Overseas producers of LED phototherapy masks, RF microneedling handpieces, patient monitors, dental zirconia blocks, and surgical consumables requiring 510(k) premarket clearance and FURLS listing.
Download the normalized 5-year Excel dataset with FEI/DUNS mappings and FSVP checklists.
Buy Cleaned 5-Yr Excel ($39 • Gumroad Instant Checkout)A Class I/II medical or aesthetic device was shipped to a US port without a valid FDA 510(k) clearance number or establishment registration.
The product (often a skincare serum, device, or dietary supplement) uses medical or disease-cure claims on its packaging or website without an approved NDA/ANDA.
An FDA foreign inspection (Form FDA 483) or cGMP audit found systemic facility sanitation failures, non-sterile ophthalmic/OTC water systems, or pest harborage.
OEM manufacturer of home-use LED red-light therapy masks, IPL hair removal handsets, and RF fractional microneedling devices. Detained when white-label buyers declare Class I exempt codes while shipping Class II energy devices without a valid 510(k) PM# or with clinical wound-healing claims.
Nearshore ISO 13485 medical disposable and catheter kit maquiladora serving US hospital distributors. Low risk score; single historical hold stemmed from a broker inputting an expired device listing code on a new SKU.
Across 5-year CBP/FDA OASIS records, Class I/II Medical, Dental & Aesthetic Devices (FDA Industry Code 73–89 (Medical & Aesthetic Devices)) experiences a 21.2% detention rate among flagged overseas shippers with an average port hold of 28 calendar days across Los Angeles, Miami, Newark.
The primary statutory charge codes for Medical Devices are NO_510K, UNAPPROVED_NEW_DRUG, INSANITARY_CONDITIONS. Key active Import Alerts include Import Alert 89-08 (Devices Without Cleared 510(k) or PMA); Import Alert 89-04 (Quality System Regulation 21 CFR 820 / QMSR Failures); Import Alert 80-04 (Substandard Gloves & Barrier Devices). Historical refusal logs do not certify future admissibility.