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Hydrocision, Inc.

United StatesFDA applicant, unverified FDA FEI 3003018854

Hydrocision, Inc. is a medical device manufacturer, with 46 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) and 2 FDA recalls as of 13 Nov 2026.

Devices
46
Registrations
FDA
FDA recalls
2

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 34
  • FDA 510(k) 12

A device listed in two registries counts in both.

Device classes
  • FDA Class II 45
FDA recalls
Identifiers
  • FDA FEI 3003018854
  • DUNS 834612764

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

Catalogue46

Newest first, rows 1-46 of 46

Search and filter all 46 devices
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  • TenJet® 76000

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

  • SpineJet® 56986

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

  • SpineJet® 55500

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

  • SpineJet® 56987

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

  • SpineJet® 59961

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

  • SpineJet® 58662

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

  • SpineJet® 57162

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

  • SpineJet® 52005

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

  • TenJet® 76700

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

  • TenJet® 76400

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

  • SpineJet® 56000

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

  • SpineJet® 59662

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

  • SpineJet® 56110

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

  • SpineJet® 51739

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

  • QuickKart Procedure Cart 50300

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

  • Allograft 53150

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

  • Cannula 57165

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

  • SpineJet® 58663

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

  • SpineJet® 57662

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

  • HydroCision Console 52700

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

  • SpineJet® 58163

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

  • Knob 51705

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

  • Allograft-ALT 53150 ALT

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

  • SpineJet® 57667

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

  • SpineJet® 52320

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

  • Trephine 51711

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

  • SpineJet® 57167

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

  • SpineJet® 59971

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

  • SpineJet® 56971

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

  • SpineJet® 58162

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

  • HydroCision Console 82700

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

  • SpineJet® 51786

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

  • SpineJet® 51740

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

  • SpineJet® PerResector-China Version 56000

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

  • Hydrocision Arthrojet System With Cautery And Burr Ref K002764

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

  • Modification To Hydrocision Debridement System Ref K011612

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

  • Hydrocision Debdridement System Ref K991383

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

  • Hydrocision Arthojet System With Cautery And Turboburr Ref K020688

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

  • Hydrocision General Surgery Fluidjet System Ref K021813

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

  • Hydrocision Arthrojet System With Cautery, Turboburr And Curette, Models 51300, 51310 Ref K032529

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

  • Hydrocision Arthrojet System Ref K982266

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

  • Arthrojet Xt Ref K041233

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

  • HydroCision TenJet Device Ref K190804

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

  • Hydrocision Arthrojet System With Cautery Ref K993009

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

  • HydroCision SpineJet System Ref K200729

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

  • SpineSite Endoscope System Ref K241990

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

Rows 1-46 of 46

Company details

FDA FEI number
3003018854
DUNS number
834612764
Address
267 Boston Road, BILLERICA, MA, 01862

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

  • 2006

    • 7 Sep 2006 Z-0123-2007 Unclassified (pre-2012) Terminated Distal tip may become detached from the device Distribution: Nationwide. Submission number: K032529
    • 7 Sep 2006 Z-0124-2007 Unclassified (pre-2012) Terminated Distal tip may become detached from the device Distribution: Nationwide. Submission number: K032529

Frequently asked questions

How many devices does HYDROCISION, INC. have in the registry?

The registry currently lists 46 devices for HYDROCISION, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list HYDROCISION, INC.'s devices?

Among its 46 most recently registered devices, HYDROCISION, INC. has devices listed in FDA 510(k) (12 devices) and FDA GUDID (34 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do HYDROCISION, INC.'s devices fall under?

Among its 46 most recently registered devices, the classes recorded for HYDROCISION, INC.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for HYDROCISION, INC.?

FDA recall records list 2 recalls initiated by HYDROCISION, INC., the most recent initiated on 7 Sep 2006. 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 HYDROCISION, INC. in the registry?

The most recently registered devices listed for HYDROCISION, INC. include TenJet® 76000, SpineJet® 56986, SpineJet® 55500 and SpineJet® 56987.

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