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

JHI 1982-07-22

TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT

Applicant Hybritech, Inc.

K-Number K821944

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IYO 1982-07-22

OCULAR-BIOMETER 4000

Applicant Radionics, Inc.

K-Number K820042

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CGR 1982-07-22

ZETA-CORT

Applicant Amf Biological and Diagnostics Co.

K-Number K821931

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KNX 1982-07-22

U-100 BAG

Applicant Medical Technologies of Georgia

K-Number K821853

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N/A 1982-07-22

DELTASCAN HPS CT SCANNER

Applicant Technicare Corp.

K-Number K827644

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IPF 1982-07-22

P6S ATHLETIC

Applicant Squire, Sanders & Dempsey

K-Number K821449

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LDR 1982-07-21

SKIN SCRUB-TRAY

Applicant Associated Medical Products Co.

K-Number K821579

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GZJ 1982-07-21

TP440 ORTHOPROBE

Applicant Grove Video Corp.

K-Number K821571

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KDT 1982-07-21

PREGNOPOST

Applicant M.M. Wolfred, Ph.D.

K-Number K821621

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KOD 1982-07-21

DYNACOR URETHRAL CATHETER TRAY

Applicant Medline Industries, Inc.

K-Number K821970

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N/A 1982-07-20

MILBURN'S BACKEASER

Applicant The T. Milburn Co. , Ltd.

K-Number K821808

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CCX 1982-07-20

VARI-SUPPORT LOW BACK POSTURE PILLOW

Applicant Body Therapeutics, Inc.

K-Number K821838

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