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 its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Sierra Laboratories, Inc. with 12 510(k) clearances. The most recent is a 510(k) clearance dated Apr 22, 1997: COMFORT CATH CHOICE MALE EXTERNAL CATHETER.
| Apr 22, 1997 | COMFORT CATH CHOICE MALE EXTERNAL CATHETERK970966 · EXJ | 510(k) clearances |
| Jul 15, 1996 | COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETERK962413 · EXJ | 510(k) clearances |
| Jul 15, 1996 | COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETERK962384 · EXJ | 510(k) clearances |
| Apr 19, 1994 | COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETERK934266 · EXJ | 510(k) clearances |
| Jan 7, 1994 | ALPINE REUSABLE LEG BAGSK934052 · FAQ | 510(k) clearances |
| Jul 1, 1993 | CONE CATHK931156 · EXJ | 510(k) clearances |
| Mar 26, 1990 | URO TEX URINALSK901000 · EYZ | 510(k) clearances |
| Aug 2, 1988 | COMFORT CATH MALE EXTERNAL CATHETERK883057 · EYT | 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
