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

CAZ 1980-09-16

ARROW POSITIVE PLACEMENT CON/EPIDURAL AN

Applicant Arrow Intl., Inc.

K-Number K801912

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ELC 1980-09-16

SONATRON ULTRASONIC DENTAL SCANNER

Applicant Simplified Systems, Inc.

K-Number K801689

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BZQ 1980-09-16

PDS MODEL 3000 ADULT RESPIRATION MODULE

Applicant General Electric Co.

K-Number K802046

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DXY 1980-09-16

SIEMENS-ELEMA PULSE GENERATOR 625

Applicant Siemens Elema AB

K-Number K801508

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GCX 1980-09-16

ARGYLE COMPACT CHEST DRAINAGE SYSTEM

Applicant Sherwood Medical Co.

K-Number K801979

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CKA 1980-09-16

DATA-ZYME LAT(GPT) PROCEDURE

Applicant Data Medical Associates, Inc.

K-Number K801857

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NAB 1980-09-16

GUAZE BANDAGES CAT.#101-169

Applicant Pollak (Intl.), Ltd.

K-Number K801996

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JTO 1980-09-16

BACITRACIN DIFFERENTIATION DISC

Applicant Biomedia, Inc.

K-Number K802127

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CDT 1980-09-16

WAKO TRIGLYCERIDE-G TEST

Applicant Wako Pure Chemical Industries, Ltd.

K-Number K801891

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EQL 1980-09-16

PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A

Applicant Pentax Precision Instrument Corp.

K-Number K801866

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N/A 1980-09-16

TISSUE-TEK III TISSUE EMBEDDING CENTER

Applicant Miles Laboratories, Inc.

K-Number K801956

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DWS 1980-09-16

DEKNATEL GOOSEN VASCULAR PUNCH BLADES

Applicant Howmedica Corp.

K-Number K802079

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