Medical Device Manufacturer · US , Walker , MI

Omni Intl., Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1982

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Omni Intl., Inc. General Hospital ✕

5 devices

1-5 of 5

Cleared Jan 13, 1999

OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM

General Hospital · 58d

Cleared Jan 08, 1999

OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE

General Hospital · 53d

Cleared Aug 23, 1985

OMNIMED I.V. SOLUTION ADMIN. SET

General Hospital · 21d

Cleared Jun 28, 1985

OMNIMED SURGICAL GOWN

General Hospital · 56d

Cleared Feb 22, 1985

OMNIMED IV SOLUTION ADMINISTRATION SET

General Hospital · 39d