BEUDAMED
    13 results · 30ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    Idylla Respiratory (IFV-RSV) Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111300509·TC STELLA SCISS SERR S-CUP 7"

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A163628120·16mm H x 36mm W x 28mm L x 12 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A163628150·16mm H x 36mm W x 28mm L x 15 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A16362880·16mm H x 36mm W x 28mm L x 8 degrees ALIF

    AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY

    FDA 510(k)
    FDA Class 2 ·Radiology

    INDIGO SYSTEM ASPIRATION CATHETER

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code DXE·August 11, 2020

    BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·December 4, 2023

    VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HRS·June 11, 2013

    BIOTENE ORALBALANCE GEL

    FDA Adverse Event
    Other ·GLAXOSMITHKLINE·Product code KOO·June 10, 2011

    QUICKSTRAP ENDOTRACHEAL TUBE HOLDER

    FDA Adverse Event
    Malfunction ·SMITH MEDICAL, ASD.·Product code CBH·September 9, 2008

    Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTEL RT-EMB; A4405, 4F-80CM, SYNTEL RT-EMB; A4406, 5F-80CM, SYNTEL RT-EMB; A4407, 6F-80CM, SYNTEL RT-EMB; A4408, 7F-80CM, SYNTEL RT-EMB; A4F00, 2F-60CM (PREM) SYNTEL CATHETER; A4F01, 2F-80CM, (PREM) SYNTEL CATHETER; A4F02, 3F-40CM, (PREM) SYNTEL CATHETER; A4F03, 3F-80CM, (PREM) SYNTEL CATHETER; A4F04, 4F-40CM, (PREM) SYNTEL CATHETER; A4F05, 4F-80CM, (PREM) SYNTEL CATHETER; A4F06, 5F-80CM, (PREM) SYNTEL CATHETER; A4F07, 6F-80CM, (PREM) SYNTEL CATHETER; A4F08, 7F-80CM, (PREM) SYNTEL CATHETER; CE0260ST, L2F-60CM PREM SYNTEL CATH; CE0280ST, L2F-80CM PREM SYNTEL CATH; CE0340ST, 3F-40cm (PREM) SYNTEL CATHETER; CE0380ST, 3F-80CM PREM SYNTEL CATH; CE0440ST, 4F-40CM PREM SYNTEL CATH; CE0480ST, 4F-80CM PREM SYNTEL CATH; CE0580ST, 5F-80CM PREM SYNTEL CATH; CE0680ST, 6F-80cm (PREM) SYNTEL CATHETER; CE0780ST, 7F-80CM PREM SYNTEL CATH; CE0340, 3F-40cm, SYNTEL RT-EMB; CE0380, 3F-80cm, SYNTEL RT-EMB; CE0440, 4F-40cm, SYNTEL RT-EMB; CE0480, 4F-80cm, SYNTEL RT-EMB; CE0580, 5F-80cm, SYNTEL RT-EMB; CE0680, 6F-80cm, SYNTEL RT-EMB; CE0780, 7F-80cm SYNTEL RT-EMB. BARD Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system. These devices consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·October 3, 2012