Medical Device Manufacturer · US , Gainesville , FL

R-Group Intl. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1992

7

Total

7

Cleared

0

Denied

R-Group Intl. has 7 FDA 510(k) cleared medical devices. Based in Gainesville, US.

Historical record: 7 cleared submissions from 1992 to 2000. Primary specialty: General Hospital.

Browse the FDA 510(k) cleared devices submitted by R-Group Intl. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - R-Group Intl.

7 devices

1-7 of 7

Cleared Dec 13, 2000

ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S

General Hospital · 240d

Cleared Sep 18, 2000

ACTI-FLEX IV ADMINISTRATION SET

General Hospital · 117d

Cleared May 25, 2000

DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES

Obstetrics & Gynecology · 199d

Cleared Nov 28, 1995

ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.

General & Plastic Surgery · 186d

Cleared Sep 25, 1995

ACTI-FLEX ARTERIAL EXTENSION SET

Anesthesiology · 28d

Cleared Nov 10, 1994

R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE

General Hospital · 290d

Cleared Jun 05, 1992

R-GROUP INTL. ONE WALL PUNCTURE NEEDLE

Cardiovascular · 318d