Centerline Biomedical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: IOPS Visionary System (MC-3), Intra-Operative Positioning System (IOPS®), Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad)
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Centerline Biomedical, Inc. Cardiovascular ✕
6 devices
Cleared
Feb 17, 2026
IOPS Visionary System (MC-3)
Cardiovascular
60d
Cleared
Mar 06, 2025
Intra-Operative Positioning System (IOPS®)
Cardiovascular
83d
Cleared
Oct 11, 2024
Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad)
Cardiovascular
81d
Cleared
Jul 24, 2024
Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)
Cardiovascular
82d
Cleared
Jun 21, 2023
Intra-Operative Positioning System (IOPS®) (MC-1)
Cardiovascular
138d
Cleared
Jun 24, 2019
Intra-Operative Positioning System
Cardiovascular
153d