FDA 510(k) Applications Submitted by Agatha Szeliga

FDA 510(k) Number Submission Date Device Name Applicant
K190729 03/21/2019 SPY Portable Handheld Imaging (SPY-PHI) System Novadaq Technologies ULC. (now a part of Stryker)
K200737 03/23/2020 SPY Portable Handheld Imaging (SPY-PHI) System Novadaq Technologies ULC. (now a part of Stryker)
K191046 04/19/2019 L10 LED Light Source with AIM, L11 LED Light Source with AIM Stryker
K222406 08/09/2022 Clarius AI Clarius Mobile Health Corp.
K202244 08/10/2020 SPY-PHI System with SPY-PHI Fluorescence Assessment Software Novadaq Technologies ULC (now a part of Stryker)
K192174 08/12/2019 SPY Portable Handheld Imaging (SPY-PHI) System Novadaq Technologies ULC. (now a part of Stryker)
K232704 09/05/2023 Clarius Ultrasound Scanner Clarius Mobile Health Corp.
K182606 09/21/2018 PINPOINT Endoscopic Fluorescence Imaging System Novadaq Technologies ULC (now a part of Stryker)
K182907 10/17/2018 SPY Elite Intraoperative Perfusion Assessment System Novadaq Technologies ULC. (now a part of Stryker)
K213436 10/22/2021 Clarius Ultrasound Scanner Clarius Mobile Health Corp.


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