Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Medical Designs, LLC with 7 510(k) clearances. The most recent is a 510(k) clearance dated Nov 21, 2018: SP-LINK™ System.
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.
| Nov 21, 2018 | SP-LINK™ SystemK182352 · PEK | 510(k) clearances |
| Sep 26, 2018 | Fixated Asfora BULLET CAGE® (FABC)K181591 · MAX | 510(k) clearances |
| Jul 1, 2015 | ASFORA ANTERIOR CERVICAL PLATE SYSTEMK143688 · KWQ | 510(k) clearances |
| Mar 13, 2012 | ASFORA BULLET CAGEK112648 · MAX | 510(k) clearances |
| Aug 14, 2009 | ASFORA BULLET CAGE SYSTEMK090048 · MAX | 510(k) clearances |
| Nov 17, 2004 | SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CALK042359 · JXG | 510(k) clearances |
| Dec 12, 2000 | SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901K002970 · JXG | 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
