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Aspen Laboratories, Inc.

United StatesFDA applicant, unverified

Devices
55

What Aspen Laboratories, Inc. makes

Aspen Laboratories, Inc. manufactures fiber optic adapters and light guides for medical illumination, including headlights and standalone guides, as well as tourniquets, cannula sets, ECG electrodes, and connectors for medical devices. Their product line also includes single-use ball electrodes and a TMJ cannula set for orthopedic and dental procedures.

The company’s devices are classified under FDA categories Class I and Class II, with submissions recorded in the FDA’s 510(k) registry. Their products are listed in the United States under U.S. regulatory requirements.

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

Catalogue55

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  • Fiber Optic Adapter #60-0892 Ref K802774

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

  • Fiber Optic Light Guide CAT#60-0768 Ref K802767

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

  • Fiber Optic Headlight #60-0766766 Ref K802770

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

  • Fiber Optic ADAPTERS#60-0893 Ref K810300

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

  • A.T.S. 1500 Tourniquet Ref K870784

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

  • Single Use Ball Electrode Ref K780976

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

  • Tmj Cannula Set Ref K871648

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

  • Adult Ecg Electrode #60-0724 Ref K810103

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

  • A.C.L. Guide Kit Ref K862564

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

  • Hand-Trol Connector Extender Ref K781429

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

  • Banana Cuff Ref K841558

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

  • Fiber Optic Light Guide #60-0767 Ref K802773

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

  • Electrosurgical Flexible Electrode In-Line Suction Coagulator Ref K944012

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

  • Rgb Camera System Ref K872661

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

  • System 7500 Abc Electrosurgical Unit Ref K981220

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

  • Mf-450 Electrosurgical Unit 60-5500-001 Ref K896839

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

  • Electrode, Flexible Suction Coagulator Ref K831290

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

  • Safety Holster, Single-Use Ref K790770

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

  • Single Use Lee Electrode Ref K913213

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

  • Sheath, Electrosurgical Pencil Ref K963088

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

  • Bistat Electrosurgical Unit 60-5400-001 Ref K896838

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

  • Excalibur Plus Electrosurgical Unit Ref K953007

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

  • Universal Cannula System Ref K863590

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

  • Magnetic Retriever Ref K854281

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

  • Single Use Active Electrode Handle Ref K780978

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

  • Mf 360B Electrosurgical Unit Ref K823923

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

  • Meniscal Stitching Kit Ref K853801

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

  • System 6500 Abc Electrosurgical Unit Ref K955834

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

  • Fiber Optic ADAPTERS#60-0891 Ref K810299

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

  • Mason Equipment Organizer & Aspen Ref K843801

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

  • Electrosurgical Power Generators Ref K771007

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

  • Ats 500 Tourniquet Ref K853802

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

  • Fiber Optic Adapter #60-0894 Ref K802772

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

  • Beamer Plus Ref K953081

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

  • Reusable Hand-Trol Ref K800597

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

  • Single Use Needle Electrode Ref K780975

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

  • Fiber Optic Adapter #60-0897 Ref K802768

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

  • Single And Dual Tourniquet Cuff Ref K860463

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

  • Fiber Optic Adapter CAT#60-0898 Ref K802766

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

  • Smokievac Electrosurgical Pencil Ref K946104

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

  • Fiber Optic Headlight #60-0765 Ref K802769

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

  • Fiber Optic Adapter #60-895 Ref K802771

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

  • Electrosurgical Unit-Mf 380 #60-1700 Ref K831291

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

  • Tourniquet Ref K813231

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

  • Electrosurgical Dispersive Plate Ref K760675

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

  • 4000 Etm Ref K960296

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

  • Single Use Arthroscopy Electrode Ref K852355

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

  • Excalibur Electrosurgical Unit Ref K924960

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

  • Single Use Blade Electrode Ref K780977

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

  • Water Resistant Footswitch W/Cable Ref K810101

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

Rows 1-50 of 55

Showing 1-50 of 55

Frequently asked questions

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

The registry currently lists 55 devices for Aspen Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Aspen Laboratories, Inc.'s devices?

Among its 50 most recently registered devices, Aspen Laboratories, Inc. has devices listed in FDA 510(k) (50 devices).

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

Among its 50 most recently registered devices, the classes recorded for Aspen Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Aspen Laboratories, Inc. in the registry?

The most recently registered devices listed for Aspen Laboratories, Inc. include FIBER OPTIC ADAPTER #60-0892, FIBER OPTIC LIGHT GUIDE CAT#60-0768, FIBER OPTIC HEADLIGHT #60-0766766 and FIBER OPTIC ADAPTERS#60-0893.

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