BEUDAMED
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    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814589·GENUMEDI SAND SIZE VII

    CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NKB·May 1, 2014

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 2, 2012

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·May 25, 2016

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814701·GENUMEDI SILVER SIZE VII

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814527·GENUMEDI SAND SIZE I

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837026738·11mm x 27mm x 7mm PLATEAU Interbody, 0°, Curved...

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837051006·

    MODIFICATION TO: COMPEL SURGICAL DRAPES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING

    FDA 510(k)
    FDA Class 2 ·Radiology

    22 G X 1IN.BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 9, 2017

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 2, 2024

    RENAISSANCE 26 P-WASS 10/04

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 9, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 19, 2014

    COMPACT EXCHANGE DEVICE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - LARGO·Product code KDJ·May 25, 2011

    COBAS® SARS-COV-2 & INFLUENZA A/B

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QLT·March 28, 2022

    ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)

    FDA Enforcement
    Class II ·Ongoing·Healthmark Industries Co., Inc.·June 11, 2025

    Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1132 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·January 15, 2014

    Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·December 12, 2012