Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list PFM Medical with 20 510(k) clearances and 10 device recalls. The most recent is a device recall dated Apr 21, 2026: Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 21, 2026 | Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310Class II · A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, fa | Device recalls |
| May 2, 2025 | JetCan® Pro Safety Huber NeedleK242763 · FPA | 510(k) clearances |
| Jan 14, 2025 | ASEPT® Glide Peritoneal Drainage SystemK241278 · PNG | 510(k) clearances |
| May 2, 2023 | ASEPT Peritoneal Drainage SystemK221779 · PNG | 510(k) clearances |
| Oct 6, 2022 | NuCath Wedge Pressure CatheterK213666 · DQO | 510(k) clearances |
| Aug 19, 2020 | Asept Surgical Face MaskK201137 · FXX | 510(k) clearances |
| Oct 28, 2019 | primeMidline CathetersK192802 · PND | 510(k) clearances |
| Mar 7, 2018 | primeMidline CathetersK173114 · PND | 510(k) clearances |
| Mar 25, 2014 | SAFETY BIOPSY NEEDLE SYSTEMK140137 · FCG | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built