Johnson & Johnson International: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Johnson & Johnson International” (first 1989, latest 1997), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 126 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
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 2 | 2 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 1 | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| KMF | Bandage, Liquid | 1 | 1 |
| KOZ | Beads, Hydrophilic, For Wound Exudate Absorption | 1 | 1 |
| OVZ | Pin, Fixation, Resorbable, Hard Tissue | 1 | 1 |
Review panels
Most recent Johnson & Johnson International 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K965198 | ULTIMA TPS CEMENTED STEM | KWL | 1997-07-23 | 209 |
| K944937 | SYNTHETIC ABSORBABLE SUTURE | GAM | 1995-05-19 | 225 |
| K946245 | TIELLE* HYDROPOLYMER DRESSING | KMF | 1995-04-11 | 110 |
| K942383 | DERMIVIEW CLEAR TAPE | KGX | 1994-08-22 | 95 |
| K922918 | BARRIER SAF-TE HYDROGEL DRAPE | KKX | 1993-07-06 | 383 |
| K923807 | P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS | JWH | 1992-11-09 | 103 |
| K896828 | BIOCLUSIVE(R) ABSORBENT DRESSING | KOZ | 1990-11-21 | 352 |
| K901456 | ORTHOSORB(R) ABSORBABLE PIN | OVZ | 1990-08-15 | 141 |
| K900638 | P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT | KWL | 1990-04-30 | 80 |
| K895207 | BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM | FRO | 1989-09-28 | 42 |
Recalls
openFDA lists no recalls under a recalling firm named Johnson & Johnson International.
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.
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 Professionals, Inc. (206 510(k)s)
- Johnson & Johnson Medical, Inc. (56 510(k)s)
- Johnson & Johnson Clinical Diagnostics, Inc. (33 510(k)s)
- Johnson & Johnson Orthopaedics, Inc. (22 510(k)s)
- Johnson & Johnson Vision Care, Inc. (12 510(k)s)
- Johnson & Johnson (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 and Johnson (2 510(k)s)
- Johnson & Johnson Company (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Johnson & Johnson International?
FDA lists 10 510(k) clearances under the applicant name “Johnson & Johnson International” (first 1989, latest 1997), across 9 product codes in 3 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 International?
The median time from FDA receipt to decision across 510(k)s cleared under the name Johnson & Johnson International is 126 days.
Which FDA product codes appear under Johnson & Johnson International?
The most frequent FDA product codes under this applicant name are KWL (Prosthesis, Hip, Hemi-, Femoral, Metal, 2); FRO (Dressing, Wound, Drug, 1); GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 1).
Next steps
- See all 10 Johnson & Johnson International clearances with predicates and recalls
- Run predicate analysis for product code KWL, Johnson & Johnson International'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.