BEUDAMED
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    POWDER FREE BLACK NITRILE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    5530 3L SYRINGE

    FDA UDI
    HANS RUDOLPH, INC.·00817136021072·5530 OMI WHITE 3L SYR-OMI ADPT

    All-Purpose Arch

    FDA UDI
    Noras MRI products GmbH·04251269201073·

    All-Purpose Arch

    FDA UDI
    Noras MRI products GmbH·04251269205668·

    HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POLARIS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCREW, UNKNOWN TYPE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019

    SCREW, UNKNOWN TYPE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019

    BD¿ LUER-LOK SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·March 1, 2022

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014

    GALILEO NEO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·May 15, 2013

    CLEAR CARE NO RUB

    FDA Adverse Event
    Injury ·CIBA VISION·Product code LPN·May 26, 2011

    BD¿ LUER-LOK SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·February 23, 2022

    BD¿ LUER-LOK SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·February 23, 2022

    Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2015

    Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014

    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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021