BEUDAMED
    83 results · 30ms · 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 Regulation: Us FDA ×

    Arm Monopolar hook

    FDA UDI
    DEX SURGICAL·03665772000091·The monopolar hook are reusable (40 uses) endos...

    Monopolar protection sleeve

    FDA UDI
    DEX SURGICAL·03665772000046·Monopolar protection sleeve is designed to be i...

    Arm Monopolar scissors

    FDA UDI
    DEX SURGICAL·03665772000077·The monopolar scissors are reusable (20 uses) e...

    Arm Monopolar Maryland

    FDA UDI
    DEX SURGICAL·03665772000084·The monopolar maryland are reusable (40 uses) e...

    Control Handle Left

    FDA UDI
    DEX SURGICAL·03665772000022·The DEX Device control handle for left handed i...

    Protection sleeve

    FDA UDI
    DEX SURGICAL·03665772000039·Protection sleeve 2090-MDS is designed to be pl...

    Arm Needle holder

    FDA UDI
    DEX SURGICAL·03665772000060·The arm needle holder is a reusable (40 uses) e...

    Control Unit

    FDA UDI
    DEX SURGICAL·03665772000008·The console or control unit contains the DEX De...

    Sleeve applicator tool

    FDA UDI
    DEX SURGICAL·03665772000053·The Sleeve applicator tool purpose is to help t...

    Control handle

    FDA UDI
    DEX SURGICAL·03665772000015·The DEX Device control handle is comprised of a...

    Pro-Dex Surgical Driver

    FDA UDI
    PRO-DEX, INC.·00856482008207·

    Pro-Dex Surgical Driver Medicon

    FDA UDI
    PRO-DEX, INC.·00856482008245·

    Pro-Dex Surgical Driver AO Collet

    FDA UDI
    PRO-DEX, INC.·00856482008214·

    Pro-Dex Surgical Driver Custom Collet

    FDA UDI
    PRO-DEX, INC.·00856482008290·

    NON-SURGICAL LEVEL 3 ISOLATION GOWNS

    FDA Adverse Event
    Injury ·Product code OEA·November 1, 2021

    PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.

    FDA Enforcement
    Class II ·Terminated·Pro-Dex Inc·August 28, 2019

    Pro-Dex CMF Surgical Driver (AXS™ NEURO DRIVER)

    FDA UDI
    PRO-DEX, INC.·00856482008252·

    INTERA 3000

    FDA Adverse Event
    Injury ·INTERA ONCOLOGY, INC·Product code LKK·November 5, 2025

    PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.

    FDA Recall
    Terminated ·Pro-Dex Inc·Product code GEY·September 25, 2018

    DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27

    FDA Recall
    Open, Classified ·Katalyst Surgical, LLC·Product code HNR·March 25, 2026