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

JTY 1980-03-03

MARTIN-LEWIS AGAR

Applicant Isle Media and Sterile Products, Inc.

K-Number K800334

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HCC 1980-03-03

ALPHA DETECTOR

Applicant M.O.E Electronics Research & Prod.

K-Number K800319

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EAP 1980-03-03

XR-710

Applicant Pennwalt Corp.

K-Number K800063

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HIR 1980-03-03

ELECTRONIC PERINEOMETER

Applicant Associates IN Biofeedback

K-Number K800303

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JSJ 1980-03-03

CAMPYLOBACTER AGAR, CAT. NO. P2536

Applicant Gibco Laboratories Life Technologies, Inc.

K-Number K800329

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HQX 1980-03-03

SILASTIC SCLERAL SPONGE II W/CIRCLING BD

Applicant Dow Corning Corp. Healthcare Industries Materials

K-Number K800140

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DXN 1980-02-29

NIASTAT

Applicant Invivo Research Labs, Inc.

K-Number K800066

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DXW 1980-02-29

MODEL 412 ELECTROFLUIDIC MANOMETER

Applicant Med-Tek Corp.

K-Number K800222

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DKE 1980-02-29

DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG

Applicant California Medical Developments, Inc.

K-Number K792282

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DSH 1980-02-29

CIRCAMED I

Applicant Circadian, Inc.

K-Number K800214

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IQK 1980-02-29

BASHAW CERVICAL IMMOBILIZER DEVICE

Applicant Bashaw Custom Specialties, Inc.

K-Number K800108

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DSK 1980-02-29

OUTPUT DIGITAL DISPLAY MODULE, MOD. 611

Applicant Output, Inc.

K-Number K800360

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