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Ultracell Medical Technologies, Inc.

United StatesFDA applicant, unverified

Devices
24
FDA recalls
13

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Ultracell Medical Technologies, Inc. makes

Ultracell Medical Technologies, Inc. manufactures single-use medical devices for nasal, ear, and ophthalmic procedures, including epistaxis catheters, nasal packing, suction sponges, ear wicks, and surgical accessories like retractors and instrument wipes. Their portfolio also includes nasal splints and specialized sponges for neurosurgical applications.

The company’s devices are classified under FDA categories Class I and Class II, with relevant products listed via the 510(k) pathway. These products are intended for use in the United States, where the manufacturer is based.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue24

Newest first, rows 1-24 of 24

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  • Anterior/Posterior Epistaxis Catheter Ref K945556

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

  • Ultracell Nasal Packing Ref K920358

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

  • Ultracell Instrument Wipe Ref K920353

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

  • Nasal Splint Ref K945555

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

  • Ophthalmic Sponges Ref K920354 Open recall

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

  • Ultracell Suction Sponge Ref K972633

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

  • Epistaxis Balloon Catheter With Packing Ref K945554

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

  • Surgical Spears Ref K923922

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

  • Ultracell Ear Wick Ref K920357 Open recall

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

  • Ultracell Neuro Sponges Ref K970328

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

  • Ultracell Retractor Covers Ref K950659

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

  • Ultracell Neuro Sponges Ref K973083

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

  • Surgical Sponges Ref K920356

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

  • Ultracell Orthopedic Sponges Ref K950372

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

  • Specialty Sponges Ref K920355

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

  • Ultracell Suction Sponge Ref K972635

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

  • Ultracell Packing With Sleeve Ref K973085

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

  • Ultracell Orthopedic Sponges Ref K950373

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

  • Ultracell Neuro Sponges Ref K950647

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

  • Ultracell Orthopedic Sponges Ref K950370

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

  • Ultracell Suction Sponge Ref K972634

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

  • Ultracell Absorbent Stick Ref K012196

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

  • Visual Endoscopic Non-Alcohol Ultracell Sponge (Venus) Ref K973558

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

  • Nasal-Sinus Packing Ref K924542

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

Rows 1-24 of 24

FDA recalls13

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 13 recalls initiated by Ultracell Medical Technologies, Inc., initiated on 2003-01-08. By recorded status: 13 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 13 recalls.

  • 2003

    • 8 Jan 2003 Z-0478-03 Unclassified (pre-2012) Terminated Sterility of the device is compromised Distribution: Nationwide Submission number: K920358
    • 8 Jan 2003 Z-0479-03 Unclassified (pre-2012) Terminated Sterility of the device is compromised Distribution: Nationwide
    • 8 Jan 2003 Z-0480-03 Unclassified (pre-2012) Terminated Sterility of the device is compromised Distribution: Nationwide Submission number: K920357
    • 8 Jan 2003 Z-0481-03 Unclassified (pre-2012) Terminated Sterility of the device is compromised Distribution: Nationwide Submission number: K920357
    • 8 Jan 2003 Z-0482-03 Unclassified (pre-2012) Terminated Sterility of the device is compromised Distribution: Nationwide Submission number: K920357
    • 8 Jan 2003 Z-0483-03 Unclassified (pre-2012) Terminated Sterility of the device is compromised Distribution: Nationwide Submission number: K920357
    • 8 Jan 2003 Z-0484-03 Unclassified (pre-2012) Terminated Sterility of the device is compromised Distribution: Nationwide
    • 8 Jan 2003 Z-0485-03 Unclassified (pre-2012) Terminated Sterility of the device is compromised Distribution: Nationwide Submission number: K920357
    • 8 Jan 2003 Z-0486-03 Unclassified (pre-2012) Terminated Sterility of the device is compromised Distribution: Nationwide Submission number: K920358
    • 8 Jan 2003 Z-0487-03 Unclassified (pre-2012) Terminated Sterility of the device is compromised Distribution: Nationwide Submission number: K923922
Show all 13 recalls

  • 2003

    • 8 Jan 2003 Z-0488-03 Unclassified (pre-2012) Terminated Sterility of the device is compromised Distribution: Nationwide Submission number: K923922
    • 8 Jan 2003 Z-0489-03 Unclassified (pre-2012) Terminated Sterility of the device is compromised Distribution: Nationwide Submission number: K923922
    • 8 Jan 2003 Z-0490-03 Unclassified (pre-2012) Terminated Sterility of the device is compromised Distribution: Nationwide Submission number: K920358

Frequently asked questions

How many devices does Ultracell Medical Technologies, Inc. have in the registry?

The registry currently lists 24 devices for Ultracell Medical Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ultracell Medical Technologies, Inc.'s devices?

Among its 24 most recently registered devices, Ultracell Medical Technologies, Inc. has devices listed in FDA 510(k) (24 devices).

What risk classes do Ultracell Medical Technologies, Inc.'s devices fall under?

Among its 24 most recently registered devices, the classes recorded for Ultracell Medical Technologies, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Ultracell Medical Technologies, Inc.?

FDA recall records list 13 recalls initiated by Ultracell Medical Technologies, Inc., the most recent initiated on 8 Jan 2003. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Ultracell Medical Technologies, Inc. in the registry?

The most recently registered devices listed for Ultracell Medical Technologies, Inc. include ANTERIOR/POSTERIOR EPISTAXIS CATHETER, ULTRACELL NASAL PACKING, ULTRACELL INSTRUMENT WIPE and NASAL SPLINT.

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