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 Rondex Products, Inc. with 11 510(k) clearances. The most recent is a 510(k) clearance dated May 19, 1998: RONDEX CPR ISO-SHIELD.
| May 19, 1998 | RONDEX CPR ISO-SHIELDK981169 · CBP | 510(k) clearances |
| Feb 7, 1995 | CPR SHIELDK942671 · CBP | 510(k) clearances |
| Nov 10, 1994 | NON-BREATHING VALVEK943761 · CBP | 510(k) clearances |
| Oct 6, 1992 | RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIEDK921002 · BTM | 510(k) clearances |
| Nov 8, 1991 | RONDEX MASKS MODELS 9015/9011/901102 MODIFIEDK914196 · BTM | 510(k) clearances |
| Nov 8, 1991 | RONDEX CPR NON REBREATHING VALVE #9030, MODIFIEDK914195 · CBP | 510(k) clearances |
| Oct 26, 1990 | CPR VALVE (NON-REBREATHING) MODEL #9030K902299 · CBP | 510(k) clearances |
| Aug 22, 1990 | ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GASK902298 · BSJ | 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
