BEUDAMED
    13 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02

    FDA Enforcement
    Class II ·Ongoing·AVID Medical, Inc.·November 20, 2024

    XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.

    FDA Enforcement
    Class II ·Ongoing·Allergan PLC·December 11, 2019

    NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

    FDA Enforcement
    Class II ·Ongoing·Nexstim PLC·June 14, 2017

    Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

    FDA Enforcement
    Class II ·Ongoing·Nexstim PLC·June 14, 2017

    McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool used to aid the intubation of the trachea. As a rigid laryngoscope it holds and shapes the anatomy allowing a clear view of the larynx and entrance to the trachea.

    FDA Enforcement
    Class II ·Ongoing·Medtronic, PLC·March 11, 2020

    Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Rocket Medical Plc·December 24, 2025

    Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Rocket Medical Plc·December 24, 2025

    Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Rocket Medical Plc·December 24, 2025

    Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Rocket Medical Plc·December 24, 2025

    Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Rocket Medical Plc·December 24, 2025

    Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices.

    FDA Enforcement
    Class II ·Ongoing·Rocket Medical Plc·December 24, 2025

    GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare GmbH·December 24, 2025

    Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SECTION CDS e. MAJOR ORTHO CDS-LF f. C-SECTION CDS g. C-SECTION CDS h. C-SECTION PROCEDURE i. C-SECTION CDS-LF j. C-SECTION CDS k. C-SECTION CDS l. C-SECTION m. C-SECTION CDS n. C-SECTION PACK-LF o. C-SECTION PACK-LF p. C-SECTION PACK-LF q. C-SECTION PACK-LF r. C-BIRTH PACK-LF s. C SECTION PACK-LF t. C-SECTION PACK-LF u. C SECTION PACK-LF v. C-SECTION PACK-LF w. C SECTION PACK-LF x. C-SECTION PACK-LF y. C-SECTION PACK z. C-SECTION PACK-LF aa. C-SECTION PACK-LF bb. C-SECTION PACK-LF cc. C-SECTION PACK-LF dd. C-BIRTH SETUP PACK-LF ee. C-SECTION PACK-LF ff. C-SECTION PACK-LF gg. C-SECTION PACK-LF hh. C SECTION PACK-LF ii. C-SECTION PACK-LF jj. C-SECTION TRAY kk. C-SECTION PACK ll. C-SECTION PACK-LF mm. C-SECTION PACK nn. C-SECTION PACK oo. C-SECTION pp. C-SECTION PACK qq. SVMMC C-SECTION PACK rr. C-SECTION PACK-LF ss. C-SECTION SETUP PACK tt. C-SECTION PACK uu. C-SECTION PACK vv. C-SECTION PACK *STANDARD* ww. C-SECTION PACK xx. C-SECTION PACK yy. C-SECTION PACK zz. C-SECTION 83305, MERCY REG aaa. CUH C-SECTION PACK-LF bbb. C-SECTION PACK-LF ccc. C-SECTION PACK ddd. C-SECTION PACK eee. C-SECTION PACK fff. C-SECTION PK ggg. C-SECTION hhh. C-SECTION PACK iii. ST JO WEST C-SECTION BASIN-LF jjj. C SECTION PACK kkk. C-SECTION PACK lll. C SECTION PACK mmm. C SECTION DELIVERY nnn. C-SECTION PACK ooo. C-SECTION PACK ppp. C SECTION qqq. WR C SECTION PACK-LF rrr. C-SECTION PACK sss. PK, L&D-C SECTION ttt. C-SECTION PACK HIGHLAND-LF uuu. C- SECTION vvv. C SECTION PACK-LF www. C-SECTION PACK xxx. C-SECTION PACK yyy. C SECTION PACK zzz. PK, L&D-C SECTION aaaa. C SECTION PACK bbbb. C SECTION PACK cccc. C-SECTION PACK dddd. SECTION PACK (CSSJE)642-LF eeee. C-SECTION PACK ffff. C-SECTION PACK-RFD gggg. C-SECTION DELIVERY PACK-LF hhhh. C-SECTION PACK iiii. C SECTION PACK jjjj. C-SECTION PACK kkkk. C SECTION llll. C SECTION PLUS PACK mmmm. C SECTION PACK-6220 nnnn. C-SECTION PACK oooo. C-SECTION PACK pppp. C-SECTION PACK - WCH qqqq. C SECTION WITH BASIN PACK rrrr. PHP C-SECTION PACK-LF ssss. C-SECTION KIT tttt. C SECTION PACK uuuu. C-SECTION vvvv. C-SECTION I PACK-LF wwww. C-SECTION PACK 2 xxxx. C-SECTION PACK-LF yyyy. C-SECTION PACK zzzz. C-SECTION PACK aaaaa. C SECTION PACK bbbbb. C-SECTION PACK ccccc. C SECTION ddddd. C SECTION PACK-LF eeeee. C SECTION PACK-LF fffff. BSMI CSECTION BIRTHING PACK ggggg. C-SECTION PACK hhhhh. C SECTION PACK-LF iiiii. C-SECTION PACK jjjjj. C SECTION PACK kkkkk. C SECTION lllll. PK, L&D-C SECTION mmmmm. C-SECTION PACK nnnnn. C SECTION ooooo. C-SECTION PACK ppppp. C-SECTION SMMC qqqqq. C SECTION PACK rrrrr. C SECTION PACK sssss. C-SECTION PACK ttttt. C SECTION #2 SHARED uuuuu. C SECTION #3 SHARED vvvvv. C SECTION wwwww. C-SECTION PACK xxxxx. CESAREAN BIRTH PACK yyyyy. C SECTION PACK-LF zzzzz. C-SECTION PACK aaaaaa. C-SECTION PACK-LF bbbbbb. C SECTION PACK cccccc. C-SECTION PACK dddddd. C-SECTION eeeeee. C-SECTION ffffff. C SECTION gggggg. C-SECTION hhhhhh. C SECTION iiiiii. C-SECTION jjjjjj. C-SECTION kkkkkk. PROHEALTH C-SECTION llllll. C SECTION mmmmmm. C SECTION nnnnnn. C-SECTION oooooo. C-SECTION pppppp. C-SECTION PACK qqqqqq. C SECTION rrrrrr. C SECTION ssssss. C-SECTION tttttt. C SECTION uuuuuu. C-SECTION - SMH vvvvvv. C-SECTION MRMC wwwwww. SCHED C SECTION xxxxxx. C-SECTION yyyyyy. C-SECTION -LF zzzzzz. ADVENTIST C-SECTION PACK aaaaaaa. C-SECTION PK-LF bbbbbbb. C-SECTION PROCEDURE ccccccc. C-SECTION II-LF ddddddd. C-SECTION I-LF eeeeeee. C-SECTION PACK fffffff. C-BIRTH PACK-LF ggggggg. C-SECTION PACK hhhhhhh. THEDACARE C-SECTION iiiiiii. C-SECTION BASIN PACK jjjjjjj. C-SECTION PACK kkkkkkk. C-SECTION PACK-LF lllllll. PPH C-SECTION PACK-LF mmmmmmm. C SECTION PACK-LF nnnnnnn. C-SECTION PACK ooooooo. C-SECTION PACK-LF

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023