BEUDAMED
    42 results · 9ms · Sources: EU EUDAMED, US FDA

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

    Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS/IntelliSpace PACS DCX is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS / IntelliSpace PACS DCX receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Typical users of the MDC PACS /IntelliSpace PACS DCX and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians. technologist and others

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems, Inc.·April 30, 2014

    DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.

    FDA Enforcement
    Class II ·Terminated·Musculoskeletal Transplant Foundation, Inc.·April 29, 2015

    DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100

    FDA Enforcement
    Class II ·Ongoing·Musculoskeletal Transplant Foundation, Inc.·November 29, 2023

    AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . The AVS¿ ARIA TM PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

    FDA Enforcement
    Class II ·Terminated·Stryker Spine·October 17, 2018

    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

    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

    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

    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

    SOZO Bilateral Arm L-Dex Software

    FDA Enforcement
    Class II ·Ongoing·Impedimed Limited·November 1, 2023

    VIDAS DEX@, Dimer Exclusion II, REF 30455-01

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    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

    KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000

    FDA Enforcement
    Class II ·Ongoing·Pro-Dex Inc·November 6, 2024