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

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    GE EchoPAC

    FDA 510(k)
    FDA Class 2 ·Radiology

    Oticon

    FDA UDI
    Oticon A/S·05707131286284·NERA2 PRO TI, MINIRITE 312 WL SGR

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690117308·Distal Reamer (Hudson)

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100028·BLUMENTHAL SPECULUM X-HEAVY

    Mariner Cortical

    FDA UDI
    Seaspine Orthopedics Corporation·10889981168018·CORTICAL SHANK, Cannulated, 5.0 X 85

    Mariner Cortical

    FDA UDI
    Seaspine Orthopedics Corporation·10889987168012·CORTICAL SHANK, Cannulated, 5.0 X 85

    Engage Partial Knee System

    FDA UDI
    Engage UNI LLC·B6951500850000·Anchor Removal Tool

    ENGAGE

    FDA UDI
    Smith & Nephew, Inc.·00885556875063·ANCHOR REMOVAL TOOL

    VANTAGE VIEW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OSTEOPAL V

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Engage Partial Knee System

    FDA UDI
    Engage UNI LLC·B695150085000A0·Anchor Removal Tool

    BD SYRINGE CONTROL 10ML LL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 27, 2024

    ALIGN TO URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code OTN·May 31, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011

    NEXGEN COMPLETE KNEE SOLUTION ALL POLY PATELLA

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code HTG·August 29, 2008

    UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KOB·May 2, 2018

    da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015