BEUDAMED
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    Biomonitor III, Biomonitor IIIm

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Securi-T

    FDA UDI
    HOLLISTER INCORPORATED·00610075069514·Hydrocolloid Skin Barrier

    Intraoral Scan Body 3.3

    FDA UDI
    RP - CONEXOES RESTAURADORAS LTDA·07901059075243·

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776165611·Thorlakson Simple Hand Retr DE

    Screwdriver

    FDA UDI
    Treace Medical Concepts, Inc.·00810111225021·5.0MM VPCS SCREWDRIVER, NON-CANNULATED

    THORLAKSON RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896019720·THORLAKSON RETRACTOR DOUBLE ENDED

    SkinStylus SteriLock MicroSystem

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    microTargeting™ Position Display Encoder

    FDA UDI
    FHC, INC.·00873263004449·Position Display Encoder for microTargeting(TM)...

    DUROM ACETABULAR COMPONENT 60/54, CODE T

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·August 30, 2018

    HARMONIC ACE 5MM SHEAR

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 31, 2020

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·October 20, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 1, 2013

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021