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

GKL 1978-10-27

HEMO-W SYSTEM

Applicant Coulter Electronics, Inc.

K-Number K781628

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JHS 1978-10-27

L-CYSTEINE HYDROCHLORIDE

Applicant Fisher Scientific Co., LLC

K-Number K781690

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FLI 1978-10-27

CASTLE MODEL 3146 GAS AERATOR

Applicant Castle Co.

K-Number K781484

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FLN 1978-10-27

MONITOR, GRAVITY IRRIGATION DRIP

Applicant Syntel, Inc.

K-Number K781717

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IQF 1978-10-27

KENDRICK EXTRICATION DEVICE

Applicant Medi-Ked, Inc.

K-Number K781761

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JKA 1978-10-27

SERI-SEP SERUM/PLASMA ISLOLATOR

Applicant Wako Intl., Inc.

K-Number K781629

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JQW 1978-10-27

AUTODILUTER 2

Applicant Dynatech Laboratories, Inc.

K-Number K781645

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DTB 1978-10-27

PACING LEADS MODEL UL-811 AND UL-813

Applicant Pacesetter Systems

K-Number K781776

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JQW 1978-10-27

SRD-2

Applicant Dynatech Laboratories, Inc.

K-Number K781646

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DSB 1978-10-27

STRAIN GAUGE PLETHYSMOGRAPH

Applicant Medimatic

K-Number K781352

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CEP 1978-10-27

RIA KIT, LH

Applicant Amersham Corp.

K-Number K781685

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CAC 1978-10-26

TRAUMA DRAINAGE SET 72T-28TTC

Applicant Sorensen Research

K-Number K781550

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