BEUDAMED
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    RENAISSANCE X SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925016088·MCGEE PISTON SLIM 6 MM DIAMETER 475 MM LENGTH S...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319720714·Rochester Ochsner (Kocher) Forceps 10" (25cm), ...

    PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VERTE-STACK SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZIMMER SKIN GRAFT MESHER

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code FZW·May 29, 2013

    SYNCHRON® SYSTEMS RHEUMATOID FACTOR (RF) REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHR·June 25, 2011

    VIBRANT SOUNDBRIDGE

    FDA Adverse Event
    Injury ·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·September 2, 2008

    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

    2.7MM - 10 HOLE Y COMPRESSION PLATE

    FDA Adverse Event
    Injury ·OSTEOMED, LLC·Product code HRS·August 1, 2025

    A7 ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017

    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

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012