Medical Device Manufacturer · US , Walker , MI

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

12 submissions · 12 cleared · Since 1982

Total

Cleared

Denied

Omni Intl., Inc. has 12 FDA 510(k) cleared medical devices. Based in Walker, US.

Historical record: 12 cleared submissions from 1982 to 1999. Primary specialty: General Hospital.

Browse the FDA 510(k) cleared devices submitted by Omni Intl., Inc. Filter by specialty or product code using the sidebar.

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

12 devices

1-12 of 12

Cleared Jan 13, 1999

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

K984066 · KGO

General Hospital · 58d

Cleared Jan 08, 1999

OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE

K984064 · KGO

General Hospital · 53d

Cleared Aug 23, 1985

OMNIMED I.V. SOLUTION ADMIN. SET

K853255 · FPA

General Hospital · 21d

Cleared Jun 28, 1985

OMNIMED SURGICAL GOWN

K851938 · FYA

General Hospital · 56d

Cleared May 31, 1985

OMNIMED CLAMP

K851654 · HXD

General & Plastic Surgery · 39d

Cleared May 23, 1985

OMNIMED SUPERIOR TRANSDUCER PROTECTOR

K851734 · FIB

Gastroenterology & Urology · 28d

OMNIMED IV SOLUTION ADMINISTRATION SET

K850112 · FPA

General Hospital · 39d

Cleared Jan 24, 1985

OMNIMED NASAL OXYGEN CANNULA

K850066 · CAT

Anesthesiology · 16d

Cleared Jul 18, 1983

OMNIPROBE ELECTRICAL NERVE STIMULATOR

Physical Medicine · 70d

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

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

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