BEUDAMED
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    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

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

    FDA Recall
    Terminated ·Cardinal Health Inc.·Product code JIN·April 20, 2020

    AC Powered hospital adjustable bed.

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

    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

    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

    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

    "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·September 18, 2013

    ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test)

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc·November 26, 2014

    Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull tie, and a 10 French, 30 cm polyvinylchloride connecting tube with one-way stopcock.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·October 21, 2020

    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 Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code NBC·June 23, 2014

    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 Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code NBC·June 23, 2014

    i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·August 15, 2012

    Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.

    FDA Enforcement
    Class II ·Terminated·Precision Medical, Inc.·November 25, 2015

    Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·January 1, 2004