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Pollak (Intl.), Ltd.

Country not established FDA

Devices
31
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment

What Pollak (Intl.), Ltd. makes

Pollak (Intl.), Ltd. manufactures single-use medical and first-aid supplies, including sterile examination gloves, urine specimen containers, gauze swabs in various sizes and ply, and disposable razors. The company also produces wound care items like first aid bandages, dressing change sets, and suture removal sets, alongside specialized swabs such as CULSWAB and PROFILE SWAB. Additional products include the UMBICUT for umbilical care, PEDIWET (gauze impregnated with petrol), and the VECAFIX adhesive.

The company’s portfolio consists of devices classified as Class I, Class II, and unclassified (U), with regulatory submissions recorded in the FDA’s 510(k) registry. These products are intended for use in clinical, surgical, and home settings, adhering to U.S. medical device regulations. The manufacturer is based in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue31

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FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Pollak (Intl.) .ltd Tel Aviv · IL FEI 3043585890

Frequently asked questions

How many devices does Pollak (Intl.), Ltd. have in the registry?

The registry currently lists 31 devices for Pollak (Intl.), Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Pollak (Intl.), Ltd.'s devices?

Among its 31 most recently registered devices, Pollak (Intl.), Ltd. has devices listed in FDA 510(k) (31 devices).

What risk classes do Pollak (Intl.), Ltd.'s devices fall under?

Among its 31 most recently registered devices, the classes recorded for Pollak (Intl.), Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Pollak (Intl.), Ltd. in the registry?

The most recently registered devices listed for Pollak (Intl.), Ltd. include CULSWAB CAT.#978 & 979, STERILE EXAMINATION GLOVE #5121-5126, URINE SPECIMEN CONTAINER #'S 1013-1016 and FIRST AID BANDAGE CAT.#198 OR 199.

Which FDA establishments are linked to Pollak (Intl.), Ltd.?

1 FDA establishment is linked to Pollak (Intl.), Ltd. in the registry; they are listed on the company page.

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