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

LCX 1978-04-04

PREGNANCY TEST KIT, OVER-THE-COUNTER

Applicant Intl. Diagnostic, Inc.

K-Number K780321

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CAN 1978-04-04

OXYGEN REGULATOR/FLOWMETER

Applicant Erie Mfg., Co.

K-Number K780359

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GWY 1978-04-04

PINWHEEL

Applicant Projects IN Health

K-Number K780422

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CAF 1978-04-03

NEBULIZER, DISP, 2D0815

Applicant Travenol Laboratories, S.A.

K-Number K780119

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KDD 1978-04-03

URINE SAMPLE KIT

Applicant American Hospital Supply Corp.

K-Number K780336

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IYW 1978-03-31

IMAGER, BODY SECTION, RADIONUCLIDE

Applicant Union Carbide Corp.

K-Number K780395

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FKQ 1978-03-31

DIALYZING FLUIDE DELIVERY SYSTEM

Applicant Travenol Laboratories, S.A.

K-Number K780081

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ESD 1978-03-30

CLEARTONE MODEL-1 & 2 HEARING AIDS

Applicant Cleartone Custom Hearing Instruments

K-Number K780459

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GJE 1978-03-30

AUTO ISO-FILTER COLLECTION TUBE CAP

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K780303

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CAM 1978-03-30

OXYGEN/NITROUS OXIDE OUTLET

Applicant Spica, Inc.

K-Number K780365

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CAN 1978-03-30

MANIFOLD KIT

Applicant Spica, Inc.

K-Number K780364

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JOZ 1978-03-30

SOLUBLE COLLAGEN

Applicant General Diagnostics

K-Number K780285

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