BEUDAMED
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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO, SKU 900531

    FDA Enforcement
    Class II ·Ongoing·Family Dollar Stores, Llc.·August 24, 2022

    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography). Component: No

    FDA Enforcement
    Class II ·Ongoing·Edan Diagnostics·January 28, 2026

    WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rate Variability (HRV) Ear Clips. The system kit also incorporates use of the firm's cleared EEG analysis technology (the WAVi SCAN EEG System and Accessories, and the WAVi Headset and eSoc Single Use Electrode Contacts).

    FDA Enforcement
    Class II ·Ongoing·WAVi Co.·June 12, 2024

    HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400

    FDA Enforcement
    Class II ·Ongoing·Hamilton Co·March 10, 2021

    ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z

    FDA Enforcement
    Class II ·Ongoing·Orthorebirth Co Ltd·May 13, 2026

    One Step K in vitro diagnostic test REF: 81A4

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    One Step 10A in vitro diagnostic test

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    One Step UTI in vitro diagnostic test REF: 3374

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    Uric Acid in vitro diagnostic test REF: 31H0P

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC

    FDA Enforcement
    Class II ·Ongoing·Orthorebirth Co Ltd·May 13, 2026

    One Step pH in vitro diagnostic test REF: 31I4P

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    Portable X-ray system

    FDA Enforcement
    Class II ·Ongoing·DIGIMED CO., LTD·July 30, 2025

    LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella

    FDA Enforcement
    Class II ·Ongoing·CORENTEC CO., LTD·June 12, 2024

    LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert

    FDA Enforcement
    Class II ·Ongoing·CORENTEC CO., LTD·June 12, 2024

    QUCARE Total Cholesterol in vitro diagnostic test REF: 6407

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    One Step P in vitro diagnostic test REF: 8194

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Model/Catalog Number: 1023770 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 12 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave¿ sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·HF Acquisition Co LLC·June 17, 2026

    Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave¿ sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·HF Acquisition Co LLC·June 17, 2026

    Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style

    FDA Enforcement
    Class II ·Ongoing·Healthmark Industries Co., Inc.·May 6, 2026

    BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·May 6, 2026