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 R-Group International with 7 510(k) clearances. The most recent is a 510(k) clearance dated Dec 13, 2000: ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S.
| Dec 13, 2000 | ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D SK001233 · FPA | 510(k) clearances |
| Sep 18, 2000 | ACTI-FLEX IV ADMINISTRATION SETK001599 · FPA | 510(k) clearances |
| May 25, 2000 | DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODESK993777 · HGI | 510(k) clearances |
| Nov 28, 1995 | ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.K952470 · GCD | 510(k) clearances |
| Sep 25, 1995 | ACTI-FLEX ARTERIAL EXTENSION SETK954035 · CBT | 510(k) clearances |
| Nov 10, 1994 | R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINEK940319 · FPA | 510(k) clearances |
| Jun 5, 1992 | R-GROUP INTL. ONE WALL PUNCTURE NEEDLEK913267 · DRC | 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
