BEUDAMED
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    WRIST AUTOMATIC BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KIMURA SPATULA

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896013452·KIMURA SPATULA FLAT BLADE PLATINUM

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702256482·Elvarex 2/Thigh High/Profile, Slant, Open Toe, ...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702379891·ELVAREX 1/THIGH HIGH/OPEN TOE/DOTTED SILICONE B...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702598018·Elvarex 2/Knee High/Slant-Closed Toe/SoftFit-Sl...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K1230000·Rod Holder, Curved, 5.5 mm

    Phadia 1000

    FDA UDI
    Phadia AB·07333066001005·Phadia 1000

    JORGE

    FDA UDI
    The Wells Johnson Company·B458201238000·Cannula, Jorge, specify length, diameter, tip s...

    BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code EZW·May 22, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    FDA Adverse Event
    Malfunction ·COSTA RICA·Product code LTI·August 14, 2008

    Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments.

    FDA Enforcement
    Class II ·Terminated·Phadia US Inc·January 21, 2015

    Phadia 1000 Instrument, Article Number 12-3800-01.

    FDA Recall
    Terminated ·Phadia US Inc·Product code DHB·July 5, 2017

    Phadia 1000 Instrument, Article Number 12-3800-01.

    FDA Enforcement
    Class II ·Terminated·Phadia US Inc·January 24, 2018

    Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.

    FDA Enforcement
    Class II ·Terminated·Phadia Ab·September 4, 2019

    Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.

    FDA Recall
    Terminated ·Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden·Product code DHB·July 9, 2019

    Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments.

    FDA Recall
    Terminated ·Phadia US Inc·Product code DHB·November 20, 2014