Smith & Nephew, Inc.: FDA filings under this applicant name

FDA lists 547 510(k) clearances under the applicant name “Smith & Nephew, Inc.” (first 1980, latest 2026), plus 5 PMA and 1 De Novo decisions, across 106 product codes in 12 review panels. Median 510(k) review time under this name: 80 days. Since 2017 the median was 86 days, against 115 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 Smith+Nephew, 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 Smith & Nephew, Inc. took a median 86 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.

Top product codes

Plus 96 more product codes.

Review panels

• Orthopedic (397)
• General and Plastic Surgery (83)
• General Hospital (14)
• Neurology (14)
• Obstetrics and Gynecology (12)
• Gastroenterology and Urology (7)
• Ear, Nose and Throat (5)
• Physical Medicine (5)
• Radiology (5)
• Dental (4)
• Cardiovascular (3)
• Ophthalmic (1)

Most recent Smith & Nephew, Inc. 510(k) clearances

537 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

448 product recalls in 135 recall events; 33 initiated in the last five years. Most recent: 2026-03-16.

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 Smith & Nephew, Inc. is the lead sponsor of 76 device studies on ClinicalTrials.gov (18 active or recruiting). Most recent:

• NCT07025304: Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China (Recruiting, started 2025-07-02)
• NCT06916728: A Post Approval Multicenter 10 Year Follow-up Observational Trial of Marketed Product - MP01 vs. Surgical Standard of Care (SSOC) Used for the Treatment of Joint Surface Lesions of the Knee (Enrolling by invitation, started 2025-05-05)
• NCT06831448: Human Participant Study of a Prototype Multilayer Foam Dressing on Intact Skin. (Completed, started 2025-01-27)
• NCT06700850: Human Participant Study of Prototype Non-medicated Multilayer Foam Dressings on Intact Skin (Completed, started 2024-10-28)
• NCT06564636: A Multi-Centre Study in Patients Undergoing Total Hip Arthroplasty With the Smith+Nephew CATALYSTEM™ Primary Hip System (Active not recruiting, started 2024-09-26)

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Smith & Nephew, Inc. (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.

• Smith & Nephew Richards, Inc. (87 510(k)s)
• Smith & Nephew United, Inc. (34 510(k)s)
• Smith & Nephew Dyonics, Inc. (22 510(k)s)
• Smith & Nephew Medical Limited (20 510(k)s)
• Smith & Nephew Endoscopy, Inc. (18 510(k)s)
• Smith and Nephew Donjoy, Inc. (15 510(k)s)
• Smith & Nephew Medical, Ltd. (12 510(k)s)
• Smith River Biologicals (12 510(k)s)
• Smith & Nephew Inc., Endoscopy Div. (10 510(k)s)
• Smith & Nephew, Inc., Orthopaedic Div. (10 510(k)s)
• Smith & Nephew Perry (10 510(k)s)
• Smith & Nephew, Mpl Division (9 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Smith & Nephew, Inc.?

FDA lists 547 510(k) clearances under the applicant name “Smith & Nephew, Inc.” (first 1980, latest 2026), plus 5 PMA and 1 De Novo decisions, across 106 product codes in 12 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 Smith & Nephew, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Smith & Nephew, Inc. is 80 days. Since 2017: 86 days, versus 115 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Smith & Nephew, Inc.?

The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 49); HRS (Plate, Fixation, Bone, 37); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 32).

Next steps

• See all 547 Smith & Nephew, Inc. clearances with predicates and recalls
• Run predicate analysis for product code JWH, Smith & Nephew, Inc.'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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