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

GET 1983-08-12

HALL RECIPROCATOR

Applicant Amsco Co.

K-Number K832188

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JGX 1983-08-12

LIPASE REAGENT SET

Applicant Sterling Biochemical, Inc.

K-Number K831874

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DJY 1983-08-12

HC40/HC75 PREPACKED COLUMS

Applicant Hamilton Co.

K-Number K832198

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DTB 1983-08-12

UNIPOLAR-E ENDOCARDIAL TINED LEAD

Applicant Cook Pacemaker Corp.

K-Number K832245

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JGS 1983-08-12

AMRESCO NA/K REAGENT SET

Applicant American Research Products Co.

K-Number K832070

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JJW 1983-08-12

URINE TOTAL PROTEIN CONTROL

Applicant Quantimetrix Corp.

K-Number K831526

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EFQ 1983-08-12

GAUZE SPONGE NON-STERILE

Applicant Sudreca Surgical Dressings, Inc.

K-Number K832174

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FRO 1983-08-12

GELIPERM GRANULES

Applicant Geistlich-Pharma

K-Number K823225

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FRN 1983-08-12

INFUTROL 7000 INFUSION PUMP

Applicant Valleylab, Inc.

K-Number K832008

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HAO 1983-08-12

DERMALAND DURAL HOOKS

Applicant National Fabtronix, Inc.

K-Number K832343

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HQE 1983-08-12

BAILEY ASPIRATOR/IRRIGATOR

Applicant Medical Instrument Development Laboratories, Inc.

K-Number K831584

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BTM 1983-08-12

SC-603 TWIN VALVE

Applicant Instrumentation Industries, Inc.

K-Number K831486

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