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

CAP 1980-01-09

RESPIRATOR DISCONNECT ALARM

Applicant Intersect Medical Products, Inc.

K-Number K792515

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ESD 1980-01-09

MODEL 339 TELECROS WIRELESS BICROS

Applicant Telex Communications, Inc.

K-Number K792462

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ELW 1980-01-09

SILAGUM

Applicant Parkell, Inc.

K-Number K792363

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EFQ 1980-01-09

TRACHEOTOMY SPONGE, NON-WOVEN DELNET

Applicant American Medical Disposable, Inc.

K-Number K792618

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EFQ 1980-01-09

TRACHEOTOMY SPONGE, NON-ADHERENT

Applicant American Medical Disposable, Inc.

K-Number K792613

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IWZ 1980-01-09

KODAK X-OMAT RP FILM

Applicant Eastman Kodak Company

K-Number K792517

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IWZ 1980-01-09

KODAK CFN FILM SO-224

Applicant Eastman Kodak Company

K-Number K792178

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DZE 1980-01-09

FLEXI-CUP IMPLANT

Applicant Impladent

K-Number K792663

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BWF 1980-01-04

DISPOSABLE INCENTIVE SPIROMETER

Applicant Hospitak, Inc.

K-Number K792598

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ELM 1980-01-04

TEETH, DENTURE, PLASTIC

Applicant Dentsply Intl.

K-Number K792245

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EIC 1980-01-04

ENDOVAGE SYRINGE

Applicant Dental Development Services, Inc.

K-Number K792577

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GEI 1980-01-04

OXIMETRIX SHAW HEMOSTATIC SURG. SYS.

Applicant Oximetrix, Inc.

K-Number K791868

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