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

GMT 1979-11-13

BACTO-HATTS

Applicant Difco Laboratories, Inc.

K-Number K791897

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N/A 1979-11-07

ELA MEDICAL ANATEC HOLTER SCANNER

Applicant Ela Medical, Inc.

K-Number K792239

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JBQ 1979-11-05

PHADECODE XA INHIBITOR ASSAY

Applicant Pharmaseal Div., Baxter Healthcare Corp.

K-Number K792019

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HHK 1979-11-05

MASTERSON* ENDOMETRIAL BIOPSY KIT

Applicant Codman & Shurtleff, Inc.

K-Number K791765

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DTB 1979-11-05

CORDIS PERMANENT PERVENOUS CARDIAC LEADS

Applicant Cordis Corp.

K-Number K791768

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BZG 1979-11-05

MINISPIROMETER SP-1

Applicant Renesco International, Inc.

K-Number K791422

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FYI 1979-11-05

CONPHAR O.R. HEAD COVER-STERILE

Applicant Conphar, Inc.

K-Number K792106

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IXR 1979-11-05

SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM

Applicant Spectrum X-Ray Corp.

K-Number K791812

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ESD 1979-11-05

RIONET HEARING AID HB-65T

Applicant Rion Acoustic Instruments, Inc.

K-Number K791881

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GDI 1979-11-05

DISPOSABLE SPECIALITY SPONGES

Applicant Carwild Corp.

K-Number K791870

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N/A 1979-11-05

HOLLOW FIBER DIALIZER MODEL TRIEX-3

Applicant Extracorporeal Medical Specialities, Inc.

K-Number K791857

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GHM 1979-11-05

MONOJECT SICKLE CELL KIT

Applicant Sherwood Medical Co.

K-Number K791971

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