BEUDAMED
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    FETAL DOPPLER FOR ULTRAMARK 4 AND 8

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

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011881329220·dentaform® Snap, tooth 36, size 29/Roth 22

    LinkSymphoKnee - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575314560·Orthopaedic prosthesis implantation instrument,...

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011881329180·dentaform® Snap Band, tooth 36,size 29/Roth 18

    EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay

    FDA 510(k)
    FDA Class 2 ·Immunology

    REPROCESSED ELECTROPHYSIOLOGY CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROGRASP FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 18, 2014

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·October 7, 2010

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·December 20, 2012

    12/14 ARTICUL 40MM M SPEC+8.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 29, 2013

    PINNACLE MTL INS NEUT40IDX60OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 29, 2013

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025