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

N/A 1983-03-17

CONTROLLEX LS-5

Applicant Elscint, Inc.

K-Number K837177

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N/A 1983-03-17

HI-LO RADIOLOGICAL STRETCHER

Applicant Elscint, Inc.

K-Number K837183

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N/A 1983-03-17

ULTRASONIC ECHOSCOPE

Applicant Ausonics Pty , Ltd.

K-Number K837171

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IAF 1983-03-17

HEMAQUIK II STAINING SOLUTION #55961

Applicant Accra Laboratories, Inc.

K-Number K830542

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FKX 1983-03-17

AMP 80/2 OUTFLOW MONITOR MODIFICATION

Applicant American Medical Products, Inc.

K-Number K823827

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LKB 1983-03-17

SAVETT ALCOHOL PREP

Applicant Cederroth, Inc. USA

K-Number K830330

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N/A 1983-03-17

DOSIMETRY RELEASE OF RADIATION STERIL.

Applicant Biomet, Inc.

K-Number K823059

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FLL 1983-03-17

LUER LOCK TEMPERATURE SENSOR

Applicant Mon-A-Therm, Inc.

K-Number K830552

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GDY 1983-03-17

ZANLEX, ZAN-TEX & ZANDEX

Applicant Winn Hirsch & Assoc.

K-Number K830511

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HRX 1983-03-17

IMPROVED ARTHROSCOPE

Applicant Markoptic

K-Number K830120

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DTB 1983-03-17

PACING LEAD #PMA F 860

Applicant Ela Medical, Inc.

K-Number K830457

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BTL 1983-03-17

RAD VALVE

Applicant Khi, Inc.

K-Number K830404

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