BEUDAMED
    73 results · 17ms · Sources: EU EUDAMED, US FDA

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    Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.

    FDA Enforcement
    Class II ·Ongoing·DJO, LLC·July 24, 2019

    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

    Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D; 2) CARDIAC STERNAL PACK, Model Number: DYNJ32436A; 3) VEIN CLOSURE PACK, Model Number: DYNJ35586G; 4) ABLATION PACK-LF, Model Number: DYNJ55343B; 5) ABLATION PACK-LF, Model Number: DYNJ55343B; 6) CARDIAC PACK, Model Number: DYNJ65027B; 7) VASCULAR PACK-LF, Model Number: DYNJ48196C; 8) IMPLANT PACK, Model Number: DYNJ40480; 9) OPEN HEART, Model Number: DYNJ900523B; 10) PACEMAKER PACK-LF, Model Number: DYNJ19758I; 11) CHOG VP SHUNT PACK, Model Number: SYNJ10280C; 12) VASCULAR PACK-LF, Model Number: DYNJ48196C; 13) EP PACK-LF, Model Number: DYNJ27949F; 14) PACEMAKER PACK WRO-LF, Model Number: DYNJ41874C; 15) CARDIAC PACK OPTION 1, Model Number: DYNJ83208A; 16) EP DRAPE PACK, Model Number: DYNJ56729; 17) CSTM EP PACEMAKER DRAPE PACK, Model Number: DYNJCD0326; 18) MINOR INTERVENTIONAL TRAY, Model Number: DYNJ80084; 19) CT PACK, Model Number: DYNJ39111A; 20) VASCULAR PACK-LF, Model Number: DYNJ25102I; 21) VASCULAR ACCESS PROCEDURE PACK, Model Number: DYNJ62339; 22) ANGIO TRAY, Model Number: DYNJ43278C; 23) PACEMAKER PACK-LF, Model Number: DYNJ19758I; 24) E.P. BASIC PACK-LF, Model Number: DYNJ24735F; 25) PORT A CATH PACEMAKER BJC-LF, Model Number: DYNJ41683B; 26) PACEMAKER PACK, Model Number: DYNJ39379C; 27) VEIN PACK, Model Number: DYNJ64016B; 28) EP PACK, Model Number: DYNJ68019A; 29) ENDOVENOUS BASIC PACK, Model Number: DYNJ69108A; 30) PACEMAKER PACK-LF, Model Number: DYNJHTCLP101A; 31) EP PACK, Model Number: DYNJ38147C; 32) HEART PRCMNT CHOICE, Model Number: DYNDA1841; 33) PACEMAKER PACK SMGH-LF, Model Number: DYNJ41925I; 34) EP PACK, Model Number: DYNJ81951B; 35) HEALTH ALL VASCULAR PACK-LF, Model Number: DYNJ19538F; 36) OPEN HEART, Model Number: CDS982026V; 37) OPEN HEART, Model Number: CDS982026V

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 23, 2025

    Radiography 7300 C; Model Number: 712037;

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025

    DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    EasyDiagnost Eleva DRF (Stitching Patient Support) 706032

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost Single Detector (Stitching Patient Support) 712020

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    CombiDiagnost R90 (Stitching Patient Support) 709030

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost Dual Detector (Stitching Patient Support) 712022

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost Release 3 (Stitching Patient Support) 712025

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018