BEUDAMED
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    AXINON® LDL-p Test System

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    n/a

    FDA UDI
    Ortho Development Corporation·00822409067862·Stem Extension Trial Diameter 21x80mm

    n/a

    FDA UDI
    Ortho Development Corporation·00822409070633·Snap-on Fem Augment Trial 8mm Posterior Size 1

    WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    T2 FEMORAL NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MESA Small Stature Spinal System

    FDA UDI
    VB Spine LLC·10888857187023·Over Cricket Locker

    SCREW, CORTICAL

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·October 25, 2017

    SCREW, CORTICAL

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·October 25, 2017

    SCREW, CORTICAL

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·October 25, 2017

    SCREW, CORTICAL

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·October 25, 2017

    CONTOURLOCK FEMORAL OSTEO PLATE RGHT S/M

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·October 25, 2017

    I-STAT 6+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·September 28, 2021

    BD MICROLANCE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·December 22, 2021

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 29, 2014

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 8, 2013

    Maquet Coronary Perfusion Cannulae with Balloon Tip, with either self-inflating balloon tip or cone distal tips, straight or right angle, available with proximal end fittings for either 1/4 inch connector or male luer fitting, Model numbers 210800, 210801, 210802, 210803, 210804, 210805, 210806, 210807, 210810, 210811, 210812, 210813, 210814, 210815, 210816, 210817, 215800, 215802, 215803, 215804, 215805, 215806, 215807, 215810, 215811, 215812, 215813, 215814, 215815, 215816, and 215817.

    FDA Recall
    Terminated ·Maquet Cardiovascular·Product code DWF·May 19, 2009

    PREFILLED FORMALIN CONTAINER 60 ML FILL IN 120 ML (4 OZ)

    FDA Adverse Event
    Malfunction ·E K INDUSTRIES, INC.·Product code IFP·March 3, 2023

    SCREW, CANCELLOUS

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·October 25, 2017

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025