BEUDAMED
    17 results · 20ms · Sources: EU EUDAMED, US FDA

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    Avanti Distal Radius and Forearm System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NOVO Surgical

    FDA UDI
    NOVO SURGICAL, INC.·00842331184185·McPherson Iris Bipolar Forceps, 0.25 mm tip, 3-...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776392338·Graves Imporoved Vaginal Specula, large, 4 1/4"...

    LinkBio Instrument

    FDA UDI
    Link Bio Corp·00810022402979·Guide Rod, Tibial Cone D18/L80

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973107590·TRIAL 90-SRK-191118 POLY-MPCS 1X18 RIGHT

    FOOT AND HAND MOTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACTIVON TULLE

    FDA 510(k)
    FDA Unclassified ·Unknown

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·March 28, 2002

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·March 12, 2002

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·August 27, 2015

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    FDA Adverse Event
    Injury ·SORIN GROUP CANADA INC.·Product code DYE·October 21, 2014

    NX3 CEMENT

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·June 26, 2013

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·July 19, 2011

    ALINITY C PROCESSING MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT GERMANY·Product code JJE·September 19, 2019

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·July 27, 2023

    Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016