BEUDAMED
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    AUTO-FIELD D AUTOMATED VISUAL DETECTOR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    RMO

    FDA UDI
    Rmo, Inc.·00885797100122·REMOV QUADHELIX KIT

    ACUMED

    FDA UDI
    Acumed LLC·10806378044250·KickStand Post 25°

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00810030810896·Hybrid Dual Taper Femoral Broach, Size 22

    Endo-Model Saddle Prosthesis

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575047802·Base components with inside anti-rotation pin, ...

    UNIPOLAR NEEDLES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PRIMADO SURGICAL DRILL

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    CROSSTEX SPS SPORVIEW CULTURE SET

    FDA Adverse Event
    Malfunction ·CROSSTEX SPS MEDICAL·Product code MRB·August 1, 2018

    FOUNDATION KNEE

    FDA Adverse Event
    Injury ·ENCORE MEDICAL, L.P.·Product code JWH·May 8, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NALL

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2012

    GPS PROCEDURAL STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·August 4, 2010

    DigitalDiagnost C50, Stationary X-ray System

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare·October 2, 2019

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    Easy Diagnost Eleva Universal Fluoroscopic applications

    FDA Recall
    Terminated ·Philips Medical Systems, Inc.·Product code KPR·October 30, 2013

    Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code LNH·August 7, 2013

    Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·December 19, 2012

    Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code MQB·August 14, 2012

    Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland), Inc.·Product code MUJ·February 11, 2014

    Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 24, 2012

    Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 24, 2012