BEUDAMED
    15 results · 36ms · 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 ×

    CROSSER RECANALIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517564160·CoRoent Ant TLIF PEEK, 11x12x30mm 8°

    23mm x 10mm x 8mm PLIF with Inserter

    FDA UDI
    XENCO MEDICAL LLC·B064XM01123081·23mm x 10mm x 8mm PLIF with Inserter

    23mm x 10mm x 8mm Titanium PLIF with Inserter (Pack of 2)

    FDA UDI
    XENCO MEDICAL LLC·B064XMTL11123082·

    23mm x 10mm x 8mm Titanium PLIF with Inserter

    FDA UDI
    XENCO MEDICAL LLC·B064XMTL1112308·

    SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS

    FDA 510(k)
    FDA Class 2 ·Dental

    KAVO QUATTROCARE

    FDA 510(k)
    FDA Class 1 ·Dental

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·May 14, 2013

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 23, 2014

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·May 24, 2011

    HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026