BEUDAMED
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    RODIN™ Expandable Lumbar Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRIAL HEAD DEF.STEM 12/14 D.28 +3,5

    FDA UDI
    FOURNITURES HOSPITALIERES INDUSTRIE·03661489313592·

    S-MONOVETTE EDTA K2-GEL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ECG Cables and Leadwires

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·March 10, 2009

    QUICK FLEX LV LEAD

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·November 6, 2014

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·September 1, 2011

    FLOGARD

    FDA Adverse Event
    Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·July 17, 2013

    MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    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

    ACCOLADE DR SL MRI (Model L311)

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