BEUDAMED
    13 results · 19ms · 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.
    Filters Regulation: Us FDA ×

    Q. FREEZE (MOTION VUE2)

    FDA 510(k)
    FDA Class 2 ·Radiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517574213·CoRoent Ant TLIF Ti, 11x13x40mm 8°

    Arx

    FDA UDI
    Life Spine, Inc.·00190837035389·ARX Depth Gage

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134080·Trial, TLIF, 27L OB STR 7Deg, 8mm

    GLOBAL ADVANTAGE HUM HD 44X18

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWT·July 18, 2002

    AT HOME DRUG TEST, MODEL 9079

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    POSTERIOR LATERAL PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMPAX CV OUTBOUND (RESULTS MGMT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014

    PROSTALAC ACET CUP 42X32

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LXH·May 15, 2013

    FINESSE ULTRA BIOPSY PROBE

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code KNW·May 23, 2011

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021