BEUDAMED
    113 results · 6ms · Sources: EU EUDAMED, US FDA

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

    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

    Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable) 2089610-001-S FLOW SENSOR, LEGACY VAR ORF BCG, SERVICE (blue, cleanable) 2087640-001 FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG (gray, autoclavable) 2087640-001-S FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG, SERVICE (gray, autoclavable) 2096513-001-S FLOW SENSOR ASSEMBLY 5697309 R-FMI34109-FLOW SENSOR, LEGACY VAR ORF BCG 5697310 R-FMI34109-FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·October 6, 2021

    The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur, and test results are generated for each analyte independently of the other analyte. The ALB test is a multilayered, analytical element coated on a polyester support. For the albumin measurement, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. When the fluid penetrates the reagent layer, the bromocresol green (BCG) dye diffuses to the spreading layer and binds to albumin in the sample. This binding results in a shift in wavelength of the reflectance maximum of the free dye. The color complex that forms is measured by reflectance spectrophotometry. The amount of albumin-bound dye is proportional to the concentration of albumin in the sample. Model/Catalog Number: 6844293

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·August 28, 2024

    Plum Duo Precision IV Pump, 40002-0403

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·June 17, 2026

    Plum Duo Infusion Pump, 40002-0401

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·June 17, 2026

    Plum Solo Precision IV Pump, 40001-0401

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·June 17, 2026

    Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·May 27, 2026

    ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·January 28, 2026

    Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG

    FDA Enforcement
    Class II ·Ongoing·ICU Medical Inc.·January 21, 2026

    Portex Spinal Tray, Item No. A3729-24 A3595

    FDA Enforcement
    Class II ·Ongoing·ICU Medical Inc.·January 21, 2026

    LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·December 31, 2025

    ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·January 28, 2026

    ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·January 28, 2026

    Plum Duo Infusion System, List Number 40002-04-01

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·January 21, 2026

    Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·January 28, 2026

    LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·December 31, 2025

    ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025