BEUDAMED
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    3M WOUND CONTACT MATERIAL, PRODUCT #563X

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    eMurmur ID

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SUCTION APPARATUS, POWERED BY COMP. AIR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    132 SIZE 5 SECUR-FIT ADVANCED STEM

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·June 18, 2014

    TRANSSEPTAL NEEDLE, BRK 1, 71CM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·October 12, 2010

    SIGMA STAB GVF INS 3 10MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM·Product code JWH·December 20, 2012

    NONE

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code GCJ·February 26, 2024

    Ocular Plastic Pack, part number AMS3868(A

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

    DeVilbiss Model DV5x Series CPAP with Heated Humidifier Device is intended to treat Obstructive Sleep Apnea (OSA) in patients weighing 30 Kg and above. The device creates a positive pressure in the patient's airway to prevent collapse of the airway while the patient is sleeping. The heated humidifier provides additional humidity to the air supplied to the patient. The heated humidifier has a removable water chamber for filling with water and ease of cleaning.

    FDA Recall
    Terminated ·Sunrise Medical HHG Inc. dba DeVilbiss Healthcare·Product code BZD·March 11, 2011

    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