Medical Device Manufacturer · US , Hartsdale , NY

Infarkem Corp. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1985

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Infarkem Corp. General Hospital ✕

2 devices

1-2 of 2

Cleared Sep 19, 1985

FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20)

General Hospital · 92d

Cleared May 30, 1985

IV/0165 INFUSION SET

General Hospital · 57d