BEUDAMED
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    AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    JOBST Bella Strong

    FDA UDI
    BSN MEDICAL, INC.·00035664009748·BELLA STRONG 20-30 MM HG ARMSLEEVE KNIT WELT SI...

    ZEOS

    FDA UDI
    SANTA BARBARA IMAGING SYSTEMS, INC.·00812231030035·ZEOS HD CAMERA HEAD, C-MOUNT

    DANmed

    FDA UDI
    STERIS Deutschland GmbH·04251351101083·LAP- Electrode, monop., Ø5mm, l=330mm Hook 9...

    Viceroy

    FDA UDI
    DIOMEDICAL CO.,LTD.·08800113904873·VICEROY Rod - 5.5 (D)5.5x(L)330mm

    NAVIGUS PEEL AWAY INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Neurology

    SIMPLICITY EURO QD INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    PENUMBRA SMART COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·December 11, 2015

    LINER: CC E CC LIGHT HOODED PE HC FIXED 32 / F

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 29, 2020

    UNKNOWN DEPUY CERAMIC FEMORAL HEAD

    FDA Adverse Event
    Injury ·9616671 DEPUY (IRELAND)·Product code JDI·May 9, 2013

    ACCU-CHEK ® AVIVA COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·September 19, 2014

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·May 20, 2011

    ANGIODYNAMICS

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS INC·Product code GEI·December 11, 2007

    10) Brivo MR355/Optima MR360 Not yet 510(K) cleared and are not distributed in the US. (K103330) The Brivo MR355/ Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Brivo MR355/ Optima MR360 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

    Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·March 9, 2016

    STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·April 10, 2013

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024