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Stryker Instruments

Active in EUDAMED
Also registered as Stryker Instruments, Instruments Div., Styker Instruments

United Statesfrom SRN EUDAMED FDA SRN US-MF-000025219 FEI 3015967359

Stryker Instruments is a medical device manufacturer based in the United States, with 148 devices listed in FDA 510(k), EUDAMED and FDA GUDID (FDA Class II and I; EU Class IIa and I) and 6 FDA recalls as of 12 Nov 2026.

Devices
148
Registrations
EUDAMEDFDA
FDA recalls
61 ongoing

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • FDA 510(k) 83
  • EUDAMED 66
  • FDA GUDID 23

A device listed in two registries counts in both.

Device classes
  • FDA Class II 77
  • EU Class IIa 41
  • EU Class I 22
  • FDA Class I 4
  • EU Class IIb 2
  • FDA Unclassified 2
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000025219
  • FDA FEI 3015967359

At a glance

Counted by deviCERTS from registry records

EU certificates

3 of 5 in force. 1 certificate has expired.

See certificates

Market reach

European Union
EUDAMED actor, 5 certificates
United States
FDA FEI, FDA recalls
Authorised rep.
Stryker European Operations LimitedIE

What Stryker Instruments makes

Stryker Instruments manufactures single-use cranial burs, including J-Notch Burs, and reusable instrument trays for surgical applications. Their portfolio also includes ultrasonic surgical system generators, such as the TPX and TPS Burs, along with ancillary tools like torque wrenches and irrigation systems. The company provides consolidated operating room equipment, including the CORE System, for surgical environments.

The company’s devices are classified under FDA categories Class I, Class II, Class IIa, and Class U, with corresponding regulatory records in the EU’s eudamed database and FDA’s 510(k) clearance registry. The manufacturer is based in the United States.

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

Catalogue148

Newest first, rows 1-50 of 148

Search and filter all 148 devices
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  • Neptune Ref 0711-002-000EF

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0703-002-000ENI

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0711-002-000SV

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • SmartLife Ref 7222-110-000

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Neptune Ref 0711-002-000FI

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0703-002-000ES

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0703-002-000ENF

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0711-002-000NL

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Nasopore Ref 5400-030-008ITL

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Nasopore Ref 5400-030-004ITL

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Neptune Ref 0703-002-000FI

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • SmartLife Ref 7126-110-000

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Neptune Ref 0703-002-000NO

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Nasopore Ref 5400-020-108ITL

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Neptune Ref 0703-002-000FR

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0711-002-000DA

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Nasopore Ref 5400-020-004ITL

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Neptune Ref 0703-246-004

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Neptune Ref 0703-246-005

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Otopore Ref 5400-020-000ITL

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Neptune Ref 0711-002-000IT

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0703-002-000SV

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0711-002-000EI

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0711-002-000NO

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0703-002-000PL

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0711-002-000EG

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0703-002-000NL

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Otopore Ref 5400-020-100ITL

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Otopore Ref 5400-010-000ITL

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Nasopore Ref 5400-020-008ITL

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Neptune Ref 0703-002-000PT

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0711-002-000PL

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0703-002-000ZH

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0703-002-000ENG

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0711-002-000DE

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0711-002-000ES

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0711-002-000PT

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0703-002-000DE

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0703-002-000IT

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neptune Ref 0703-002-000DA

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Nasopore Ref 5400-010-004ITL

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Naspore Ref 5400-010-008ITL

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Neptune Ref 0711-002-000FR

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Hydro Irrigation System Ref K261544

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

  • Sonopet iQ Series III Console (5700-050-000) Ref K262244

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

  • Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100) Ref K261959

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

  • PROstep Ref 7200-015-043

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Bpx Ref 7900-037-000

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Power Tool Attachments Ref 7200-015-020

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Bpx Ref 7900-013-000

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

Rows 1-50 of 148

Showing 1-50 of 148

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000025219
FDA FEI number
3015967359
EUDAMED status
Active
EUDAMED registered name
Stryker Instruments
Registered address
1941, Stryker Way, 49002, Portage, United States
Phone
+1 8002533210
PRRC contact
Caitlyn Covault(public in EUDAMED)

EUDAMED certificates5

5 certificates3 valid, 1 expired, 1 withdrawn or suspendedMDR 5next expiry 15 Dec 2029

EUDAMED certificates (5)

TÜV Rheinland LGA Products GmbH 0197 4 certificates

  • IZ 2247538-2 Active

    Technical documentation EU MDR

    Issued
    12 May 2026
    Expires
    11 May 2031
  • HZ 2247538-1 Active Supplemented

    Quality management system EU MDR

    Issued
    3 Sep 2026
    Expires
    27 Feb 2031
    Reason
    Add device or group
  • IZ 2247538-1 Active

    Technical documentation EU MDR

    Issued
    16 Dec 2024
    Expires
    15 Dec 2029
  • HZ 2247538-1 Expired

    Quality management system EU MDR

    Issued
    28 Nov 2025
    Expires
    27 Feb 2026
    Reason
    Mnf data change

GMED SAS 0459 1 certificate

  • 40551 Withdrawn

    Quality management system EU MDR

    Issued
    10 Jun 2026
    Expires
    10 Sep 2028
    Reason
    Transferred to other nb

FDA recalls6

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

FDA recall records list 1 recall initiated by Stryker Instruments, initiated on 2022-06-24. By recorded status: 1 ongoing. The reasons filed fall into these groups: mechanical integrity. 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.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 1
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

5 initiated before 2017

  • 2022

    • 24 Jun 2022 Z-1478-2022 Class II Ongoing There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures. Distribution: Worldwide distribution - US Nationwide distribution in the states of Arizona, California, Florida, Georgia, Iowa,…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of Arizona, California, Florida, Georgia, Iowa, Michigan, Missouri, New Mexico, North Carolina, Ohio, Texas, Virginia and the countries of Canada, Netherlands, and Thailand.
      Submission number: K143320

  • 2004

    • 14 Jul 2004 Z-0020-05 Unclassified (pre-2012) Terminated The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system. Distribution: United States. Submission number: K022365
    • 14 Jul 2004 Z-0021-05 Unclassified (pre-2012) Terminated The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system. Distribution: United States. Submission number: K022365

  • 2003

    • 12 Nov 2003 Z-0171-04 Unclassified (pre-2012) Terminated Product sterility may have been compromised by an inadequate package seal. Distribution: United States, France and United Kingdom.
    • 1 Jun 2003 Z-0921-03 Unclassified (pre-2012) Terminated Non-sterilized product sold as sterile. Distribution: United States, Canada, Italy, Japan and United Kingdom Submission number: K912190

  • 2002

    • 3 Dec 2002 Z-0524-03 Unclassified (pre-2012) Terminated Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R. Distribution: United States Submission numbers: K990037, K012991

Frequently asked questions

How many devices does Stryker Instruments have in the registry?

The registry currently lists 148 devices for Stryker Instruments. Devices recorded under merged duplicate company entries are counted once.

Which registries list Stryker Instruments's devices?

Among its 50 most recently registered devices, Stryker Instruments has devices listed in EUDAMED (47 devices), FDA 510(k) (3 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Stryker Instruments's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Stryker Instruments's devices are Class I, Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Stryker Instruments?

FDA recall records list 6 recalls initiated by Stryker Instruments, the most recent initiated on 24 Jun 2022. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Stryker Instruments?

EUDAMED lists 5 certificates for Stryker Instruments (technical documentation; quality management system) under MDR. 2 are recorded with the status issued. The most recent was issued on 3 Sep 2026.

What are the newest devices from Stryker Instruments in the registry?

The most recently registered devices listed for Stryker Instruments include Neptune, SmartLife, Nasopore and Otopore.

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