BEUDAMED
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    Cytomegalovirus (Cmv) Dna Quantitative Assay

    FDA Pre-Market Approval
    FDA Class 2 ·Aptima CMV Quant Assay

    Cytomegalovirus (Cmv) Dna Quantitative Assay

    FDA Pre-Market Approval
    FDA Class 2 ·Aptima CMV Quant Assay

    Cytomegalovirus (Cmv) Dna Quantitative Assay

    FDA Pre-Market Approval
    FDA Class 2 ·Aptima CMV Quant Assay

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319744123·Iowa University Periosteal Elevator 7-1/4" (18....

    15° Esthetic Abutment H1mm Ti

    FDA UDI
    T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION·10810190011024·

    Standard Healing Cap 2mm

    FDA UDI
    NOGA MEDICAL PRODUCTS LTD·07290118142980·Standard Healing Cap 2mm

    XtraFix® External Fixation System

    FDA UDI
    Zimmer, Inc.·00889024081154·

    Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL

    FDA Enforcement
    Class II ·Ongoing·Covidien, LP·April 10, 2024

    BD¿ QUINCKE SPINAL NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code BSP·August 31, 2023

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·EUFLEXXA (1% SODIUM HYALURONATE)

    ALINITY I HBSAG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·March 16, 2026

    IPUMP PAIN MANAGEMENT PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code MEA·October 21, 2008

    EGIA ULTRA UNIVERSAL SHORT STAPLER

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL A·Product code GDW·August 2, 2011

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 27, 2013

    ARCHITECT HBSAG QUALITATIVE II

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·March 31, 2026

    ALINITY I HBSAG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·May 18, 2026

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·Euflexxa (1% Sodium Hyaluronate)

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·Alinity i HBsAg Qualitative II Reagent Kit (2x100 Tests), Alinity i HBsAg Qualitative II Reagent Kit (2x600 Tests), Alin

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·ARCHITECT HBsAg Qualitative/HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative/HBsAg Qualitative Confirmatory