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

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    OptosAdvance 4.0 Software

    FDA 510(k)
    FDA Class 2 ·Radiology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776115975·Slotted U Bracket

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·00842331120947·Slotted "U" Bracket, 5mm, 1.5"

    Avalign

    FDA UDI
    Avalign Technologies, Inc.·00190776020767·Slotted U Bracket

    K162309

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code PGW·November 14, 2019

    KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B

    FDA 510(k)
    FDA Class 2 ·Dental

    BIOPSY DIGIT-AM

    FDA 510(k)
    FDA Class 2 ·Radiology

    WAVEWRITER ALPHA PRIME

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 3, 2021

    MAGNETOM Verio Dot Upgrade. Model Number: 10684334.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 10, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 6, 2013

    UNKNOWN ZIMMER KNEE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·July 12, 2011

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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