BEUDAMED
    477 results · 110ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    REVOLUTION EXTERNAL PLATING SYSTEM

    FDA Adverse Event
    Malfunction ·NEW STANDARD DEVICE INC.·Product code KTT·December 23, 2021

    REVOLUTION EXTERNAL PLATING SYSTEM

    FDA Adverse Event
    Malfunction ·NEW STANDARD DEVICE INC.·Product code KTT·December 23, 2021

    REVOLUTION EXTERNAL PLATING SYSTEM

    FDA Adverse Event
    Malfunction ·NEW STANDARD DEVICE INC.·Product code KTT·December 10, 2021

    REVOLUTION EXTERNAL PLATING SYSTEM

    FDA Adverse Event
    Malfunction ·NEW STANDARD DEVICE INC.·Product code KTT·February 18, 2022

    1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System

    FDA Recall
    Completed ·New Standard Device Inc·Product code KTT·June 8, 2020

    Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080

    FDA Recall
    Open, Classified ·New Standard Device Inc·Product code KTT·December 28, 2020

    'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

    FDA Recall
    Open, Classified ·New Standard Device Inc·Product code KTT·July 23, 2019

    Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A

    FDA Recall
    Open, Classified ·New Standard Device Inc·Product code HXC·August 14, 2019

    Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080

    FDA Enforcement
    Class II ·Ongoing·New Standard Device Inc·September 7, 2022

    1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System

    FDA Enforcement
    Class II ·Completed·New Standard Device Inc·June 15, 2022

    Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A

    FDA Enforcement
    Class II ·Ongoing·New Standard Device Inc·June 29, 2022

    'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

    FDA Enforcement
    Class II ·Ongoing·New Standard Device Inc·June 21, 2023

    RUBY COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code KRD·July 1, 2021

    OSCOR

    FDA Adverse Event
    Other ·OSYPKA MEDICAL GMBH·Product code DTE·December 23, 2013

    HS AMICA

    FDA Adverse Event
    Malfunction ·H.S. HOSPITAL SERVICE SPA·Product code GEI·February 3, 2020

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·August 29, 2013

    ECLIPSE 5

    FDA Adverse Event
    Malfunction ·CAIRE INC.·Product code CAW·June 4, 2020

    Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control procedures. The Alere Triage¿ Drug Screen Controls, when used in accordance with the test procedures described in the Alere Triage¿ TOX Drug Screen package insert, provide this capability. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Alere Triage¿ TOX Drug Screen Control 1 or Alere Triage¿ TOX Drug Screen Control 2 consist of human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. 510(k)/IDE/PMA number: K060788 Type of Packaging: 5 vials per level in a labeled kit box. Indications for use: The Alere Triage¿ TOX Drug Screen Controls are to be used with the Alere Triage¿ TOX Drug Screen tests and Alere Triage¿ Meters to assist the laboratory in monitoring test performance.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·October 30, 2013

    ECLIPSE 5

    FDA Adverse Event
    Malfunction ·CAIRE INC.·Product code CAW·May 28, 2020

    ECLIPSE 5

    FDA Adverse Event
    Malfunction ·CAIRE INC.·Product code CAW·June 4, 2020