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

DLF 1978-04-12

ANALYZER, FAST, CENTRIFUGAL, GEMSAEC

Applicant Syva Co.

K-Number K780380

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KCW 1978-04-12

THERMOLYSIS GENERATOR

Applicant Clare, Inc.

K-Number K780337

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CAF 1978-04-12

2C7153 NEBULIZER CAP

Applicant Travenol Laboratories, S.A.

K-Number K780406

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IQF 1978-04-12

SPINE BOARD

Applicant Marullo, Baldwin, Frieden, Gatewood,

K-Number K780489

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JQT 1978-04-12

MODULAR SCANNING DENSITOMETER SYS.

Applicant Transidyne General Corp.

K-Number K780318

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FRN 1978-04-10

INFUSION PUMP

Applicant Air-Shields, Inc.

K-Number K780503

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DQX 1978-04-10

ELECATH PLASTIC JACKETED GUIDEWIRE

Applicant Electro-Catheter Corp.

K-Number K780493

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FPY 1978-04-10

BURN DRESSING PAD

Applicant The Owenby Co.

K-Number K780418

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FPD 1978-04-10

VIVONEX DELIVERY SYSTEM

Applicant Norwich Pharmacal Co.

K-Number K780415

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FLL 1978-04-10

THERMOMETER, DIGITAL, NTM-100

Applicant Wilton Webster Laboratories

K-Number K780131

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FOG 1978-04-10

HOOD, INFANT OXYGEN

Applicant Shiley, Inc.

K-Number K780220

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FPA 1978-04-10

I.V. LEVER CLAMP

Applicant Travenol Laboratories, S.A.

K-Number K780481

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