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

IOZ 1983-01-14

ABDUCTION PILLOW

Applicant Danek Medical, Inc.

K-Number K823820

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BZL 1983-01-14

CPM METABOLIC MONITOR

Applicant Medicor USA , Ltd.

K-Number K823695

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ILI 1983-01-14

A.C. SPLINT

Applicant Danek Medical, Inc.

K-Number K823810

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CCN 1983-01-14

BORDON GAGE REGULATOR #BG

Applicant Timeter Instrument Corp.

K-Number K823775

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KOC 1983-01-14

A.V. FISTULA CANNULATION SETS

Applicant Travenol Laboratories, S.A.

K-Number K830021

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IQI 1983-01-14

VARIOUS SUPPORTS AND SPLINTS

Applicant Danek Medical, Inc.

K-Number K823812

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JDI 1983-01-14

CEMENTLESS ZWEYMUELLER HIP ENDOPROTHES

Applicant Allo Pro Corp.

K-Number K822979

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DGC 1983-01-14

TOTAL IGE-FAST TEST

Applicant Axonics, Inc.

K-Number K823494

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KIC 1983-01-14

RUBBER INFLATABLE RING

Applicant Duro-Med Ind., Inc.

K-Number K823903

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LGF 1983-01-14

CAST TOE COVER

Applicant Danek Medical, Inc.

K-Number K823819

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GLQ 1983-01-14

CONTROL TM 8

Applicant General Diagnostics

K-Number K823794

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N/A 1983-01-14

COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100

Applicant Imatron, Inc.

K-Number K828669

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