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

FMQ 1977-09-28

PELVIC WHEELCHAIR RESTRAINT

Applicant Medical Restraints, Inc.

K-Number K771715

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FMQ 1977-09-28

FINGER MITT RESTRAINT

Applicant Medical Restraints, Inc.

K-Number K771632

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JFP 1977-09-28

NOVA 2 IONIZED CALCIUM ANALYZER

Applicant Nova Biomedical Corp.

K-Number K771643

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DXG 1977-09-28

CARDIOTHERM-500X

Applicant Columbus Instruments Intl. Corp.

K-Number K771718

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JOF 1977-09-26

BIOSPONGE RECONSTRUCTION DISCS

Applicant Xomed, Inc.

K-Number K771727

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GEN 1977-09-26

FORCEPS

Applicant Depuy, Inc.

K-Number K771746

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HQC 1977-09-26

FRAGMATOME MODEL 820

Applicant Berkeley Bio-Engineering

K-Number K771644

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FEX 1977-09-26

BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE.

Applicant Xomed, Inc.

K-Number K771725

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JOF 1977-09-26

BIOSPONGE STAPES PISTON

Applicant Xomed, Inc.

K-Number K771726

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IYO 1977-09-26

ECHO-OCULOMETER

Applicant Storz Instrument Co.

K-Number K771688

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FZT 1977-09-26

SURG. SCISSORS FOR CUTTING TISSUE

Applicant Depuy, Inc.

K-Number K771743

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BTI 1977-09-26

ADIDYNE 3000

Applicant Timeter Instrument Corp.

K-Number K771707

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