Johnson & Johnson Professionals, Inc.: FDA filings under this applicant name

FDA lists 206 510(k) clearances under the applicant name “Johnson & Johnson Professionals, Inc.” (first 1976, latest 2000), across 85 product codes in 12 review panels. Median 510(k) review time under this name: 59 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Top product codes

Plus 75 more product codes.

Review panels

• Orthopedic (60)
• Dental (50)
• General and Plastic Surgery (33)
• Neurology (14)
• Cardiovascular (9)
• Gastroenterology and Urology (9)
• General Hospital (9)
• Radiology (8)
• Obstetrics and Gynecology (6)
• Physical Medicine (4)
• Clinical Chemistry (1)
• Hematology (1)

Most recent Johnson & Johnson Professionals, Inc. 510(k) clearances

196 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Johnson & Johnson Professionals, Inc..

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.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Johnson & Johnson Professionals, Inc. (a text match, not an official crosswalk):

• C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
• C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)

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.

• Johnson & Johnson Medical, Inc. (53 510(k)s)
• Johnson & Johnson Clinical Diagnostics, Inc. (33 510(k)s)
• Johnson & Johnson Orthopaedics, Inc. (22 510(k)s)
• Johnson & Johnson (14 510(k)s)
• Johnson & Johnson Vision Care, Inc. (12 510(k)s)
• Johnson & Johnson International (10 510(k)s)
• Johnson & Johnson Consumer Products, Inc. (8 510(k)s)
• Johnson & Johnson Medical, Div. of Ethicon, Inc. (5 510(k)s)
• Johnson & Johnson Surgical Vision, Inc. (4 510(k)s)
• Johnson & Johnson Patient Care, Inc. (4 510(k)s)
• Johnson & Johnson Medical, Ltd. (3 510(k)s)
• Johnson & Johnson Consumer, Inc. (2 510(k)s)

Frequently asked questions

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

FDA lists 206 510(k) clearances under the applicant name “Johnson & Johnson Professionals, Inc.” (first 1976, latest 2000), across 85 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 Johnson & Johnson Professionals, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Johnson & Johnson Professionals, Inc. is 59 days.

Which FDA product codes appear under Johnson & Johnson Professionals, Inc.?

The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 15); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 14); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 9).

Next steps

• See all 206 Johnson & Johnson Professionals, Inc. clearances with predicates and recalls
• Run predicate analysis for product code EBF, Johnson & Johnson Professionals, 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 (spelling variants such as punctuation and legal suffixes combined); 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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