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Cure Medical, LLC

United StatesFDA 510(k) applicant, unverified

Devices
4
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Cure Medical, LLC makes

Cure Medical, LLC manufactures a range of urethral catheters, including standard, female, male, coudé, pediatric, and hydrophilic-coated variants, as well as a closed-system catheter design. These devices are intended for urinary drainage and bladder irrigation procedures.

The company’s catheter portfolio is classified under FDA Class II devices and is authorised through the 510(k) clearance process. The products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue4

Newest first, rows 1-4 of 4

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Cure Medical, LLC, the earliest on 2012-09-19 and the most recent on 2014-11-11. By recorded status: 2 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2014

    • 11 Nov 2014 Z-0496-2015 Class II Terminated Some of the intermediate boxes within lot 140417-3, were labeled as P8, a French Size 8 pediatric catheter but actually contain P10, French Size 10 pediatric catheters. Trying to use a P10 catheter for bladder drainage, where P8 catheters have been prescribed, may result in acute urinary retention; and, forced attempts to insert the French Size 10 catheter lead to urethral trauma. Distribution: Nationwide Distribution Submission number: K110653

  • 2012

    • 19 Sep 2012 Z-0004-2013 Class II Terminated The firm initiated the product recall because labeling on some of the intermediate boxes of catheters identify the contents to be M16C, a coud-tip catheters while the actual contents are M16Fr male, 16Fr, straight-tip catheters with the pouch and the case box labeled as M16Fr male, 16Fr, straight-tip catheters. Distribution: Nationwide Distribution Submission number: K072539

Frequently asked questions

How many devices does Cure Medical, LLC have in the registry?

The registry currently lists 4 devices for Cure Medical, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Cure Medical, LLC's devices?

Among its 4 most recently registered devices, Cure Medical, LLC has devices listed in FDA 510(k) (4 devices).

What risk classes do Cure Medical, LLC's devices fall under?

Among its 4 most recently registered devices, the classes recorded for Cure Medical, LLC's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Cure Medical, LLC?

FDA recall records list 2 recalls initiated by Cure Medical, LLC, the most recent initiated on 2014-11-11. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Cure Medical, LLC in the registry?

The most recently registered devices listed for Cure Medical, LLC include CURE CATHETER, CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED and CURE CATHETER CLOSED SYSTEM.

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