BEUDAMED
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    UNICOMPARTMENTAL KNEE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180502983·Distractor Tip, Lamina, Long, No Offset, Left

    CLEARFIL ST OPAQUER

    FDA 510(k)
    FDA Class 2 ·Dental

    KSEA MINIATURE NEUROENDOSCOPE

    FDA 510(k)
    FDA Class 2 ·Neurology

    LINEAR 3-6

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 8, 2022

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    FDA Adverse Event
    Malfunction ·OPTONOL LTD.·Product code KYF·March 21, 2017

    BD¿ ALLERGY SYRINGE WITH NEEDLE, TRAY

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·January 10, 2018

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·April 23, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·March 31, 2011

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

    PROSTHESIS, INTERVERTEBRAL DISC

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MJO·November 15, 2017

    PROSTHESIS, INTERVERTEBRAL DISC

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MJO·November 15, 2017

    PROSTHESIS, INTERVERTEBRAL DISC

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MJO·November 15, 2017

    PatientNet Monitoring System - PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx.

    FDA Recall
    Terminated ·General Electric Medical Systems Information Technology·Product code MSX·February 27, 2004

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012