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. Ear, Nose, Throat ✕

5 devices

1-5 of 5

Cleared Sep 24, 1987

MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT

Ear, Nose, Throat · 79d

Cleared Jun 12, 1987

MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH

Ear, Nose, Throat · 106d

Cleared Jan 09, 1987

MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE

Ear, Nose, Throat · 164d

Cleared Jan 09, 1987

MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE

Ear, Nose, Throat · 164d

Cleared Sep 04, 1986

MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)

Ear, Nose, Throat · 92d