BEUDAMED
    9 results · 19ms · 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.
    Filters Regulation: Us FDA ×

    GAUZE SPONGE; DRAIN SPONGE

    FDA 510(k)
    FDA Unclassified ·Unknown

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515244757·Inner-Flow Suct Fcps, str, str shft, 3.5mm,#0

    LUKENS STAINLESS STEEL SURGICAL SUTURE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    LENSAR LASER SYS -FS 3D

    FDA Adverse Event
    Other ·LENSAR INC·Product code OOE·June 16, 2014

    VOYAGER RX CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-CLONMEL·Product code LOX·December 22, 2010

    RENAISSANCE 26 OBS 10/25/04

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·January 30, 2013

    SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015