BEUDAMED
    21 results · 23ms · 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 ×

    STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES

    FDA 510(k)
    FDA Class 2 ·Neurology

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00311011·

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00311161·

    3M™ Unitek™ APC™ Clarity™ MBT™

    FDA UDI
    3M UNITEK CORPORATION·00652221287465·APC FF Clarity Ultra SL MBT U/L Lt/Rt 5X5 Hk 022

    Diamondback Peripheral

    FDA UDI
    Cardiovascular Systems, Inc.·10850000491028·Diamondback Peripheral, Exchangeable Series, Ca...

    SYNTHES (USA) ORIBITAL MESH PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PANORET, MODEL 1000A

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·April 24, 2018

    PRECISION THIN SAGITTAL BLADE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY·Product code GFA·May 20, 2019

    UNIVERSAL HEXLOC SHELL 52MM B

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·March 22, 2012

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·March 14, 2013

    COLLEAGUE CXE1 PUMP UNREFURB

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - BUFFALO GROVE·Product code FRN·February 28, 2011

    IMPLANTIUM

    FDA Adverse Event
    Other ·DENTIUM·Product code DZE·February 22, 2008

    28ID SZB HEX LINER 10DEG - ARCOM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·March 22, 2012

    OXFORD BEARING

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·May 10, 2017

    OXFORD TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·May 10, 2017

    IV SET AN120 W/O BP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·September 11, 2020

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 2025

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    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