BEUDAMED
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    PHILIPS HEARTSTART SMARTPADS III

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Integra® Spider™ Limted Wrist Fusion System

    FDA UDI
    INTEGRA LIFESCIENCES CORPORATION·10381780064831·The Integra Spider Limited Wrist Fusion bone sc...

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496072812·STRIPE GAME EOS, SIZE M, NERO, GRADUATED COMPRE...

    IRIS RETRACTING PHACOEMULSIFICATION SLEEVE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CAROTID GUIDING SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARTISAN

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 23, 2024

    ASR ACETABULAR CUPS 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 23, 2013

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·April 29, 2011

    KAPPA 700 SR

    FDA Adverse Event
    Malfunction ·MEDTRONIC S.A.·Product code DXY·July 10, 2008

    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014

    Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

    VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 10758750006250 / Product Code 6802893 - Calibrators For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Intact PTH is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively

    FDA Enforcement
    Class II ·Terminated·ORTHO-CLINICAL DIAGNOSTICS·January 4, 2017

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015