BEUDAMED
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    CONTIPLEX FX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    n/a

    FDA UDI
    HANS RUDOLPH, INC.·00874750007158·3700 OEM PNT HTD 22 LG/ 35 SM

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172971185·

    TROPHON

    FDA 510(k)
    FDA Class 2 ·Radiology

    STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)

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

    BIPAP A30-S SILVER

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

    BIPAP A30, SILVER

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

    BIPAP A30

    FDA Adverse Event
    Death ·RESPIRONICS, INC.·Product code MNS·September 13, 2023

    IMPAX CV OUTBOUND(RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 9, 2013

    SUMMIT CEMENTED STEM SZ4 HI

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·May 18, 2011

    Davol Salute Laproscopic 38cm Sterile Implant Cartridge 60 Q-ring;5/Box, Item Number: 0113059

    FDA Recall
    Terminated ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code GDW·July 16, 2007

    BIPAP A30-S SILVER

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

    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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025