Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

FLL 1980-09-16

SHILEY TEMPERATURE MONITOR

Applicant Shiley, Inc.

K-Number K802147

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HLM 1980-09-16

DIMENSION I REFRACTION SYSTEM

Applicant Smr

K-Number K801767

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KXF 1980-09-16

EYE APPLICATORS CAT.#980-983

Applicant Pollak (Intl.), Ltd.

K-Number K802016

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HQE 1980-09-16

CHARLES PNEUMATIC INTRAOCULAR SCISSORS

Applicant Cooper Medical Devices Corp.

K-Number K801850

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LEJ 1980-09-16

SUN VALLEY TANS

Applicant Sun Valley Tans, Inc.

K-Number K801543

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DTN 1980-09-16

SHILEY UTILITY RESERVOIR

Applicant Shiley, Inc.

K-Number K802119

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GWM 1980-09-16

INTRACRANIAL PRESSURING MONITORING SYST.

Applicant Pudenz-Schulte Medical Research Corp.

K-Number K802100

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EFQ 1980-09-16

GUAZE BALLS CAT.#601-720

Applicant Pollak (Intl.), Ltd.

K-Number K801999

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KYI 1980-09-16

SPINE ALIGN

Applicant B.H. Richardson, D.C.

K-Number K801952

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EFQ 1980-09-16

ABSORBENT PAD CAT.#729, 732, 730, 731

Applicant Pollak (Intl.), Ltd.

K-Number K802005

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LEJ 1980-09-16

SUN ROOM TANNING BOOTH

Applicant Sun Tan Enterprises, Inc.

K-Number K801674

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HWE 1980-09-16

C-BLADE

Applicant Cutter Laboratories, Inc.

K-Number K802105

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