15 results
·
7ms
·
Sources: EU EUDAMED, US FDA
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
FDA Enforcement
Class II
·Ongoing·CardioQuip, LLC·October 13, 2021
CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
FDA Enforcement
Class II
·Ongoing·CardioQuip, LLC·October 13, 2021
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
FDA Enforcement
Class II
·Ongoing·CardioQuip, LLC·December 27, 2023
CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
FDA Enforcement
Class II
·Ongoing·CardioQuip, LLC·October 13, 2021
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
FDA Enforcement
Class II
·Ongoing·CardioQuip, LLC·December 27, 2023
CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
FDA Enforcement
Class II
·Ongoing·CardioQuip, LLC·October 13, 2021
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
FDA Enforcement
Class II
·Ongoing·SIGHT DIAGNOSTICS LTD·August 3, 2022
Alinity hq Analyzer, REF: 09P68-01
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·August 28, 2024
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tools. The disposable cartridge containing the blood sample is loaded into the device through the loading slot. The device is operated through the touch screen interface. The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%/#, LYMPH %/#, MONO %/#, EO%/# and BASO%/#. In addition, the Sight OLO signals specific WBC abnormal cases by flagging the sample.
FDA Enforcement
Class II
·Ongoing·SIGHT DIAGNOSTICS LTD·April 27, 2022
NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E
FDA Enforcement
Class II
·Ongoing·Mc3 Inc·March 27, 2024
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E
FDA Enforcement
Class II
·Ongoing·Mc3 Inc·March 27, 2024
EasyTouch (ET) Insulin Syringe 29G 0.5ml ¿" (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
FDA Enforcement
Class II
·Ongoing·MHC Medical Products LLC·May 16, 2018
EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
FDA Enforcement
Class II
·Ongoing·MHC Medical Products LLC·May 16, 2018
IRON assay, Reference Numbers 6K95-41 and 6K95-30
FDA Enforcement
Class II
·Ongoing·Sentinel CH SpA·November 29, 2023
Alinity c Iron Reagent, Reference Number 08P3920
FDA Enforcement
Class II
·Ongoing·Sentinel CH SpA·November 29, 2023