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 1979-05-16

OMNI-STANICOR-(THETA) MODEL 217

Applicant Cordis Corp.

K-Number K790690

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ESD 1979-05-16

HSI MODEL C. CUSTOM IN-THE-EAR HEAR/AID

Applicant Hearing Services, Inc.

K-Number K790737

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DJB 1979-05-15

EMIT GENTAMICIN ASSAY

Applicant Syva Co.

K-Number K790829

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KHP 1979-05-15

ROCHE LACTATE ANALYZER 640

Applicant Roche Medical Electronics, Inc.

K-Number K790421

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LAS 1979-05-15

EMIT GENTAMICIN CONTROL

Applicant Syva Co.

K-Number K790830

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ITI 1979-05-15

PERMOBIL EXTERIOR

Applicant Saab-Scania of America, Inc.

K-Number K790858

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FRN 1979-05-15

BLOOD CELL SEPARATOR SYSTEM CS3000

Applicant Travenol Laboratories, S.A.

K-Number K790315

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CDX 1979-05-15

NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM

Applicant Micromedic Systems

K-Number K790665

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IGM 1979-05-15

CULTURETTE BRAND PVA

Applicant Marion Laboratories, Inc.

K-Number K790815

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CIG 1979-05-15

GAMMA SMAC REAGENTS

Applicant Gamma Enterprises, Inc.

K-Number K790578

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CFJ 1979-05-15

LD-P REAGENT (LDH P-L REAGENT)

Applicant Gilford Diagnostics

K-Number K790771

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JEW 1979-05-15

ASSAY REAGENTS, LSA 290

Applicant Kallestad Laboratories, Inc.

K-Number K790588

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