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FDA 510(k) Applications Submitted by April Malmborg
FDA 510(k) Number
Submission Date
Device Name
Applicant
K200310
02/06/2020
1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality
Stryker
K230605
03/03/2023
1788 4K Camera System with Advanced Imaging Modality
Stryker
K230754
03/17/2023
L12 LED Light Source with AIM
Stryker
K181258
05/11/2018
ConnectedOR Hub with Device and Voice Control
Stryker
K231854
06/23/2023
1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
Stryker
K182160
08/09/2018
1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM
Stryker
K192292
08/23/2019
L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable
Stryker
K023288
10/02/2002
COBRA BIPOLAR CLAMP, MODEL 15902
BOSTON SCIENTIFIC EP TECHNOLOGIES
K040104
01/20/2004
COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0
BOSTON SCIENTIFIC CORP.
K040219
02/02/2004
COBRA SURGICAL PROBE
BOSTON SCIENTIFIC CORP.
K032207
07/18/2003
COBRA COOLED SURGICAL PROBE, MODEL M004159670
BOSTON SCIENTIFIC CORP.
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