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Carapace, Inc.

United StatesFDA applicant, unverified

Devices
22

What Carapace, Inc. makes

Carapace, Inc. manufactures single-use medical supplies for surgical, wound care, and patient care settings, including sterile cotton balls, gauze trays, debridement kits, cast padding, and instrument sets. Their product line also covers labor and delivery trays, cataract surgical trays, face masks, synthetic cast tape, and lap sponges. These items are designed for procedural and postoperative use in clinical environments.

The company’s products are classified under FDA’s Class I and Class II categories, with many authorised via the 510(k) pathway. Their devices are listed in the FDA’s 510(k) database, and the company operates from the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Frequently asked questions

How many devices does Carapace, Inc. have in the registry?

The registry currently lists 22 devices for Carapace, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Carapace, Inc.'s devices?

Among its 22 most recently registered devices, Carapace, Inc. has devices listed in FDA 510(k) (22 devices).

What risk classes do Carapace, Inc.'s devices fall under?

Among its 22 most recently registered devices, the classes recorded for Carapace, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Carapace, Inc. in the registry?

The most recently registered devices listed for Carapace, Inc. include VARIOUS DISPOSABLE KITS/TRAYS/INSTRU, CARAPACE STERILE COTTON BALLS, SURGICAL FACE MASK and CARAPACE STERILE GAUZE TRAYS.

Generated automatically from registry data and not verified by a human reviewer.