BEUDAMED
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    Shofu Block HC Hard

    FDA 510(k)
    FDA Class 2 ·Dental

    CHEN MEMBRANE FOLDER

    FDA UDI
    W.H. Holden, Inc.·D9282004700·

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319742754·Hohmann-Aldinger Bone Lever 10-3/4" (26.9cm), b...

    HiPoint 70 reperfusion catheter with Tenzing 7

    FDA UDI
    ROUTE 92 MEDICAL·00853799007947·HiPoint 70 reperfusion catheter with Tenzing 7;...

    GTX 12 GIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DS2ADV AUTO CPAP

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·May 27, 2024

    DREAMSTATION 2 ADV AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·March 3, 2025

    DS2ADV AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·October 8, 2024

    DS2ADV AUTO CPAP

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·July 30, 2024

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 1, 2013

    STAPLE, IMPLANTABLE

    FDA Adverse Event
    Death ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 16, 2016

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021