BEUDAMED
    23 results · 21ms · Sources: EU EUDAMED, US FDA

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    NEXUS 2 CLEAR

    FDA 510(k)
    FDA Class 2 ·Dental

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120136091·Steel - Surgical instruments

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0106090·Trial, 26 x 9mm, 8 Degree, Tapered, Straight

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132090·Trial, TLIF, 27L OB CRV 7Deg, 9mm

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033542514·

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134090·Trial, TLIF, 27L OB STR 7Deg, 9mm

    True Position®

    FDA UDI
    ATLAS SPINE, INC.·M68112080136090·36mm x 9mm Lordotic Spacer

    True Position® Spacer System

    FDA UDI
    Spine Wave, Inc.·10840642107630·Implant, Lordotic, 36 (L) x 9 (H) mm, 7°

    N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACCUSONIC, MODEL AS-260

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·March 20, 2013

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·March 10, 2011

    LINOX SD 65/16

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code LWS·March 13, 2008

    VASCURE FOR VASCULAR REPAIR

    FDA Adverse Event
    Injury ·AZIYO BIOLOGICS INC.·Product code DXZ·November 4, 2020

    CORMATRIX ECM FOR VASCULAR REPAIR

    FDA Adverse Event
    Malfunction ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·September 30, 2015

    VASCURE FOR VASCULAR REPAIR

    FDA Adverse Event
    Injury ·AZIYO BIOLOGICS, INC.·Product code DXZ·May 5, 2022

    VASCURE FOR VASCULAR REPAIR

    FDA Adverse Event
    Injury ·ELUTIA INC.·Product code DXZ·January 15, 2025

    VASCURE FOR VASCULAR REPAIR

    FDA Adverse Event
    Injury ·ELUTIA INC.·Product code DXZ·January 15, 2025

    PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080120 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

    PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 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