BEUDAMED
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    ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06945664814126·Reusable SpO2 Sensor/DRE/Finger Clip/Pediatric/...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450169087·

    mahe medical GmbH

    FDA UDI
    mahe medical gmbh·04050659256828·TI DPL-Plate 3.5mm,str.,10 H.,137mm, _x000D_...

    TI DPL-Plate 3.5mm,str.,10 H.,137mm, locking plate,colour: blue

    FDA UDI
    mahe medical gmbh·EMAH10001101370·TI DPL-Plate 3.5mm,str.,10 H.,137mm, lockin...

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·February 4, 2022

    SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORBITER II CCI/SPECT ORBITER II CCI/SPECT

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 20, 2022

    PALAXPRESS, CLEAR, 1000G POWDER

    FDA Adverse Event
    Injury ·HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION·Product code EBI·February 1, 2012

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·May 13, 2013

    ANIMAS VIBE

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

    AFFINITY 3

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code HDD·May 19, 2011

    PEDIASAT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DRE·December 10, 2025

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXG·January 7, 2025

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DQE·March 27, 2025

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXG·January 7, 2025

    Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·November 30, 2016

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·January 24, 2024