BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    SonoAir Series Digital Color Doppler Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Syntec-Taichung Bone Plates and Screws

    FDA UDI
    SYNTEC SCIENTIFIC CORPORATION·04719875418945·Limited Contact Compression Plate(Narrow)3.5 x ...

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 4, 2024

    Mya Joy PLUS Breast Pump

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MODIFICATION TO VERTE-STACK SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 25, 2011

    ASAHI REXEED SX/LX DIALYZERS

    FDA Adverse Event
    Injury ·ASAHI KASEI MEDICAL CO., LTD·Product code KDI·October 30, 2014

    AQUAMANTYS 6.0 BIPOLAR SEALER

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY, LLC·Product code DWG·July 12, 2013

    S-ROM M HEAD 36MM +0

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·January 10, 2012

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·January 10, 2012

    EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·June 25, 2014

    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

    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