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Checkpoint Surgical, Inc.

United States·US-MF-000008429

Last updated May 30, 2026

What Checkpoint Surgical, Inc. makes

Checkpoint Surgical, Inc. manufactures nerve-locating systems, including handheld probes and intraoperative leads designed for identifying peripheral nerves during surgery. Their portfolio also includes single-use surgical forceps for soft-tissue manipulation and nerve repair kits, as well as animal-derived nerve guides. Additionally, they produce protective membranes—such as chitosan-based barriers and hydrogel membranes—to shield nerves during procedures.

The company’s devices are classified under FDA regulations as Class I, Class II, and Class IIa, with listings in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system. Their products are intended for use in surgical settings and comply with applicable medical device regulations in the United States and European Union.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 6050 , Oak Tree Blvd, Independence, United States
Website: www.checkpointsurgical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1 216 378 9107
PRRC Contact: Matthew Hildebrand
EUDAMED SRN: US-MF-000008429
FDA FEI Number: —
DUNS Number: 832575364

Catalogue (16)

Device	Model / Reference	Registries	Class	Status
Guardian Probe Extension Ball Tip, 12 cm	9505	FDA UDI	Class II	Active
Checkpoint Guardian	9095	FDA UDI	Class II	Active
Guardian Probe Extension, 12 cm	9504	FDA UDI	Class II	Active
Checkpoint Nerve Repair Kit	NS4030K1	FDA UDI	N/A	Active
Checkpoint Gemini	9092	FDA UDI	Class II	Active
Guardian Intraoperative Lead, Medium	9525	FDA UDI	Class II	Active
Checkpoint NeuroShield Chitosan Membrane	NS4030	FDA UDI	Class II	Active
Guardian Probe Extension, 4 cm	9506	FDA UDI	Class II	Active
Checkpoint Nerve Repair Kit	NS3020K2	FDA UDI	N/A	Active
Guardian Intraoperative Lead, Small	9524	FDA UDI	Class II	Active
Checkpoint NeuroShield Chitosan Membrane	NS3020	FDA UDI	Class II	Active
ProVeil Hydrogel Membrane	PV4030	FDA UDI	Class II	Active
Checkpoint Edge Nerve Cutting Kit	9250	FDA UDI	Class I	Active
Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large	K212355	FDA 510(k)	Class II	Active
Checkpoint Surgical Nerve Stimulator	9094	EUDAMEDFDA UDI	Class IIa	Active
Checkpoint Surgical Head & Neck Nerve Stimulator	9394	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Wmde B.v. NL

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Recalls (2)

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

Checkpoint Surgical, Inc. has two FDA recall records, both initiated on February 24, 2025. One record is marked as open, and another is classified. The reasons provided involve concerns that the adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, which could result in exposed metal and a risk of electrical current leakage.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Feb 24, 2025	Z-1466-2025	—	open, classified	Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or confusing muscle responses, potentially compromising the effectiveness of the intended use as the surgeon could take an incorrect clinical action.
Feb 24, 2025	Z-1467-2025	—	open, classified	Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or confusing muscle responses, potentially compromising the effectiveness of the intended use as the surgeon could take an incorrect clinical action.