Johnson & Johnson Medical, Div. of Ethicon, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Johnson & Johnson Medical, Div. of Ethicon, Inc.” (first 1998, latest 1999), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 71 days. 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 Johnson & Johnson MedTech, based on public ownership records.
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 |
|---|---|---|---|
| MGP | Dressing, Wound And Burn, Occlusive | 2 | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FYA | Gown, Surgical | 1 | 1 |
| KGO | Surgeon'S Gloves | 1 | 1 |
Review panels
Most recent Johnson & Johnson Medical, Div. of Ethicon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990236 | MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT | FOZ | 1999-08-20 | 207 |
| K990395 | BARRIER SURGICAL GOWNS | FYA | 1999-04-13 | 63 |
| K983240 | NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES | KGO | 1998-11-30 | 76 |
| K983234 | TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING | MGP | 1998-11-25 | 71 |
| K983394 | MODIFICATION TO TIELLE HYDROPOLMER DRESSING | MGP | 1998-11-03 | 39 |
Recalls
openFDA lists no recalls under a recalling firm named Johnson & Johnson Medical, Div. of Ethicon, 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.
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 International (10 510(k)s)
- Johnson & Johnson Consumer Products, Inc. (8 510(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 Medical, Div. of Ethicon, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Johnson & Johnson Medical, Div. of Ethicon, Inc.” (first 1998, latest 1999), across 4 product codes in 2 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 Medical, Div. of Ethicon, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Johnson & Johnson Medical, Div. of Ethicon, Inc. is 71 days.
Which FDA product codes appear under Johnson & Johnson Medical, Div. of Ethicon, Inc.?
The most frequent FDA product codes under this applicant name are MGP (Dressing, Wound And Burn, Occlusive, 2); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 1); FYA (Gown, Surgical, 1).
Next steps
- See all 5 Johnson & Johnson Medical, Div. of Ethicon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MGP, Johnson & Johnson Medical, Div. of Ethicon, 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.