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

DXY 1980-12-22

MICRO THIN-PII, #0523

Applicant Cardiac Pacemakers, Inc.

K-Number K802353

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JJY 1980-12-22

CHEM-ASSAY STANDARD-CONTROLS

Applicant National Bio-Technical Laboratories

K-Number K802962

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JSI 1980-12-22

ORICULT DTM

Applicant Orion Diagnostica, Inc.

K-Number K802947

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LAS 1980-12-22

AMES TDA AMIKACIN CONTROL SERUM

Applicant Miles Laboratories, Inc.

K-Number K803107

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DIF 1980-12-22

DIGOXIN & PHENYTOIN CONTROL SERA

Applicant Amersham Corp.

K-Number K803097

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CBZ 1980-12-22

SENSOMAT

Applicant Biochem International, Inc.

K-Number K803014

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DIF 1980-12-22

PROFILE ANTI-CONVUL. SET ASSAYED S. CTL.

Applicant General Diagnostics

K-Number K803039

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DIF 1980-12-22

PROFILE CARDIAC SET ASSAYED SERUM CONTR.

Applicant General Diagnostics

K-Number K803036

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JJX 1980-12-22

HDL-CHOLESTEROL CONTROL SERUM

Applicant Isolab, Inc.

K-Number K802997

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FIE 1980-12-22

GAMBRO A-V FISTULA NEEDLE SET

Applicant Gambro, Inc.

K-Number K802956

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CBK 1980-12-20

DRAGER AV2 ANESTHESIA VENTILATOR

Applicant Draeger Medical, Inc.

K-Number K802168

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CAP 1980-12-19

MONITOR, AIRWAY PRESSURE

Applicant Novametrix Medical Systems, Inc.

K-Number K802955

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