Beiersdorf, Inc.: FDA filings under this applicant name
FDA lists 45 510(k) clearances under the applicant name “Beiersdorf, Inc.” (first 1977, latest 2009), across 19 product codes in 5 review panels. Median 510(k) review time under this name: 92 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 |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | 15 | 15 |
| FPX | Strip, Adhesive, Closure, Skin | 6 | 6 |
| FRO | Dressing, Wound, Drug | 4 | 4 |
| FQM | Bandage, Elastic | 2 | 2 |
| KMF | Bandage, Liquid | 2 | 2 |
| KOD | Catheter, Urological | 2 | 2 |
| MGP | Dressing, Wound And Burn, Occlusive | 2 | 2 |
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | 1 | 1 |
| EZL | Catheter, Retention Type, Balloon | 1 | 1 |
| FZQ | Clip, Removable (Skin) | 1 | 1 |
Plus 9 more product codes.
Review panels
- General and Plastic Surgery (35)
- Gastroenterology and Urology (4)
- General Hospital (3)
- Orthopedic (1)
- Physical Medicine (1)
Most recent Beiersdorf, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090921 | ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02 | DWL | 2009-12-18 | 261 |
| K024057 | CURAD SCAR THERAPY | MDA | 2003-06-18 | 191 |
| K952526 | CUTINOVA CAVITY | KMF | 1995-08-14 | 74 |
| K943363 | CUTIPLAST STERIL | MGP | 1995-03-15 | 245 |
| K944581 | CUTINOVA THIN WOUND DRESSING | KMF | 1994-12-02 | 74 |
| K935630 | NORTA | EZL | 1994-10-07 | 318 |
| K940378 | COVERLET ADHESIVE DRESSING | KGX | 1994-07-29 | 184 |
| K925630 | ELASTOPLAST HEAT PLASTER | IRT | 1994-02-25 | 476 |
| K926399 | CUTIFILM(R) FILM | MGP | 1993-11-15 | 329 |
| K923404 | LUEKOFLEX SURGICAL TAPE | KGX | 1992-09-09 | 61 |
35 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Beiersdorf, 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.
- Beiersdorf-Jobt, Inc. (5 510(k)s)
- Beiersdorf AG (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Beiersdorf, Inc.?
FDA lists 45 510(k) clearances under the applicant name “Beiersdorf, Inc.” (first 1977, latest 2009), across 19 product codes in 5 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 Beiersdorf, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Beiersdorf, Inc. is 92 days.
Which FDA product codes appear under Beiersdorf, Inc.?
The most frequent FDA product codes under this applicant name are KGX (Tape And Bandage, Adhesive, 15); FPX (Strip, Adhesive, Closure, Skin, 6); FRO (Dressing, Wound, Drug, 4).
Next steps
- See all 45 Beiersdorf, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KGX, Beiersdorf, 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.