Data / Medical devices / Tissue Adhesive For The Topical Approximation Of Skin
Tissue Adhesive For The Topical Approximation Of Skin (MPN): 15 FDA-registered makers in 6 countries
15 establishments in 6 countries are registered with the FDA to make Tissue Adhesive For The Topical Approximation Of Skin (product code MPN, Class 2, 21 CFR 878.4010). 13 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 36 510(k) clearances under this code, the latest on September 19, 2025, and lists 2 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- MPN
- Device class
- 2
- Regulation
- 878.4010
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Spain | 2 |
| United Kingdom | 1 |
| Germany | 1 |
| Canada | 1 |
| India | 1 |
Makers of Tissue Adhesive For The Topical Approximation Of Skin
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| H.B. Fuller Medical Adhesive Technologies, LLC | Hudson, NC, United States | Manufacturer, Repackager or relabeler, Specification developer | 6 | May 13, 2014 | 0 | 0 | 0 | api.fda.gov |
| Advanced Medical Solutions Limited | PLYMOUTH Devon, United Kingdom | Manufacturer | 5 | March 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Chemence Medical Inc. | Alpharetta, GA, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 5 | September 9, 2021 | 0 | 0 | 0 | api.fda.gov |
| Covidien | North Haven, CT, United States | Repackager or relabeler, Specification developer | 2 | October 26, 2015 | 1 | 0 | 0 | api.fda.gov |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Ethicon, Inc. | Somerville, NJ, United States | Manufacturer | 1 | October 22, 2015 | 0 | 1 | 0 | api.fda.gov |
| Ethicon, Inc. | Raritan, NJ, United States | Specification developer | 1 | October 22, 2015 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, LLC. | San Lorenzo, PR, United States | Manufacturer | 1 | October 22, 2015 | 0 | 0 | 0 | api.fda.gov |
| Glustitch, Inc. | Delta British Columbia, Canada | Manufacturer | 1 | January 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| Meril Endo Surgery Pvt. Ltd. | Vapi Gujarat, India | Manufacturer | 1 | March 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Distribution Center | Memphis, TN, United States | Manufacturer | 1 | October 26, 2015 | 0 | 0 | 0 | api.fda.gov |
| Okapi Medical Dba Resivant Medical | Akron, OH, United States | Manufacturer | 1 | August 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| OptMed, Inc | New York, NY, United States | Complaint file establishment, Specification developer | 1 | September 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Surgical, S.A. | Rubi Barcelona, Spain | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synkotech Biocompatible Materials | Reus Tarragona, Spain | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 19, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.