Medical Device Manufacturer · US , Mchenry , IL

Pollak (Intl.), Ltd. - FDA 510(k) Cleared Devices

31 submissions · 31 cleared · Since 1980

Recent clearances: UMBICUT, PEDICAT*, VECAFIX*

Total

Cleared

Denied

Pollak (Intl.), Ltd. has 31 FDA 510(k) cleared medical devices. Based in Mchenry, US.

Historical record: 31 cleared submissions from 1980 to 2000. Primary specialty: General & Plastic Surgery.

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

Pollak (Intl.), Ltd. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Pollak (Intl.), Ltd.

31 devices

1-12 of 31

Cleared Apr 27, 2000

UMBICUT

K000227 · HFW

Obstetrics & Gynecology · 94d

Cleared Apr 21, 1981

PEDICAT*

K810049 · KMJ

General Hospital · 98d

Cleared Mar 26, 1981

VECAFIX*

K810050 · KGX

General & Plastic Surgery · 72d

Cleared Oct 31, 1980

FLOWCLAMP CAT.#1011 & 1012

K802009 · FKK

Gastroenterology & Urology · 72d

Cleared Oct 31, 1980

INFUSSION ALARM SYSTEM I.A.S. CAT.#1118

K802011 · FLN

General Hospital · 72d

Cleared Oct 10, 1980

DRESSING CHANGE SET CAT.#910-930

K802017 · KDD

General & Plastic Surgery · 51d

Cleared Sep 26, 1980

PEDIWET=GUAZE IMPREGNATED WITH PETROL

K802007 · FRQ

Gastroenterology & Urology · 37d

Cleared Sep 16, 1980

PLASTIC FORCEPS CAT.#1001-1010

K801991 · GEN

General & Plastic Surgery · 27d

Cleared Sep 16, 1980

GUAZE BANDAGES CAT.#101-169

K801996 · NAB

General & Plastic Surgery · 27d

Cleared Sep 16, 1980

GUAZE BALLS CAT.#601-720

K801999 · EFQ

General & Plastic Surgery · 27d

Cleared Sep 16, 1980

LAP SPONGES CAT.#801-850

K802001 · KKX

General Hospital · 27d

Cleared Sep 16, 1980

PROFILE SWAB CAT.#5273 & 5274

K802004 · KXG

General & Plastic Surgery · 27d

Pollak (Intl.), Ltd. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Pollak (Intl.), Ltd.

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