Stryker Corp.: FDA filings under this applicant name

FDA lists 352 510(k) clearances under the applicant name “Stryker Corp.” (first 1976, latest 2026), plus 2 PMA decisions, across 109 product codes in 11 review panels. Median 510(k) review time under this name: 98 days. Since 2017 the median was 90 days, against 108 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 Corp. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.

Top product codes

Plus 99 more product codes.

Review panels

• Orthopedic (177)
• General and Plastic Surgery (60)
• Neurology (40)
• General Hospital (23)
• Dental (19)
• Ear, Nose and Throat (14)
• Cardiovascular (8)
• Physical Medicine (4)
• Obstetrics and Gynecology (3)
• Gastroenterology and Urology (2)
• Radiology (2)

Most recent Stryker Corp. 510(k) clearances

342 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

192 product recalls in 59 recall events; 112 initiated in the last five years. Most recent: 2026-07-01.

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.

SEC filings

STRYKER CORP (SYK): EDGAR filings, CIK 310764. An SEC registrant with the same name, matched by name only.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Stryker Corp. (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 Endoscopy (102 510(k)s)
• Stryker Spine (75 510(k)s)
• Stryker Instruments (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 Corp.?

FDA lists 352 510(k) clearances under the applicant name “Stryker Corp.” (first 1976, latest 2026), plus 2 PMA decisions, across 109 product codes in 11 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 Corp.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Stryker Corp. is 98 days. Since 2017: 90 days, versus 108 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Stryker Corp.?

The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 25); GCJ (Laparoscope, General & Plastic Surgery, 20); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 17).

Next steps

• See all 352 Stryker Corp. clearances with predicates and recalls
• Run predicate analysis for product code HRS, Stryker Corp.'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.

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