BEUDAMED
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    Piccolo Composite® Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768451·GENUMEDI PSS GREEN I

    Denovo Preformed Matrix Band

    FDA UDI
    Denovo Dental, Inc.·00810059290976·Denovo Preformed Matrix Band - Adult 1/4, Size 1

    n/a

    FDA UDI
    Ortho Development Corporation·00822409070534·Snap-on Fem Augment Trial 4mm Distal Size 7

    ENDO-CHX

    FDA 510(k)
    FDA Unclassified ·Unknown

    SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    RUSCH GREENLED HANDLE, MEDIUM

    FDA Adverse Event
    Malfunction ·TRUPHATEK INTERNATIONAL LTD.·Product code CCW·April 10, 2018

    RUSCH GREENSPEC FO HANDLE MEDIU

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CCW·March 20, 2018

    RUSCH GREENSPEC FO HANDLE MEDIU

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CCW·March 20, 2018

    CONTAK RENEWAL

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 20, 2011

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·June 7, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 14, 2014

    MAMBA? FLEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·September 11, 2025

    BAB FLEXIBLE FABRIC BANDAGES

    FDA Adverse Event
    Injury ·KENVUE·Product code KGX·November 1, 2024

    BAB FLEXIBLE FABRIC BANDAGES

    FDA Adverse Event
    Injury ·KENVUE·Product code KGX·November 1, 2024

    BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION MAX

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON CONSUMER INC·Product code KGX·October 3, 2023

    BD BBL¿ VENTING UNIT

    FDA Adverse Event
    Injury ·BECTON, DICKINSON & CO.·Product code JTA·January 16, 2018

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 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

    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