BEUDAMED
    144 results · 22ms · Sources: EU EUDAMED, US FDA

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    DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CENMED

    FDA UDI
    BIOCHEMICAL DIAGNOSTICS INC·00810042682962·CenMed hCG Serum Control POSITIVE, 5mL

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193110127·HA PEEK EVOS Straight, ,15mmx9mmx 22mm , BICONV...

    18M - Class A 21 - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620152·18M - Class A 21 - Metal

    Phantom® Fibula Nail System

    FDA UDI
    Paragon 28, Inc.·00889795136961·2.0mm x 150mm, Trocar K-Wire

    QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015)

    FDA 510(k)
    FDA Class 2 ·Dental

    OSTEON, OSTEON SINUS, OSTEON LIFTING

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NUROLON NYLON SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAR·October 23, 2018

    IMPELLA CP

    FDA Adverse Event
    Injury ·ABIOMED EUROPE GMBH·Product code OZD·October 19, 2017

    PFC SIGMARP STB TB IN 4 15.0

    FDA Adverse Event
    Injury ·NOV 12, 2015·Product code NJL·December 2, 2015

    CAREFUSION

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code CBK·February 12, 2015

    RETRACTABLE CANNULATED KNIFE, STRAIGHT

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code GFA·May 21, 2013

    SUPPORT ARM 177

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code IOY·September 19, 2014

    DIGITALDIAGNOST

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS DMC GMBH·Product code MQB·May 24, 2011

    K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support.

    FDA Recall
    Terminated ·Breg Inc·Product code IQI·March 14, 2014

    K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support.

    FDA Enforcement
    Class II ·Terminated·Breg Inc·April 16, 2014

    MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.

    FDA Enforcement
    Class II ·Completed·Baxter Healthcare Corp.·March 25, 2015

    AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer Kit, Sterile, Catalog number: 06597012; 3) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597013; 4) AngioDynamics 5F Standard Micro- Introducer Kit, Sterile, Catalog Number: 06597018; and 5) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597019. Product kits are individually wrapped in plastic, 10 units included per box. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.

    FDA Enforcement
    Class II ·Terminated·Angiodynamics, Inc.·June 5, 2013

    ENT Tray, Kit number AMS1195(A convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016