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Orion Life Systems, Inc.

United StatesFDA applicant, unverified

Devices
33

What Orion Life Systems, Inc. makes

Orion Life Systems, Inc. manufactures single-use medical supplies for irrigation, enteral feeding, and wound care, including pre-filled syringes with sterile water and saline solutions, suction catheters, irrigation trays, and replacement gastrostomy tubes. Their portfolio also covers sterile towels, flush irrigation sets, and accessories like Y-adaptors and leg bags for medical procedures.

The company’s devices are classified under FDA categories Class I, Class II, and Unclassified (U), with many authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.

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

Catalogue33

Newest first, rows 1-33 of 33

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  • Pre-Filled Sysringe W/Sterile Water Ref K943829

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

  • Dual Port Enteral Y-Adaptor Ref K923168

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

  • External Leg Bag Ref K901219

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

  • Pre-Filled Syringe W/Sterile 0.9% Sodium Chloride Solution Ref K943830

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

  • Bulb Irrigation Tray Ref K900736

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

  • Suction Catheter, Sterile Ref K902814

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

  • Shave Prep Tray Ref K902813

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

  • Orion Sterile Or Towels Ref K903117

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

  • Sterile .9% Sodium Chloride For Irration Ref K943832

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

  • Flushing Irrigation Set Ref K923497

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

  • Orion Life Systems Replacement Gastrostomy Tube Ref K904801

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

  • Sterile Water For Irrigation Ref K943828

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

  • Peri-Bottle Ref K902830

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

  • Urinary Care Supplies Ref K923496

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

  • Pre-Filled 10cc Inflation Syringe W/Sterile Water Ref K943836

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

  • Suture Removal Tray Ref K902828

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

  • Pre-Filled 30cc Inflation Syringe W/Sterile Water Ref K943831

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

  • Foley Catheter Insertion Tray (30cc) Ref K901180

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

  • Trachael Suction Set Ref K896887

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

  • Sterile I.V. Start Kit Ref K902810

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

  • Sterile Water For Irration Ref K943833

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

  • Wound Treatment Kit Ref K901109

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

  • Catheter Care Tray Ref K901181

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

  • Urethral Catheter Tray (Pvc) Ref K901183

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

  • Tracheostomy Care Tray Ref K923156

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

  • Pre-Filled Syringe W/Sterile .25% Acetc Acid Ref K943835

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

  • Enema Bag Set Ref K901182

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

  • Enema Bucket Set Ref K901179

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

  • Foley Catheter Insertion Tray (10cc) Ref K901185

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

  • Urethral Catheter Tray (Latex) Ref K901184

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

  • Routine Dressing Tray Ref K902811

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

  • Sterile .9% Sodium Chloride Solution Ref K943834

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

  • Piston Irrigation Tray Ref K900737

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

Rows 1-33 of 33

Frequently asked questions

How many devices does Orion Life Systems, Inc. have in the registry?

The registry currently lists 33 devices for Orion Life Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Orion Life Systems, Inc.'s devices?

Among its 33 most recently registered devices, Orion Life Systems, Inc. has devices listed in FDA 510(k) (33 devices).

What risk classes do Orion Life Systems, Inc.'s devices fall under?

Among its 33 most recently registered devices, the classes recorded for Orion Life Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Orion Life Systems, Inc. in the registry?

The most recently registered devices listed for Orion Life Systems, Inc. include PRE-FILLED SYSRINGE W/STERILE WATER, DUAL PORT ENTERAL Y-ADAPTOR, EXTERNAL LEG BAG and PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION.

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