BEUDAMED
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    VIAMO SSA-640A V4.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2

    FDA 510(k)
    FDA Class 2 ·Hematology

    LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    FINESSE REFLEX DSP FORCEPS

    FDA Adverse Event
    Injury ·ALCON GRIESHABER AG·Product code HNR·September 12, 2023

    COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code MPB·February 13, 2017

    INTELLAMAP ORION¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DRF·February 18, 2016

    RADISTOP RADIAL COMPRESSION SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL SYSTEMS AB·Product code GAX·May 14, 2013

    CS100

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP·Product code DSP·September 22, 2014

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 13, 2011

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    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

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025