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

GLG 1981-07-23

LABTRONIX PLATELET COUNTER(L/O/C.)

Applicant Labtronix Corp.

K-Number K811084

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JJQ 1981-07-23

ACCUDEX

Applicant Biodynamics Corp.

K-Number K811680

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GZJ 1981-07-23

VITATRON 88

Applicant Vitatronics

K-Number K811939

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IWL 1981-07-23

MODEL 4100 14 MEV NEUTRON GEN. THERAPY

Applicant The Cyclotron Corp.

K-Number K811778

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KSK 1981-07-21

FREEZE DRIED PAPAIN

Applicant Biological Corp. of America

K-Number K810803

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N/A 1981-07-21

OXYGEN CONTROLLER MODEL 145

Applicant Medix Medical Electronics (U.S.A.), Inc.

K-Number K812038

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KDC 1981-07-20

TIP WIPE

Applicant Devon Industries, Inc.

K-Number K811712

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DXY 1981-07-20

CORDIS OMNI-ARTICOR CARDIAC PACER #308

Applicant Cordis Corp.

K-Number K811691

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ILJ 1981-07-20

CENTURY HYDRO-SAN THERAPY TANK

Applicant Century Manufacturing Co.

K-Number K811904

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GDX 1981-07-20

AXICUT DISPOSABLE SCALPEL

Applicant Neonatal Corp.

K-Number K811707

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IYX 1981-07-20

ROTA CAMERA

Applicant Siemens Gammasonics, Inc.

K-Number K811715

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KOD 1981-07-20

CATH-DAP

Applicant Northwest Alabama Urological Assoc.

K-Number K811277

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