45% of US Tissue Adhesive Listings Lack Own Clearance
Weihai, China – October 29, 2026 -- Nine of the 20 labelers in the FDA's GUDID database for topical tissue adhesives hold no clearance of their own, yet they account for 44 of 97 device records (45%), according to a September 2026 supplier-landscape report from VEMERIX, the international brand of Weihai Medison Medical Equipment Co., Ltd. The company has distilled the findings into a document checklist for buyers sourcing medical cyanoacrylate adhesives in bulk.
US clearances concentrate in 14 applicant groups, four of which hold 23 of 36
The report counts 36 FDA 510(k) clearances under product code MPN (topical tissue adhesives) between December 2008 and September 2025. Four companies hold 23 of them. The 45% figure reflects lawful private-label and relabeling arrangements, through which much of the category reaches the market, and describes traceability rather than compliance.