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Omega-Med Intl., Inc.

United StatesFDA applicant, unverified

Devices
9

What Omega-Med Intl., Inc. makes

Omega-Med Intl., Inc. manufactures medical devices including surgical accessories like SUTURE-AID BOOTIES, instrument covers (silicone, disposable, and fabric types), OMED SILICONE LOOPS, OMED IDENT-I-BAND, OMED DISPOSABLE BULLDOG, and the COMPLY NEUROMUSCULAR STIMULATOR.

The company's portfolio includes Class I and Class II devices listed in the FDA 510(k) registry, and it is based in the US.

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

Catalogue9

Newest first, rows 1-9 of 9

  • Suture-Aid Booties Ref K832441

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Omed Silicone Instrument Covers Ref K810883

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Omed Dispos. Instrument Guards Ref K842603

    Active Regimes: 510(k) Registry: 510(k) Class:—
  • Omed Fabric Instrument Covers Ref K810269

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Omed Fabric Instrument Covers-Radiopaq Ref K821334

    Active Regimes: 510(k) Registry: 510(k) Class:—
  • Comply Neuromuscular Stimulator Ref K822284

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Omed Silicone Loops Ref K810260

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Omed Ident-I-Band Ref K830484

    Active Regimes: 510(k) Registry: 510(k) Class:—
  • Omed Disposable Bulldog Ref K813499

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

Frequently asked questions

How many devices does Omega-Med Intl., Inc. have in the registry?

The registry currently lists 9 devices for Omega-Med Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Omega-Med Intl., Inc.'s devices?

Among its 9 most recently registered devices, Omega-Med Intl., Inc. has devices listed in FDA 510(k) (9 devices).

What risk classes do Omega-Med Intl., Inc.'s devices fall under?

Among its 9 most recently registered devices, the classes recorded for Omega-Med Intl., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Omega-Med Intl., Inc. in the registry?

The most recently registered devices listed for Omega-Med Intl., Inc. include SUTURE-AID BOOTIES, OMED SILICONE INSTRUMENT COVERS, OMED DISPOS. INSTRUMENT GUARDS and OMED FABRIC INSTRUMENT COVERS.

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