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

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    ODONTOSURGE 3

    FDA 510(k)
    FDA Class 2 ·Dental

    ZR-Cem

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783000573·ZR-Cem Shade White

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00156011·

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001560·artVeneer life lower anteriors, UIS, BL1

    Scanlan® VASCU-STATT® Plus aprox s-use bulldog clamp w/Gentle-Jaw™ surface

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159000665·Scanlan® VASCU-STATT® Plus aprox s-use bulldog ...

    VERSABOND BONE CEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNTHES (USA) RESORBABLE TACK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 10, 2013

    3.5 MM CANNULATED LOCKING SCREW 90 MM LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·March 24, 2022

    3.5 MM CANNULATED LOCKING SCREW 85 MM LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HRS·March 24, 2022

    FLOW-I C20 ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code BSZ·October 21, 2025

    Midmark Extraoral Imaging System (EOIS)

    FDA UDI
    MIDMARK CORPORATION·00841709118371·

    ACRYSOF RESTOR

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·March 11, 2013

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GCJ·January 26, 2011

    COMPACT LOW IMPEDANCE LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·February 21, 2008

    Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.

    FDA Enforcement
    Class II ·Terminated·Oxus America, Inc.·February 13, 2013

    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

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

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

    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