Johnson & Johnson MedTech: FDA 510(k) clearances across all its applicant names

FDA lists 2,309 510(k) clearances, 56 PMA and 3 De Novo decisions across the 78 applicant names Caduvo groups under Johnson & Johnson MedTech, first 1976, latest 2026. Median 510(k) review time across these names: 84 days. Since 2017 the median was 108 days, against 119 days for all cleared 510(k)s in the same product codes. Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

510(k) clearances per year

The 78 FDA applicant names in this group

Review time against the same product codes

Since 2017, 510(k)s cleared under these names took a median 108 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.

Top product codes

Plus 361 more product codes.

Review panels

• Orthopedic (1,269)
• General and Plastic Surgery (458)
• Cardiovascular (162)
• Dental (98)
• Gastroenterology and Urology (85)
• Ophthalmic (78)
• General Hospital (63)
• Ear, Nose and Throat (47)
• Obstetrics and Gynecology (38)
• Neurology (36)
• Physical Medicine (8)
• Anesthesiology (5)
• Radiology (5)

Most recent Johnson & Johnson MedTech 510(k) clearances

2,299 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

1,589 product recalls in 466 recall events under these names; 182 initiated in the last five years.

Recalling firms are matched to the applicant names above by name only, so recalls filed under other names are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

How this group is built

Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

DePuy (1998), Synthes (2012), Ethicon, Biosense Webster, Mentor (2009), Acclarent (2010), Auris Health (2019), Abiomed (2022), Shockwave Medical (2024) and Abbott Medical Optics (2017, now J&J Surgical Vision). CORDIS WEBSTER (1995–1999), a predecessor of Biosense Webster, is left out because the Cordis name history is mixed. Includes filings made before each acquisition. Left out: Cordis (sold to Cardinal Health in 2015), Codman neurosurgery (sold to Integra in 2017), LifeScan (sold 2018), Advanced Sterilization Products (sold 2019), Ortho Clinical Diagnostics (sold 2014), consumer names (now Kenvue). MEDOS INTERNATIONAL SARL left out because it filed for both DePuy Synthes and Codman (divested).

Sources

• https://en.wikipedia.org/wiki/Johnson_%26_Johnson
• https://en.wikipedia.org/wiki/DePuy_Synthes
• https://en.wikipedia.org/wiki/Ethicon_Inc.
• https://en.wikipedia.org/wiki/Abiomed
• https://shockwavemedical.com/news/johnson-johnson-completes-acquisition-of-shockwave-medical/
• https://en.wikipedia.org/wiki/Auris_Health

Frequently asked questions

How many FDA 510(k) clearances are listed across Johnson & Johnson MedTech's applicant names?

FDA lists 2,309 510(k) clearances, 56 PMA and 3 De Novo decisions across the 78 applicant names Caduvo groups under Johnson & Johnson MedTech, first 1976, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Johnson & Johnson MedTech file under?

The names with the most 510(k) clearances in this group are Synthes (Usa) (407); Depuy, Inc. (303); DePuy Orthopaedics, Inc. (210); ETHICON, Inc. (208); Ethicon Endo-Surgery, Inc. (183). The full list of 78 names is on this page.

How long does FDA take to clear Johnson & Johnson MedTech 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 84 days. Since 2017 the median was 108 days, against 119 days for all cleared 510(k)s in the same product codes.

Does the Johnson & Johnson MedTech count include acquired companies?

Yes. A group includes filings an acquired business made under its own name, including before the acquisition. Businesses that were sold are left out, and names whose ownership is unclear are not included. FDA does not group applicants; the sources for each grouping are listed on this page.

Next steps

• See all 2,309 Johnson & Johnson MedTech clearances with predicates and recalls
• Run predicate analysis for product code HRS, Johnson & Johnson MedTech's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls). Applicant names are matched exactly, with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this grouping or data.

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