8 results
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6ms
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Sources: EU EUDAMED, US FDA
Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30); g. SM-32-HF-B-D-KM (AeroDR X30); h. SM-40HF-B-D-KM (AeroDR X30); i. SM-50HF-B-D-KM (AeroDR X30); j. MobileDiagnost wDR.
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·May 8, 2024
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·September 24, 2025
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·September 24, 2025
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·September 24, 2025
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·September 24, 2025
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
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
FDA Enforcement
Class II
·Ongoing·Synthes USA HQ, Inc.·August 7, 2013
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Corp. Hq.)·October 2, 2024