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

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·July 5, 2023

    Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·July 5, 2023

    Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B¿2-Microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·September 2, 2015

    AC Powered hospital adjustable bed.

    FDA Enforcement
    Class II ·Terminated·Umano Medical, Inc.·June 10, 2020

    nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.

    FDA Enforcement
    Class II ·Terminated·NordicNeuroLab AS·June 6, 2018

    RAPTAR Laser Range Finders

    FDA Enforcement
    Class II ·Ongoing·Potomac River Group, Corp.·November 3, 2021

    EVIS EXERA III Bronchovideoscope

    FDA Enforcement
    Class II ·Terminated·Aizu Olympus Co., Ltd.·August 31, 2022

    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·June 20, 2018

    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·June 20, 2018

    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·June 20, 2018

    Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.

    FDA Enforcement
    Class II ·Terminated·Sheffield Pharmaceuticals, LLC·July 8, 2015

    SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·August 13, 2014

    SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·August 13, 2014

    Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227

    FDA Enforcement
    Class II ·Ongoing·Beaver Visitec International, Inc.·June 26, 2024

    B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health Inc.·May 27, 2020

    O.B. PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 2015

    O.B. PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 2015

    Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Certified Safety Manufacturing logo, and sold blank. product Usage: Provides sterile environment to protect patient from infection

    FDA Enforcement
    Class II ·Terminated·Certified Safety Mfg Inc·September 6, 2017

    EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·February 22, 2023

    O.B. PACK 4/CS REV. Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 2015