

    FDA Enforcement
    Class II ·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023

    Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G

    FDA Enforcement
    Class II ·Ongoing·Ellex Medical Pty Ltd.·July 5, 2023

    Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory components (Disposable EEG Wires, WaterTabs, WaterTabs Application Kit, and Take-home Kit).

    FDA Enforcement
    Class II ·Ongoing·SEER MEDICAL PTY LTD·September 25, 2024