BEUDAMED
    154 results · 10ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO

    FDA Enforcement
    Class II ·Terminated·TriMed Inc.·April 18, 2018

    Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing without prescription***Consult instructions for use*** Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·September 5, 2012

    DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

    DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

    DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

    DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

    DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

    Paltop 1.25 Hex Drivers, Short Part Number: 60-70102

    FDA Enforcement
    Class II ·Terminated·Keystone Dental Inc·April 3, 2019

    Paltop 1.25 Hex Drivers, Long Part Number: 60-70101

    FDA Enforcement
    Class II ·Terminated·Keystone Dental Inc·April 3, 2019

    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

    DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

    UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·September 23, 2015

    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

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

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

    Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021

    FDA Enforcement
    Class II ·Terminated·Keystone Dental Inc·April 3, 2019

    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

    Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112

    FDA Enforcement
    Class II ·Terminated·Keystone Dental Inc·April 3, 2019