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

JSH 1980-04-24

CHLAMYDOSPORE AGAR

Applicant Isle Media and Sterile Products, Inc.

K-Number K800818

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DYB 1980-04-24

THERMODILUTION CATHETER INTRO. KIT

Applicant Norton Performance Plastics Corp.

K-Number K800619

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DYB 1980-04-24

PERCUTANEOUS CATHETER INTRODUCER ADAPTER

Applicant Norton Performance Plastics Corp.

K-Number K800621

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KCD 1980-04-24

JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUE

Applicant Pilling Co.

K-Number K800623

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DQO 1980-04-24

SINGLE, 2&3 WAY SOLUTION SETS #14-070 ET

Applicant Norton Performance Plastics Corp.

K-Number K800618

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CHL 1980-04-21

IL MODEL 1303 PH/BLOOD GAS ANALYZER

Applicant Instrumentation Laboratory CO

K-Number K800757

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GEI 1980-04-21

DISPOSABLE PRE-GELLED ELECTROSURGICAL

Applicant Vxtra Corp.

K-Number K800557

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IKN 1980-04-21

CADWELL 7200

Applicant Cadwell Laboratories, Inc.

K-Number K800648

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CJM 1980-04-21

ALDOCTK-125

Applicant Sorin Biomedica, Fiat, USA, Inc.

K-Number K800775

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JIT 1980-04-21

SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT

Applicant Sclavo, Inc.

K-Number K800770

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ITG 1980-04-21

PRE-PADDED PLASTER/PARIS BAND/SPLINTS

Applicant Ortho-Care, Inc.

K-Number K800752

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HSX 1980-04-21

MEDICAL COMPARTMENT KNEE PROSTHESIS

Applicant Dow Corning Wright

K-Number K800640

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