BEUDAMED
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    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0600070·Tray Insert, 1.5" Blank

    BD AUTOSHIELD PEN NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015

    Ormco

    FDA UDI
    ORMCO CORPORATION·00889989026320·ARCH LING SST 17X25 PK 10

    Semi-Tubular Plate, 7-Hole

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665027105·

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037312179·SPIKED PROTECTOR Ø 41mm

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193104164·HA PEEK EVOS Curved, , 7mmx11mmx 26mm , FLAT 6 ...

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037312056·SPIKED PROTECTOR Ø 41mm

    IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP

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

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

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

    CLEARLINK PACLITAXEL SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·February 2, 2024

    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Product Description: A clear, plastic capillary blood collection tube

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

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

    FDA Pre-Market Approval
    FDA Class 2 ·ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS

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

    FDA Pre-Market Approval
    FDA Class 2 ·ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS

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

    FDA Pre-Market Approval
    FDA Class 2 ·ARCHITECT HBSAG/CONFIRMATORY

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

    FDA Pre-Market Approval
    FDA Class 2 ·ARCHITECT HBSAG/CONFIRMATORY

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

    FDA Pre-Market Approval
    FDA Class 2 ·ARCHITECT HBSAG/CONFIRMATORY

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

    FDA Pre-Market Approval
    FDA Class 2 ·ARCHITECT HBSAG AND HBSAG CONFIRMATORY

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

    FDA Pre-Market Approval
    FDA Class 2 ·ARCHITECT HBSAG/CONFIRMATORY