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CENTERLINE BIOMEDICAL

Last updated September 17, 2026

Information

Country: US
Address: 4535 Renaissance Pkwy, Cleveland, OH, 44128
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LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3012154226
DUNS Number: —

Catalogue (19)

Device	Model / Reference	Registries	Class	Status
IOPS Viewpoint	C00752	FDA UDI	Class II	Active
IOPS™ Software Application	SW-1	FDA UDI	Class II	Active
IOPS Viewpoint	C01252	FDA UDI	Class II	Active
Iops™	ATW-2	FDA UDI	Class II	Active
Iops™	SCC-1	FDA UDI	Class II	Unknown
IOPS Viewpoint	C01251	FDA UDI	Class II	Active
Iops®	T02111	FDA UDI	Class II	Active
IOPS Viewpoint	C00751	FDA UDI	Class II	Active
Iops®	H01035	FDA UDI	Class II	Active
IOPS Mobile Cart	MC-1	FDA UDI	Class II	Active
Iops™	TP-1	FDA UDI	Class II	Active
Iops™	RCC-1	FDA UDI	Class II	Unknown
Iops™	SSH-1	FDA UDI	Class II	Active
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	FDA 510(k)	Class II	Active
Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)	K241243	FDA 510(k)	Class II	Active
Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)	K242133	FDA 510(k)	Class II	Active
Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle	K190106	FDA 510(k)	Class II	Active
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	FDA 510(k)	Class II	Active
Intra-Operative Positioning System (IOPS®)	K243842	FDA 510(k)	Class II	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 11, 2025	Z-1760-2025	—	open, classified	Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.