BEUDAMED
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    ORIHEALTH MEDICAL PRODUCTS(SUZHOU)CO.,LTD

    FDA registration
    ORIHEALTH MEDICAL PRODUCTS(SUZHOU)CO.,LTD·3 products·🇨🇳 China

    Veris Health

    FDA UDI
    Veris Health Inc.·00860009591004·Medical Device Data Systems (MDDS)

    DIATRUSTTM COVID-19 AG HOME TEST

    FDA Adverse Event
    Malfunction ·HUMASIS CO., LTD.·Product code QKP·September 28, 2022

    PS TIBIAL INSERTS SZ 2, 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 21, 2023

    COVID ANTIGEN RAPID TEST KIT (SEALED SWAB IN BOX)

    FDA Adverse Event
    Injury ·IHEALTH LABS, INC.·Product code QKP·September 29, 2023

    COVID ANTIGEN RAPID TEST KIT (SEALED SWAB IN BOX)

    FDA Adverse Event
    Injury ·IHEALTH LABS, INC.·Product code QKP·September 29, 2023

    COVID ANTIGEN RAPID TEST KIT (SEALED SWAB IN BOX)

    FDA Adverse Event
    Injury ·IHEALTH LABS, INC.·Product code QKP·September 29, 2023

    CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000 CORI Starter Kit (2) ROB10024 Real Intelligence CORI (3) ROB10197 CORI STARTER KIT - UNIVERSAL Note: the three product numbers cover the three different configurations in which the CORI Console is sold

    FDA Recall
    Open, Classified ·Blue Belt Technologies, Inc·Product code OLO·May 7, 2024

    IHEALTH COVID-19 TEST

    FDA Adverse Event
    Malfunction ·IHEALTH LABS, INC. /IHEALTH MANUFACTURING INC.·Product code QKP·January 17, 2023

    IHEALTH

    FDA Adverse Event
    Malfunction ·ANDON MEDICAL CO.,LTD·Product code QKP·July 4, 2022

    Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-Stat Analyzer, but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures.

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

    Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

    FDA Recall
    Open, Classified ·Blue Belt Technologies, Inc·Product code OLO·September 7, 2023

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 3, 2023

    LOGIC TIBIA PS MOD INSRT SZ 3 13MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 19, 2024

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 30, 2023

    LOGIC FEMORAL PS CEM LEFT SZ 3

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 21, 2024

    KNEE IMPLANT - PATELLAR COMPONENT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 21, 2024

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 25, 2023

    IHEALTH

    FDA Adverse Event
    Malfunction ·ANDON MEDICAL CO.,LTD·Product code QKP·October 24, 2022