68 results
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16ms
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Sources: EU EUDAMED, US FDA
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
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
CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I collagen (nominally 99%) derived from tendon and small quantities of glycosaminoglycans (GAGs: chondroitin sulfate and sodium hyaluronate). The device functions as a resorbable scaffold that is replaced by the patient s own tissue.The CMI device is designed to function as an absorbable template to facilitate host meniscus tissue regeneration in patients who have an irreparable meniscus tear or loss of meniscus tissue. The CMI meniscus tissue through the implant s absorption and replacement by patient s native tissue.
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·March 21, 2018
Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023