BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    E-CUBE 15 Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    HHM

    FDA UDI
    Oticon A/S·05707131280503·H160V2, BTE 13 WL 85 STG HHM

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100202·NEVYAS DRAPE SPECULUM OPEN WIRE

    HNM MEDICAL

    FDA UDI
    HNM STAINLESS, LLC.·00842962162026·LEEP COATED GRAVES SPECULUM, W/DSE EVACUATION S...

    TORNIER INSITE FT SUTURE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KAI SPOT MODEL KMS 200

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 12, 2025

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code LJT·January 7, 2016

    FIBERED IDC OCCLUSION SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code KRD·June 6, 2013

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008

    DEPUY PINNACLE SECTOR II

    FDA Adverse Event
    Injury ·DEPUY ORTHO·Product code KWA·June 30, 2011

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    FDA Adverse Event
    Malfunction ·COOK VASCULAR INC·Product code LJT·January 3, 2019

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    FDA Adverse Event
    Malfunction ·COOK VASCULAR INC·Product code LJT·January 3, 2019

    ARTOURA BREAST TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·August 21, 2023

    VITAL-PORT

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code LJT·May 24, 2016

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015