BEUDAMED
    21 results · 24ms · 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 ×

    SOLAR SHOULDER OFFSET HUMERAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00174191·

    Hakasui Tips

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783003734·MIX TIPS (35)

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001419·artVeneer life lower anteriors, UBXL, C4

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00514191·

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967188102·Battalion, LLIF Trial, 0°, 14 mm Wide, 19 mm X ...

    MINIMED QUICK-SET

    FDA Adverse Event
    Injury ·UNOMEDICAL UM-D·Product code FPA·December 31, 2024

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·December 2, 2009

    TI500 GLOBE-TROTTER TRANSPORT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ROVERS ENDOCERVEX-BRUSH

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

    WS TITAMAX IMPLANT 4.0X5

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·February 26, 2018

    NATURALYTE

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·March 8, 2013

    NAIL RIGID REAMER DIAMETER 7 MM LENGTH 410 MM

    FDA Adverse Event
    Other ·ORTHOFIX SRL·Product code HSB·January 26, 2011

    INTEGRA CAMINO

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES·Product code GWM·January 25, 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

    Xhibit Telemetry Receiver, Model: 96280

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    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