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Myocure, Inc.

United StatesFDA applicant, unverified

Devices
15

What Myocure, Inc. makes

Myocure, Inc. manufactures single-use surgical instruments for ophthalmic and general surgical procedures, including disposable blades, scalpels, and ultrasonic pachometers. Their portfolio includes ophthalmic-specific tools such as phaco-blades, surgical specula, and depth-guided knives, as well as anesthesia needles and skin markers for precision applications. The company also produces kits combining multiple instruments, such as The Saver Kit and The Ultimate, for streamlined surgical workflows.

Myocure’s devices are classified under FDA categories Class I, Class II, and Class III, with many authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry, reflecting their regulatory compliance in the United States. The company is headquartered in the US.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue15

Newest first, rows 1-15 of 15

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  • Myocur Blade Pac Ref K822392

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

  • Ophthalmic Phaco-Blade Ref K873385

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

  • Surgical Skin Marker Ref K864371

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

  • Myopach Ultrasonic Pachometer Ref K844112

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

  • Ophthalmic Surgical Ocular Markers Ref K863663

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

  • The Saver Kit Ref K863666

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

  • Ophthalmic Surgical Speculum Ref K863664

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

  • Ophthalmic Knife W/Removale Depth Guide Ref K853598

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

  • Anesthesia/Retrobulbar Needles Ref K880347

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

  • Ophthalmic Disposable Blades Ref K874056

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

  • Ophthalmic Tip & Blade Scalpels Ref K874057

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

  • The Ultimate Ref K863665

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

  • Cystotomes/Knifes Ref K880345

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

  • Ophthalmic Surgical Drape Ref K863662

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

  • Cannulas Ref K880346

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

Rows 1-15 of 15

Frequently asked questions

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

The registry currently lists 15 devices for Myocure, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Myocure, Inc.'s devices?

Among its 15 most recently registered devices, Myocure, Inc. has devices listed in FDA 510(k) (15 devices).

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

Among its 15 most recently registered devices, the classes recorded for Myocure, Inc.'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 Myocure, Inc. in the registry?

The most recently registered devices listed for Myocure, Inc. include MYOCUR BLADE PAC, OPHTHALMIC PHACO-BLADE, SURGICAL SKIN MARKER and MYOPACH ULTRASONIC PACHOMETER.

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