Medical Device Manufacturer · US , Walker , MI

Directed Energy, Inc. - FDA 510(k) Cleared Devices

39 submissions · 38 cleared · Since 1984

39

Total

38

Cleared

0

Denied

FDA 510(k) Regulatory Record - Directed Energy, Inc. Obstetrics & Gynecology ✕

4 devices

1-4 of 4

Cleared Feb 02, 1988

MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN

Obstetrics & Gynecology · 341d

Cleared Feb 02, 1988

MODEL 20-C, RL-20A/U, OB-10A/U

Obstetrics & Gynecology · 210d

Cleared Oct 27, 1986

SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE

Obstetrics & Gynecology · 90d

Cleared Aug 11, 1986

MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE

Obstetrics & Gynecology · 90d