BEUDAMED
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    rainbow MCT

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROFYLE

    FDA UDI
    Stryker GmbH·04546540256171·Drill Guide

    NELSON-METZENBAUM SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896083615·NELSON-METZENBAUM SCISSORS CURVED BLADE POWER C...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694091015·Profile Plus Organizer Block

    TISSUE FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896060722·TISSUE FORCEPS MICROSCOPIC STRAIGHT TUNGSTEN CA...

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 5, 2016

    ELECSYS CORTISOL TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SMR SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code PHX·May 26, 2026

    COLLEAGUE PRE P1.7

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

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 17, 2014

    ANEURX

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 1, 2013

    M2A-MAGNUM PF CUP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 10, 2017

    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

    FDA Enforcement
    Class II ·Completed·Mako Surgical Corporation·November 25, 2020

    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