510(k) Report

FDA applicant

Johnson & Johnson Professionals, Inc.

Raynham, MA206 decisions1976–200071 recalls

FDA records 206 decisions for Johnson & Johnson Professionals, Inc. (Raynham, MA) from 1976 to 2000: 206 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and JWH (Prosthesis, Knee, Patellofemorotibial…). Its devices cite 55 predicates, 14 of them its own earlier devices. 71 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Johnson & Johnson Professionals, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Johnson & Johnson Professionals, Inc. since 2007.

Recalls per year

1in 2018

2007: 332009: 12011: 12012: 102013: 12018: 1
2007high 33 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Johnson & Johnson Professionals, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Johnson & Johnson Professionals, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Johnson”

FDA records each applicant name separately; these may or may not be the same firm.