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

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    CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAKOPLASTY

    FDA UDI
    MAKO SURGICAL CORP.·00848486018368·HIP ARRAY KIT PULL OUT TRAY

    HHM

    FDA UDI
    Oticon A/S·05707131286109·H160V2 TI, RITE 312 WL SIL HHM

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690199533·Modular Knee Straight Reamer - 23mm

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690122753·Modular Stem 23mm x 150mm

    MAYO GALLSTONE SCOOP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896076594·MAYO GALLSTONE SCOOP

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 31, 2023

    FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    IQ 200 URINE ANALYZER BODY FLUIDS MODULE

    FDA 510(k)
    FDA Class 2 ·Hematology

    3.5MM TI TRANSVERSE BAR

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code KWP·February 19, 2013

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·March 21, 2018

    RADIFOCUS OPTITORQUE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 6, 2013

    SM104 MSERIES W5TH WHL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·June 10, 2011

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORP·Product code LGW·September 3, 2008

    OPTITORQUE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Malfunction ·Product code DQO·January 20, 2021

    da Vinci Si Surgical System 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 S / Si Surgical System IS2000 / IS3000, Instrument 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