BEUDAMED
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    Albumin BCP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PYRAMID MKII LOFLOSORB G/V

    FDA UDI
    Intersurgical Incorporated·05030267117062·PYRAMID MKII LOFLOSORB G/V

    SAIPH

    FDA UDI
    MATORTHO LTD·05055455506008·SAIPH Femur Cemented Yellow Left Size 2

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101063·KNAPP RETRACTOR 4-PRONG SHARP

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K1230010·Rod Holder, Straight, 5.5 mm

    Eargo 8

    FDA UDI
    Eargo, Inc.·00850010429793·Eargo 8 Charger, Power Cord & Adaptor

    ROCKWOOD CLAVICLE PINS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER

    FDA 510(k)
    FDA Class 2 ·Hematology

    OMNIFIX®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FMF·March 6, 2026

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 22, 2014

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 27, 2013

    PVC, CLEAR, CONTRAST INJECTION TUBING

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code FPK·July 21, 2011

    Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773 G15000 G14867 G14951 G17852

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·February 12, 2020

    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

    Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021