BEUDAMED
    27 results · 15ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × 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

    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

    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

    Thio Med w/Dex, Hem, Vit K (7ml) 20/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    FDA Enforcement
    Class II ·Terminated·Remel Inc·May 29, 2019

    FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip.

    FDA Enforcement
    Class II ·Terminated·Djo Surgical·March 12, 2014

    VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.

    FDA Enforcement
    Class II ·Terminated·DJO, LLC·July 10, 2013

    Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat within body tissues.

    FDA Enforcement
    Class II ·Terminated·DJO, LLC·October 21, 2015

    This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended to be used based on the devices associated with them. Nylatex wraps are composed of nylon and natural rubber and are accessories used to secure electrodes or thermal therapy to a patient.

    FDA Enforcement
    Class II ·Terminated·DJO, LLC·July 22, 2020

    Thio Med w/o Ind, w/Dex (18ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    FDA Enforcement
    Class II ·Terminated·Remel Inc·May 29, 2019

    Thio Med w/Dex, Hem, Vit, K (7ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    FDA Enforcement
    Class II ·Terminated·Remel Inc·May 29, 2019

    Thio Med w/o Ind, w/Dex (18ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    FDA Enforcement
    Class II ·Terminated·Remel Inc·May 29, 2019

    Thio Med w/Dex, Hem, Vit K (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    FDA Enforcement
    Class II ·Terminated·Remel Inc·May 29, 2019

    Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    FDA Enforcement
    Class II ·Terminated·Remel Inc·May 29, 2019

    Thio Med w/o Ind, w/Dex (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    FDA Enforcement
    Class II ·Terminated·Remel Inc·May 29, 2019

    Thio Med w/Dex, Hem, Vit K (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    FDA Enforcement
    Class II ·Terminated·Remel Inc·May 29, 2019

    Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    FDA Enforcement
    Class II ·Terminated·Remel Inc·May 29, 2019

    Thio Med w/Dex, Hem, Vit K(10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    FDA Enforcement
    Class II ·Terminated·Remel Inc·May 29, 2019

    Thio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    FDA Enforcement
    Class II ·Terminated·Remel Inc·May 29, 2019

    Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Enforcement
    Class II ·Terminated·Pro-Dex Inc·March 23, 2016

    Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Enforcement
    Class II ·Terminated·Pro-Dex Inc·March 23, 2016