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

LDF 1981-01-16

SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.

Applicant American Edwards Laboratories

K-Number K803058

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DTB 1981-01-16

ENDOCARDIAL LEADS 414S & 515S

Applicant Siemens Elema AB

K-Number K802816

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DTR 1981-01-16

CARDIOPLEGIC SETS

Applicant Texas Medical Products, Inc.

K-Number K802545

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CDD 1981-01-16

'NO-BOIL' VITAMIN B12 KIT

Applicant Diagnostic Products Corp.

K-Number K810002

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DXK 1981-01-16

MARK III ULTRASONIC SCANNING SYSTEM

Applicant Advanced Technology Laboratories, Inc.

K-Number K802917

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JJN 1981-01-16

AUTOMATED ELECTROPHORESIS SYSTEM

Applicant Helena Laboratories

K-Number K803281

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JJQ 1981-01-16

PHOTOMETER

Applicant Turner Designs, Inc.

K-Number K803285

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FKG 1981-01-16

DIALYIS START CARE KIT

Applicant Med-Pak Corp.

K-Number K802361

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KRI 1981-01-16

DISPOSABLE GAS LINE FILTER

Applicant Texas Medical Products, Inc.

K-Number K802539

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KPM 1981-01-15

CORDIS HAKIM ASCITES VALVE SYSTEM

Applicant Cordis Corp.

K-Number K803258

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FMF 1981-01-15

CYTOTRAN I BONE MARROW ASPIRATION SYSTEM

Applicant Applied Medical Devices, Inc.

K-Number K802406

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FMP 1981-01-15

SCANLAN VASCU-STATT

Applicant Scanlan Intl., Inc.

K-Number K802829

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