In FDA's registration and listing files exported 2026-09-07, 151 of China's 4,704 registered device manufacturing establishments list a product code FDA flags as an implant, 3.2%, against 18.7% of the 6,502 in the United States. Vietnam has nine implant-listing establishments, Thailand eight.
| Measure | Week ending | Change |
|---|---|---|
| 510(k) clearances | 51 | +2 |
| Recalls posted | 25 | +2 |
| Class I recalls posted | 1 | level |
| PMA decisions | 50 | +13 |
Of the process-change supplements FDA received in 2015-2023, 927 records were converted from the 30-day notice route to the 135 Review Track, 6.3% of the notices filed. For notices received in 2018-2023, those supplements were approved a median 204 calendar days after receipt.
FDA entered termination dates on 288 recall records (72 recall events) in 2025, against 1,607 recall records (527 recall events) in 2024. Of recall records initiated in the first half of 2023, 2.6% were terminated within three years, against 89% of those initiated in 2016.
The RES endpoint reaches back to late 2002. The enforcement endpoint, the only one carrying Class I, II and III, holds 0 records dated before 2012-06-20, so 7,527 of the 22,500 recall events in RES (33.45%) have no severity in the API.
The firm told FDA that select lots may carry a protrusion that could cause genitourinary trauma. The record names process control as the cause, which is the answer FDA's file gives more often than any other.
FDA's recall record carries the firm's own answer to why. In every year since 2021, more recalls name the process that built the device than name the device's design. On close to a quarter of 2025's recalls the firm had named nothing at all.
