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Calgon Vestal Div.

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Devices
19

What Calgon Vestal Div. makes

Calgon Vestal Div. manufactures wound care dressings, including antimicrobial and absorbent products like the BILL EVANS-KLENZ, EPI-LOCK, FORTEX, MON-KLENZ, AMERSE, KALTOSTAT, and HYDRASORB. Their portfolio also includes decontamination systems such as the VESTA-SYDE interim disinfection device and LPH solutions.

These products are regulated under FDA Class I and Unclassified (U) devices, with most listed via the 510(k) pathway. The company’s devices are based in the United States and appear in the FDA’s 510(k) registry.

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

Catalogue19

Newest first, rows 1-19 of 19

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  • Bill Evans-Klenz Ref K944033

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

  • Epi-Lock Wound Dressing Ref K926034

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

  • Fortex(Tm) Wound Dressing Ref K914314

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

  • Mon-Klenz Ref K941163

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

  • Amerse Ref K931477

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

  • Kaltostat Wound Dressing Ref K910059

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

  • Vesta-Syde(R) Interim Instr Decontamination System Ref K931816

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

  • Kaltocarb Wound Dressing Ref K894347

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

  • Kaltostat Wound Dressing Ref K904488

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

  • Lph Ref K931342

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

  • Hydrasorb Sterile Dressing Ref K931599

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

  • Kaltostat(Tm) Wound Dressing Ref K892364

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

  • Saf-Gel Hydrating Dermal Wound Dressing Ref K942270

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

  • Lonza Formulation R-82 Ref K932277

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

  • Kaltostat Wound Packing Ref K910080

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

  • Kaltostat Fortex Wound Dressing Ref K921009

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

  • Alsa-Klenz Ref K944494

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

  • Vesphene Ii Ref K931573

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

  • Kaltostat Wound Packing Ref K892868

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

Rows 1-19 of 19

Frequently asked questions

How many devices does Calgon Vestal Div. have in the registry?

The registry currently lists 19 devices for Calgon Vestal Div.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Calgon Vestal Div.'s devices?

Among its 19 most recently registered devices, Calgon Vestal Div. has devices listed in FDA 510(k) (19 devices).

What risk classes do Calgon Vestal Div.'s devices fall under?

Among its 19 most recently registered devices, the classes recorded for Calgon Vestal Div.'s devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Calgon Vestal Div. in the registry?

The most recently registered devices listed for Calgon Vestal Div. include BILL EVANS-KLENZ, EPI-LOCK WOUND DRESSING, FORTEX(TM) WOUND DRESSING and MON-KLENZ.

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