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

DRT 1980-09-26

HEARTWATCH

Applicant D. Jenkins

K-Number K800519

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DXY 1980-09-26

BIFOCAL 2 8200 SERIES (A,B C,D)

Applicant American Pacemaker Corp.

K-Number K800379

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KRB 1980-09-26

BENTLEY THEROMODILUTION CATHETER #BTD-7F

Applicant Bentley Laboratories, Inc.

K-Number K802133

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GAD 1980-09-26

ETHICON RETRACTION TAPE

Applicant ETHICON, Inc.

K-Number K801699

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KNX 1980-09-26

URIHESIVE SYSTEM

Applicant E. R. Squibb & Sons, Inc.

K-Number K802172

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IZO 1980-09-26

BR 2002 X-RAY GENERATOR SYSTEM

Applicant Valmet Indus. Mach. & Prod., Inc.

K-Number K801808

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CAP 1980-09-26

DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC

Applicant Draeger Medical, Inc.

K-Number K802090

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JJE 1980-09-26

MODEL 203S CLINICAL CHEMISTRY ANALYZER

Applicant Gilford Instrument Laboratories, Inc.

K-Number K801889

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KDK 1980-09-26

KEITHLEY LYMPHOCYTE DEPLETION CART

Applicant Keithley Development Co.

K-Number K801899

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DXY 1980-09-26

PROGRAMALITH #'S 221, 222, 221A & 222A

Applicant Pacesetter Systems

K-Number K801978

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FIF 1980-09-26

MEDCOMP FEMORAL VEIN CATHETER

Applicant Medical Components, Inc.

K-Number K801967

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DWX 1980-09-26

HALL ARTERIAL OSCILLATOR

Applicant American Sterilizer Co.

K-Number K801063

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