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

DXH 1980-09-26

CARDIOTRAK

Applicant Cardiac Pacemakers, Inc.

K-Number K802089

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GMJ 1980-09-26

IMMUNO. IDENTIFICATION OF H. CAPSULATUM

Applicant Nolan Biological Laboratories, Inc.

K-Number K802130

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JFH 1980-09-26

NORDICLAB PROSTATIC ACID PHOSPHATASE RIA

Applicant Nordiclab Intl.

K-Number K801988

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BYW 1980-09-26

SHERWOOD VENTILATORY MUSCLE TRAINER

Applicant Sherwood Medical Co.

K-Number K802165

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DSI 1980-09-26

COMPUTER ECG TERMINAL

Applicant Compumed, Inc.

K-Number K802272

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DHX 1980-09-26

CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL

Applicant Environmental Chemical Specialties

K-Number K792377

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LET 1980-09-26

AMES TDA PHENOBARBITAL TEST

Applicant Miles Laboratories, Inc.

K-Number K802255

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JTO 1980-09-26

API-CTS STREPTOCOCCUS

Applicant Analytical Products, Inc.

K-Number K801951

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DXG 1980-09-26

BIOMETRIC SYSTOLIC TIME INTERVAL SYSTEM

Applicant Biometric Analysis Group, Inc.

K-Number K802198

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BZR 1980-09-26

SECHRIST SERIES 3500 AIR-OXYGEN MIXER

Applicant Sechrist Industries, Inc.

K-Number K802226

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DXY 1980-09-26

IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN

Applicant Telectronics, Inc.

K-Number K802028

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FYF 1980-09-26

DISPOSABLE NURSES CAP

Applicant Anago, Inc.

K-Number K802186

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