BEUDAMED
    27 results · 26ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Enforcement ×

    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

    SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

    FDA Enforcement
    Class II ·Ongoing·Philips North America, LLC·May 22, 2019

    SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

    FDA Enforcement
    Class II ·Ongoing·Philips North America, LLC·May 22, 2019

    SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

    FDA Enforcement
    Class II ·Ongoing·Philips North America, LLC·May 22, 2019

    SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

    FDA Enforcement
    Class II ·Ongoing·Philips North America, LLC·May 22, 2019

    SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

    FDA Enforcement
    Class II ·Ongoing·Philips North America, LLC·May 22, 2019

    SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

    FDA Enforcement
    Class II ·Ongoing·Philips North America, LLC·May 22, 2019

    SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

    FDA Enforcement
    Class II ·Ongoing·Philips North America, LLC·May 22, 2019

    Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

    FDA Enforcement
    Class I ·Terminated·Richard-Allan Scientific Company·October 15, 2014

    Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99-0233-10).

    FDA Enforcement
    Class II ·Terminated·Suntech Medical, Inc.·January 22, 2020

    Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46

    FDA Enforcement
    Class II ·Terminated·Galt Medical Corporation·August 8, 2018

    Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers

    FDA Enforcement
    Class II ·Completed·Sysmex America, Inc.·November 1, 2017

    Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Usage: The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·February 20, 2013

    SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

    FDA Enforcement
    Class II ·Ongoing·Philips North America, LLC·May 22, 2019

    Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers

    FDA Enforcement
    Class II ·Terminated·Sysmex America Inc·September 21, 2016

    Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

    FDA Enforcement
    Class I ·Terminated·Richard-Allan Scientific Company·October 15, 2014

    Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

    FDA Enforcement
    Class I ·Terminated·Richard-Allan Scientific Company·October 15, 2014

    Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

    FDA Enforcement
    Class I ·Terminated·Richard-Allan Scientific Company·October 15, 2014

    Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

    FDA Enforcement
    Class I ·Terminated·Richard-Allan Scientific Company·October 15, 2014

    Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

    FDA Enforcement
    Class I ·Terminated·Richard-Allan Scientific Company·October 15, 2014