BEUDAMED
    15 results · 24ms · Sources: EU EUDAMED, US FDA

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    Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MLKJ

    FDA UDI
    Weifang Mingliang Electronics Co., Ltd.·06974077940023·

    Tecomet

    FDA UDI
    TECOMET INC.·00841435119970·Locking Pliers

    DRY LASER IMAGER, MODEL DRYPRO MODEL 793

    FDA 510(k)
    FDA Class 2 ·Radiology

    ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    THERAPY ABLATION CATHETER

    FDA Adverse Event
    Malfunction ·IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY·Product code OAD·June 25, 2010

    GLIDEWELL HT IMPLANT Ø4.3 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 3, 2025

    GLIDEWELL HT IMPLANT Ø4.3 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 29, 2025

    GLIDEWELL HT IMPLANT Ø4.3 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·January 30, 2026

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 29, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 20, 2024

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 10, 2014

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 9, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013

    PKG, 5MM X 33CM, INSERT, FENESTRATED GRASPER, P/N 0250080755 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014