BEUDAMED
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    NEOPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Kirschner wire

    FDA UDI
    ADLER ORTHO SPA·08054752863408·TIPLESS KIRSHNER WIRE D2mm L=150mm

    CapnoTrak

    FDA UDI
    Respironics Novametrix, LLC·00884838040021·CapnoTrak CO2 Nasal Cannula

    Dornier MedTech

    FDA UDI
    Dornier MedTech GmbH·04049957004231·Genesis Urology Imaging System, Left, FPD, 65 K...

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134100·Trial, TLIF, 27L OB STR 7Deg, 10mm

    AT HOME DRUG TEST, MODEL 9064

    FDA 510(k)
    FDA Unclassified ·Unknown

    CONCENTRIC RETRIEVER, MODEL 90030

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code LOX·December 16, 2022

    TREK¿

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code LOX·May 27, 2025

    AMISTEM H FEMORAL STEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 11, 2012

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 9, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 19, 2014

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    FDA Adverse Event
    Malfunction ·PENUMBRA INC.·Product code NRY·May 17, 2011

    TREK¿

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code LOX·January 7, 2026

    Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·February 19, 2014

    VERSACUT

    FDA Adverse Event
    Injury ·LUMENIS LTD·Product code GCJ·April 2, 2026

    FEM. MODULAR HEAD - M Ø32MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A·Product code LZO·April 13, 2023

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016