Stryker Instruments: FDA filings under this applicant name

FDA lists 75 510(k) clearances under the applicant name “Stryker Instruments” (first 1994, latest 2026), across 38 product codes in 7 review panels. Median 510(k) review time under this name: 88 days. Since 2017 the median was 91 days, against 123 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under Stryker, based on public ownership records.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Stryker Instruments took a median 91 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.

Top product codes

Plus 28 more product codes.

Review panels

• Neurology (19)
• General and Plastic Surgery (16)
• General Hospital (15)
• Dental (10)
• Orthopedic (10)
• Ear, Nose and Throat (3)
• Cardiovascular (2)

Most recent Stryker Instruments 510(k) clearances

65 earlier clearances. See the full list in Caduvo.

Recalls

1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-06-24.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Stryker Instruments is the lead sponsor of 3 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:

• NCT04154605: ClariFix Rhinitis RCT (Completed, started 2019-11-05)
• NCT03072927: MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study (Recruiting, started 2017-03-10)
• NCT00829803: A Study to Assess Indices of SNAP vs VISTA on Surgical Patients Undergoing General Anesthesia (Completed, started 2009-02)

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Stryker Instruments (a text match, not an official crosswalk):

• A4220 — Refill kit for implantable infusion pump (via FRN)
• E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
• E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Stryker Corp. (352 510(k)s)
• Stryker Endoscopy (102 510(k)s)
• Stryker Spine (75 510(k)s)
• Stryker Sustainability Solutions (34 510(k)s)
• Stryker Neurovascular (33 510(k)s)
• Stryker Trauma AG (25 510(k)s)
• Stryker Orthopaedics (24 510(k)s)
• Stryker Leibinger GmbH & Co KG (22 510(k)s)
• Stryker Medical (14 510(k)s)
• Stryker Leibinger (13 510(k)s)
• Stryker Trauma GmbH (7 510(k)s)
• Stryker Corporate (6 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Stryker Instruments?

FDA lists 75 510(k) clearances under the applicant name “Stryker Instruments” (first 1994, latest 2026), across 38 product codes in 7 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Stryker Instruments?

The median time from FDA receipt to decision across 510(k)s cleared under the name Stryker Instruments is 88 days. Since 2017: 91 days, versus 123 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Stryker Instruments?

The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 7); HAW (Neurological Stereotaxic Instrument, 6); FYA (Gown, Surgical, 5).

Next steps

• See all 75 Stryker Instruments clearances with predicates and recalls
• Run predicate analysis for product code GEI, Stryker Instruments's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

All FDA device companies · FDA product code lookup