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

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    EchoS

    FDA 510(k)
    FDA Class 2 ·Radiology

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486000653·MCK Femoral Component

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776198442·Malleable Suction Tube wfinger cont

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197530149·RZ Tebbet Breast Retractor 180x16...

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973107101·TRIAL 90-SRK-180516 POLY PS 5X16MM

    GM HELIX IMPLANT 6.0X10

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 2, 2019

    LAMIN AIR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ANYPLUS PEEK CAGES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GM HELIX IMPLANT 6.0X8 MM

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 21, 2019

    GM HELIX IMPLANT 6.0X10

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 20, 2019

    TIBIAN INSERT ONLAY SZ 7

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code NPJ·April 9, 2018

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 4, 2014

    GM HELIX ACQUA IMPLANT 6.0X10

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 18, 2019

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 17, 2014

    EPOLY 36MM RINGLOC LINER MROM SZ24

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·June 20, 2013

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·July 27, 2011

    GM HELIX IMPLANT 6.0X8

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·June 17, 2019

    Stryker Ureteral Kit, Model number 220-180-516, The ureteral kit is a ureteral transillumination device with reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application. The device is intended to be used to transilluminate the ureter during laparoscopic and open surgical procedures of the lower abdomen or pelvic areas to help the surgeon identify the ureter.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code FCS·May 9, 2008

    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017