BEUDAMED
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    MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    EASYLIFE

    FDA UDI
    Respironics, Inc.·00606959027862·EasyLife Mask with Headgear, Medium Wide, Japan

    Cook

    FDA UDI
    COOK INCORPORATED·00827002141216·Connecting Tube

    Copper Ni-Ti - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989025477·COPPER NITI 27 BAF 14 DIA L/L PK10

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0100430·Caddie Lid, Adjustable Cross Links

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH

    DRG AURICA ELISA TESTOSTERONE KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MARY HITCHCOCK HANOVER NH 1

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·November 7, 2012

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·Femoral Introducer Sheath and Hemostasis(FISH) Device

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·FEMORAL INTRODUCER SHEATH & HEMOSTASIS (FISH) DEVICE

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·FEMORAL INTRODUCER SHEATH AND HEMOSTASIS DEVICE

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·FEMORAL INTRODUCER SHEATH & HEMOSTASIS DEVICE (FISH)

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·7F FISH-SP DEVICE

    2124215-2013-05222

    FDA Adverse Event
    Malfunction ·GUIDANT PUERTO RICO BV·Product code DTB·April 10, 2013

    MAXIMO VR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·May 8, 2008

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 1, 2011

    Custom Kit, REF: K05-00843, Revision L, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DQO·April 15, 2008

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·May 29, 2021