BEUDAMED
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    3402 HANDHELD PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Monolith

    FDA UDI
    Nuvasive, Inc.·00887517677099·Monolith Core, Ø14x10mm

    PROCARE

    FDA UDI
    DJO, LLC·00888912038461·FOAM LIMB HOLDER, 24 PR

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690199069·AK3 Congruent Insert Trial Size 4, 10mm

    Pro-Retractor Deaver Retractor Blade

    FDA UDI
    KOROS U.S.A., INC.·10840199542625·Pro-Retractor Deaver Retractor Blade Small 1 x ...

    AMALGAMATOR MODEL SDC--

    FDA 510(k)
    FDA Class 1 ·Dental

    DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 6, 2013

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011

    CAPSUREFIX MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·August 8, 2014

    Candela Smoothbeam Laser System Model Numbers: 9914-00-0820 9914-06-0820 9914-07-0820 9914-08-0820 9914-10-0820 Units are the same except for color

    FDA Recall
    Terminated ·Candela Laser Corporation·Product code GEX·November 25, 2003

    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

    HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

    HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

    FDA Recall
    Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

    FDA Recall
    Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

    Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 4, 2018