BEUDAMED
    20 results · 19ms · Sources: EU EUDAMED, US FDA

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    DYNA-LOK CLASSIC SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAPSTONE CONTROL™ Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169109605·SPACER 4001532 6 DEG 15X32

    BioCoat

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783000870·BioCoat Pit/Fissure Bulk 5Pk (20)

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001532·artVeneer life upper anteriors, BL, BL1

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092135099·GCL Straumann Bone Level NC Engaging Verificati...

    Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping press

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159000092·Scanlan® VASCU-STATT® II single-use bulldog cla...

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092135389·GCL Straumann Bone Level NC Engaging Verificati...

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092135396·GCL Straumann Bone Level NC Engaging Verificati...

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092135402·GCL Straumann Bone Level NC Engaging Verificati...

    INTRABEAM® Surface Applicator Set 3.0 cm

    FDA UDI
    Carl Zeiss Meditec AG·04049539101464·

    JEL 15

    FDA 510(k)
    FDA Class 2 ·Dental

    RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 5, 2013

    TM RESERVE SHOULDER GLENOSPHERE HELMET

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code LXH·January 26, 2011

    INDURA

    FDA Adverse Event
    Injury ·MEDTRONIC VASCULAR·Product code LKK·February 21, 2008

    T:slim Insulin Delivery System Insulin Infusion Pump

    FDA Enforcement
    Class I ·Terminated·Tandem Diabetes Care Inc·February 19, 2014

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    FDA Enforcement
    Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024