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Centerline Biomedical, Inc.

6 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) (K254089)Centerline Biomedical, Inc.2026-02-17
Intra-Operative Positioning System (IOPS®) (K243842)Centerline Biomedical, Inc.2025-03-06
Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) (K242133)Centerline Biomedical, Inc.2024-10-11
Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) (K241243)Centerline Biomedical, Inc.2024-07-24
Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) (K230309)Centerline Biomedical, Inc.2023-06-21
Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle (K190106)Centerline Biomedical, Inc.2019-06-24

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Every clearance here is in the API, with alerts when new ones post.