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

GCY 1982-08-16

LARGE VOLUME CLOSED WOUND SUCTION DRAIN

Applicant American Heyer Schulte

K-Number K822032

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FMF 1982-08-16

U-100 INSULIN SYRINGE

Applicant Terumo Medical Corp.

K-Number K822083

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FKX 1982-08-16

DIANEAL SOLUTION EXCHANGE DEVICE #5C4193

Applicant Travenol Laboratories, S.A.

K-Number K822361

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KAD 1982-08-16

ENT ELEVATORS

Applicant Kelleher Corp.

K-Number K822190

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GWN 1982-08-16

NAGASHIMA KN-52 SACCADE & PURSUIT STIM

Applicant Kelleher Corp.

K-Number K822266

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FLN 1982-08-16

I.V. SENTINEL

Applicant The John Bunn Co.

K-Number K821823

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N/A 1982-08-16

LIGHT PEN ACCESSORY FOR USE WITH FETASCAN 800 SERIES

Applicant Cranston Medical Laboratory

K-Number K827712

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N/A 1982-08-16

SIREMOBILE 3

Applicant Siemens Medical Solutions USA, Inc.

K-Number K827792

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CGJ 1982-08-16

IMMO PHASE FSH RADIOIMMUNOASSAY

Applicant Corning Medical & Scientific

K-Number K822227

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JOJ 1982-08-16

MEDI + BIO SAFE STEAM STERILIZ. INDICAT

Applicant Arvey Corp.

K-Number K821997

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N/A 1982-08-16

SINUSON 810 ULTRASOUND SCANNER

Applicant Am Labs, Inc.

K-Number K827663

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BTC 1982-08-16

ANESTHESIA BREATHING BAG, VARIOUS SIZES

Applicant Life Design Systems, Inc.

K-Number K822116

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