BEUDAMED
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    Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart

    FDA 510(k)
    FDA Class 2 ·Radiology

    2.0 LACTOSORB SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036054496·

    Simpact Tri-Fin

    FDA UDI
    Life Spine, Inc.·00190837062668·300mm x 2.4mm Steinmann Pin, Threaded-Blunt, St...

    SunMed

    FDA UDI
    SUNMED, LLC·20889483000776·GUEDEL PVC SZ6 ORNGE 110mm P50

    NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SIMILE FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·December 5, 2018

    VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 60/28

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·January 13, 2016

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·October 8, 2014

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    BD NEXIVA SINGLE PORT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 26, 2024

    VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 60/28

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·January 18, 2019

    OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966

    FDA Recall
    Terminated ·Kerr Corp·Product code KLE·August 29, 2006

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 2021

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018