BEUDAMED
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    SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Leukomed®

    FDA UDI
    BSN medical GmbH·04042809594355·LEUKOMED SKIN SENSITIVE STERILE 5X7.2CM WHITE 20

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702256475·Elvarex 2/Thigh High/Profile, Slant, Open Toe, ...

    CosmoLock Pedicle Screw System

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

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702557336·Elvarex 3/Knee High/Slant-Open Toe-Elephantiasi...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702598025·Elvarex 2/Knee High/Slant-Closed Toe/SoftFit-zi...

    BECKER BASKET

    FDA UDI
    The Wells Johnson Company·B458201239000·Cannula, Becker Basket, specify length, diamete...

    Phadia 250

    FDA UDI
    Phadia AB·07333066001029·Phadia 250

    INTEGRA TOTAL FOOT SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2

    FDA 510(k)
    FDA Class 2 ·Hematology

    BD 10ML SYRINGE LUER-LOK¿ TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 13, 2018

    EDS III CSF DRAIN SYS W/O V CATH

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC.·Product code JXG·May 22, 2013

    OT PING ENHANCED METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 27, 2014

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 14, 2011

    BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 18, 2021

    AIA-900

    FDA Adverse Event
    Malfunction ·TOSOH HI-TEC, INC.·Product code KHO·May 30, 2024

    AIA-900

    FDA Adverse Event
    Malfunction ·TOSOH HI-TEC, INC.·Product code KHO·January 26, 2026

    Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.

    FDA Enforcement
    Class II ·Terminated·Phadia Ab·April 11, 2018

    Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.

    FDA Recall
    Terminated ·Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden·Product code DHB·November 20, 2017

    Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·July 1, 2020