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., part of ColoplastLabelled 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 Rochester Medical with 13 510(k) clearances. The most recent is a 510(k) clearance dated May 14, 2013: HYDROSIL; MAGIC; PERSONAL CATHETER.
| May 14, 2013 | HYDROSIL; MAGIC; PERSONAL CATHETERK122785 · EZD | 510(k) clearances |
| Jun 10, 2004 | HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KITK033477 · MJC | 510(k) clearances |
| Jul 7, 2000 | RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETERK001143 · MJC | 510(k) clearances |
| May 19, 2000 | HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)K000723 · KOD | 510(k) clearances |
| Jul 8, 1998 | ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETERK981612 · EZL | 510(k) clearances |
| Jan 13, 1998 | SILICONE ANTIBACTERIAL FOLEY CATHETERK971627 · MJC | 510(k) clearances |
| Mar 13, 1997 | PERSONAL CATHETERK970704 · GBM | 510(k) clearances |
| Jul 18, 1995 | ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETERK952082 · EXJ | 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
