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

JHI 1978-08-31

HUMAN CHORIONIC GONADO.-BETA RIA KIT

Applicant Diagnostics Biochem Canada, Inc.

K-Number K781310

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CEE 1978-08-31

GLOBULIN TEST, HUMAN THYROXINE BINDING

Applicant Hyland Therapeutic Div., Travenol Laboratories

K-Number K781225

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ERL 1978-08-31

XOMED TRANSSPHENOIDAL HANDPIECE

Applicant Xomed, Inc.

K-Number K781418

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JSS 1978-08-31

ENTEROTUBE II

Applicant Hoffmann-La Roche, Inc.

K-Number K781236

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DTB 1978-08-31

PACEMAKER, ELECTRODE, PERMANENT & TEMP.

Applicant Daig Corp.

K-Number K780246

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JDW 1978-08-31

THREADED PIN, SELF DRILLING

Applicant Ace Orthopedic Manufacturing Co.

K-Number K781251

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FMC 1978-08-31

GLOVES, PROCEDURE

Applicant Arbrook Mfg. Corp.

K-Number K781278

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DOG 1978-08-31

DIGOXIN RIA (PEG) KIT

Applicant Ortho Diagnostics, Inc.

K-Number K781335

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N/A 1978-08-31

TEST MODULE MODEL DM-352

Applicant Extracorporeal Medical Specialities, Inc.

K-Number K781215

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DXY 1978-08-31

GENERATOR, PULSE, PACEMAKER

Applicant Vitatron Medical BV

K-Number K781168

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HZG 1978-08-31

LIPOPROTEIN STAIN

Applicant Electrophoresis Corp. of America

K-Number K781122

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ESD 1978-08-31

HEARING AID, UNITRON MODEL 975

Applicant Unitron Industries, Inc.

K-Number K781434

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