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Winn Hirsch & Assoc.

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Devices
11

What Winn Hirsch & Assoc. makes

Winn Hirsch & Assoc. manufactures medical textiles and wound care products, including sterile and non-sterile gauze conversions, burn blankets, and cellulose-based eye sticks. Their portfolio also covers neurosurgical sponges and padded cotton under-cast materials, as well as stainless steel wires and temporary myocardial electrodes for cardiac procedures.

The company’s devices are regulated under FDA classifications ranging from Class I to Class III and unclassified (U), with many listed via the 510(k) pathway. Products are distributed in the United States, where the manufacturer is based.

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

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  • Gauze Conversion Class Ii Sterile Ref K832213

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Zanlex, Zan-Tex & Zandex Ref K830511

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Neurosponges Ref K812391

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Cellulose Eye Stick Ref K761155

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cotton Under Cast Padding Ref K800195

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Blanket, Burn Ref K760365

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Gauze Conversion Class I-Non-Sterile Ref K832214

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Type 316l Stainless Steel Wire Ref K880309

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Neurosponge Paddie Ref K812390

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Type 316l Cotter Wire Ref K864375

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Electrode, Temporary Myocardial Ref K760513

    Active Regimes: 510(k) Registry: 510(k) Class:III

Rows 1-11 of 11

Frequently asked questions

How many devices does Winn Hirsch & Assoc. have in the registry?

The registry currently lists 11 devices for Winn Hirsch & Assoc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Winn Hirsch & Assoc.'s devices?

Among its 11 most recently registered devices, Winn Hirsch & Assoc. has devices listed in FDA 510(k) (11 devices).

What risk classes do Winn Hirsch & Assoc.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Winn Hirsch & Assoc.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.

What are the newest devices from Winn Hirsch & Assoc. in the registry?

The most recently registered devices listed for Winn Hirsch & Assoc. include GAUZE CONVERSION CLASS II STERILE, ZANLEX, ZAN-TEX & ZANDEX, NEUROSPONGES and CELLULOSE EYE STICK.

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