BEUDAMED
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    ELLIK BLADDER EVACUATOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    0800,APS1,08,N,VL,IW

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828153027·0800,APS1,08,N,VL,IW

    ACUMED

    FDA UDI
    Acumed LLC·10806378041877·2.5mm Cannulated QR Hex Driver Tip

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209103676·KIT, NAR-4 AID RESUPPLY; This kit contains item...

    SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·October 22, 2012

    UNKNOWN - UNSPECIFIED BY THE COMPLAINANT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INCORPORATED·Product code PAG·April 3, 2014

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 27, 2015

    MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-774

    FDA Enforcement
    Class II ·Ongoing·Angiodynamics, Inc.·March 27, 2024

    Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code NHJ·February 18, 2026

    3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bonding process of orthodontic appliances to teeth.

    FDA Recall
    Open, Classified ·3M Unitek Corporation·Product code KLE·November 26, 2024

    FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. (CLIA Waived Laboratories)

    FDA Recall
    Terminated ·Versea Diagnostics LLC·Product code QKO·July 27, 2021

    Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code CBK·May 29, 2024

    Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms. Emergency use of this test is limited to authorized laboratories. (CLIA Waived Laboratories)

    FDA Recall
    Terminated ·Versea Diagnostics LLC·Product code QMN·July 27, 2021

    CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. (CLIA Waived Laboratories)

    FDA Recall
    Terminated ·Versea Diagnostics LLC·Product code QKP·July 27, 2021

    Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories. Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate or high complexity tests

    FDA Recall
    Terminated ·Versea Diagnostics LLC·Product code QKO·July 27, 2021

    Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code CBK·December 20, 2024

    Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code CBK·December 20, 2024

    Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code CBK·December 20, 2024