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

DPS 1980-08-07

ELECTROCARDIOGRAPH, MODEL ECG-5503

Applicant Nihon Kohden America, Inc.

K-Number K801677

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IQI 1980-08-07

HUMEROUS FRACTURE BRACE, ULNA FRACTURE

Applicant Hosmer Dorrance Corp.

K-Number K801788

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DXH 1980-08-07

UNI-RECORD I

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K801700

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ILH 1980-08-07

TRANS DISTAL JOINT FINGER EXTEN. SPLINT

Applicant Fred Sammons, Inc.

K-Number K801714

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FTG 1980-08-07

NIKKISO PARALLEL FLOW DIALYZERS

Applicant Int'L Marketing & Sales Corp.

K-Number K801065

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ION 1980-08-07

BK-5315-01 FOAM HAND EXERCISER, SMALL

Applicant Fred Sammons, Inc.

K-Number K801710

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ILC 1980-08-07

BK-1426-00-01 STONYBROOK/HI-WALL PLATE

Applicant Fred Sammons, Inc.

K-Number K801706

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KNP 1980-08-07

PLASTAZOTE SHOE

Applicant Alimed, Inc.

K-Number K801743

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ILC 1980-08-07

BK-1424 INNER LIP PLATE, CERAMIC

Applicant Fred Sammons, Inc.

K-Number K801705

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KNO 1980-08-07

BK-5058-01 QUAD-QUIP WHEELCHAIR CUFF

Applicant Fred Sammons, Inc.

K-Number K801709

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DZN 1980-08-07

PALODENT MATRICES & BITINE RINGS

Applicant Alvin Meyer, D.D.S.

K-Number K801142

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IQI 1980-08-07

BK-1520-01 ECONOMY WRIST SUPPORT, CHILD

Applicant Fred Sammons, Inc.

K-Number K801708

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