BEUDAMED
    15 results · 20ms · 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 ×

    Rubicon™ Control Support Catheter (H749394323506A1)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRS CRANIAL BONE VOID FILLER(TRS C-BVF)

    FDA 510(k)
    FDA Class 2 ·Neurology

    SOVIS OPTIQUE'S ENDOSCOPIC CABLE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MICROLET®

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code QRL·April 23, 2026

    MICROLET®

    FDA Adverse Event
    Injury ·ASCENSIA DIABETES CARE US INC.·Product code QRL·April 3, 2025

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    OT VERIO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 25, 2011

    UNKNOWN

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JDI·July 12, 2013

    MICROLET®

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code QRL·July 1, 2025

    MICROLET®

    FDA Adverse Event
    Injury ·ASCENSIA DIABETES CARE US INC.·Product code QRL·December 1, 2023

    Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·July 13, 2016

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021