BEUDAMED
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    Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·July 17, 2024

    Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The Monarch Airway Clearance System, Model 1000, is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physicians choice of treatment. It is indicated for patients having difficulty with secretion clearance or the presence of atelectasis caused by mucus plugging.

    FDA Enforcement
    Class II ·Terminated·HILL-ROM MANUFACTURING, INC.·December 6, 2017

    TLC-2000 Therapeutic Medical Laser System

    FDA Enforcement
    Class III ·Terminated·Theralase Inc.·February 26, 2020

    CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.

    FDA Enforcement
    Class I ·Terminated·Thoratec Switzerland GMBH·November 6, 2019

    VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·April 13, 2016

    2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·December 28, 2022

    Medtronic SynchroMed II, Model 8637-20, Programmable pump

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·January 3, 2024

    Medtronic SynchroMed II, Model 8637-40, Programmable pump

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·January 3, 2024

    Ami HTX.

    FDA Enforcement
    Class II ·Ongoing·Spectral Instruments Inc·June 25, 2025

    Lago X

    FDA Enforcement
    Class II ·Ongoing·Spectral Instruments Inc·June 25, 2025

    VITROS XT3400 Chemistry System, Product code 6844458

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics·September 2, 2020

    VITROS XT7600 Integrated System, Product code 6844461

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics·September 2, 2020

    PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1

    FDA Enforcement
    Class II ·Terminated·Whirlpool Corporation·August 26, 2020

    CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian; b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxide Delivery System; c. CMI-0100-PNX-HS-NO2H, Pro-Nox Hospital System without Oxygen Regulator; d. CMI-0100-PNX-HSWM, Pro-Nox Hospital System Wall Mount with Universal Mount (GCX) scavenger; e. CMI-0100-PNX-NHS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System (Non-hospital); f. CMI-0100-PNX-NHS-PS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System with Passive Scavenger; g. CMI-0100-PNX-US, Pro-Nox mixer, 6' high-pressure O2 and N2O hoses

    FDA Enforcement
    Class II ·Terminated·CAREstream Medical LLC·August 29, 2018

    Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·December 24, 2014

    ABL800 analyzer, model numbers 393-800 and 393-801.

    FDA Enforcement
    Class II ·Terminated·Radiometer America Inc·January 2, 2019

    Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI).

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·August 7, 2019

    Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·March 5, 2014

    VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·December 4, 2024

    Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.

    FDA Enforcement
    Class II ·Terminated·Synthes USA HQ, Inc.·July 24, 2013