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

KGY 1980-08-20

BAND-AID BRAND TRICOT MESH BANDAGES

Applicant Johnson & Johnson Professionals, Inc.

K-Number K801823

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LEJ 1980-08-20

CLASSIC TAN TANNING BOOTH

Applicant Classic Tan, Inc.

K-Number K801521

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KRE 1980-08-14

ELECTRONIC PACEMAKER WAVEFORM ANALYZER

Applicant Instromedix, Inc.

K-Number K800696

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KNC 1980-08-14

ADEL MEDICAL BIRTHING BED, MOD. LD-400

Applicant Adel Medical , Ltd.

K-Number K801622

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KXO 1980-08-14

MMI/GAELTEC CATHETER INTRAUTERINE

Applicant Medical Measurements, Inc.

K-Number K801758

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BSY 1980-08-14

CATHETER SUCTION TRACHEOBRONCHIAL

Applicant Concord Laboratories, Inc.

K-Number K801814

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DXY 1980-08-14

INTERMEDICS THIN LITH IV SERIES UNIPOLAR

Applicant Intermedics, Inc.

K-Number K801450

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GIF 1980-08-14

MODIFIED BLOOD CELL COUNTING & LYSING

Applicant Coulter Electronics, Inc.

K-Number K801357

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CAF 1980-08-14

CIRCUITS, BREATHING W/CONNECTORS, ADAPT

Applicant Airlife, Inc.

K-Number K801875

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BYR 1980-08-14

MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS

Applicant Medical Measurements, Inc.

K-Number K801880

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GZJ 1980-08-14

NEUROGAR III-TRANSCUT. ELEC. NERVE STIM

Applicant Inter Med Industries, Inc.

K-Number K801576

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ESD 1980-08-14

RIONET HEARING AID AND/OR RION #HB-70

Applicant Rion Acoustic Instruments, Inc.

K-Number K801692

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