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 Osypka Medical with 7 510(k) clearances. The most recent is a 510(k) clearance dated Apr 9, 2013: PSA SERIES.
| Apr 9, 2013 | PSA SERIESK123916 · DTE | 510(k) clearances |
| Oct 8, 2008 | ICON, MODEL C3K082242 · DSB | 510(k) clearances |
| May 30, 2008 | AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2K081035 · DSB | 510(k) clearances |
| Feb 1, 2008 | AESCULON CHF, HYPERTENSION & PACEMAKER CLINICK070985 · DSB | 510(k) clearances |
| Oct 31, 2003 | PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATORK033130 · DTE | 510(k) clearances |
| Oct 3, 2002 | OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIESK022939 · DTE | 510(k) clearances |
| Jun 14, 2002 | OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENEK020896 · DTE | 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
