BEUDAMED
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    Arthrex Univers Revers CA Heads and Adapters

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ProLift Trial

    FDA UDI
    Life Spine, Inc.·00190837088576·

    SPI EASY TEMPORARY CAP

    FDA 510(k)
    FDA Class 2 ·Dental

    MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BASIX COMPAK INFLATION SYRINGE KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·March 14, 2011

    PENUMBRA SMART COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·December 11, 2015

    AMIA AUTOMATED PD CYCLER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·December 15, 2020

    AMIA AUTOMATED PD CYCLER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·January 12, 2023

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DXY·June 7, 2013

    REPLY

    FDA Adverse Event
    Malfunction ·SORIN CRM S.R.L.·Product code NVZ·June 24, 2011

    ALARIS SYSTEM PUMP MODULE

    FDA Adverse Event
    Other ·CARDINAL HEALTH ALARIS PRODUCT·Product code FRN·September 5, 2008

    AMIA AUTOMATED PD CYCLER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·February 15, 2024

    DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; DrugSmart 9 Test Cup (BUP), Item No. 60960D; DrugSmart Cup 10, Item No. 61093D-3C These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    Medical Linear Accelerator

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 14, 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