BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

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    MADM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HHM

    FDA UDI
    Oticon A/S·05707131269096·H110, DESIGNRITE 10 WL DBL HHM

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694016612·MFx 125 Degree Contoured Reconstruction Plate, ...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694064866·2.4 System 5 x 16 Hole Reconstruction Left Plat...

    T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060

    FDA 510(k)
    FDA Class 2 ·Radiology

    CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 9, 2023

    CELL-DYN 1700

    FDA Adverse Event
    Injury ·CELLDYN·Product code JJE·August 29, 2006

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 31, 2013

    ENDO GIA ROTICULATOR 60-3.5 SULU

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GDW·June 15, 2011

    DEXTRUS 4135

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code DTB·August 29, 2008

    PKG, BLAKESLY BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080293. 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

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024