BEUDAMED
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    ASCENDX VCF REDUCTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Bur PM2-70 80K Carb Ø6.0 St

    FDA UDI
    Bien-Air Surgery SA·17630055503685·

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950017362·RETRACTOR CHEEK SIMPLEX 4-1/2" 11.5CM STAINLESS...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694002011·ISO Chin Plate with Window, 4mm Step

    DREAMSTATION AUTO BIPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 30, 2025

    EXEL I.V. ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PC ECG 1200

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 8, 2013

    GORE VIABAHN® ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·W.L. GORE & ASSOCIATES·Product code NIP·September 18, 2014

    8800

    FDA Adverse Event
    Malfunction ·GE MED SYSTEMS (INDIA) PRIVATE LTD.·Product code JAA·May 13, 2011

    M/DN Intramedullary Fixation Humeral Nail

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HSB·March 16, 2004

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    Bleph Pack, part number AMS3325(B

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·August 29, 2012

    Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation

    FDA Enforcement
    Class II ·Terminated·Primus Corporation·November 11, 2020

    Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 1, 2025

    Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

    Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018