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

BYX 1980-06-04

DISPOSABLE PRESSURE LINE ADAPTOR

Applicant Intec Medical, Inc.

K-Number K801260

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IPF 1980-06-04

PULSED GALVANIC STIMULATOR, 450-DYNAMAX

Applicant U.S. Medical Corp.

K-Number K801053

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BXX 1980-06-04

NEEDLE COUNTER-SURE COUNT/10 COUNT

Applicant Kleen Test Products

K-Number K801258

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BTT 1980-06-04

NEBULIZER WITH AIR ENTERTAINER & ETC.

Applicant Airlife, Inc.

K-Number K801252

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EMA 1980-06-04

BONDALCAP (CARBOXYLATE)

Applicant Vivadent (Usa), Inc.

K-Number K801229

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DTZ 1980-06-04

BUILT-IN TEMPERATURE MONITORING

Applicant Bentley Laboratories, Inc.

K-Number K801240

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LEJ 1980-06-04

SUNTANA SUNBED #SB-1 & SUNBRELLA #SU-1

Applicant Sun Ind., Inc.

K-Number K800744

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DXN 1980-06-04

TONOTEST BLOOD PRESSURE MONITOR

Applicant Retlif, Inc.

K-Number K800904

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DXY 1980-06-04

ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN.

Applicant Arco Medical Products Co.

K-Number K800838

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HQP 1980-06-04

PERFECTEMP OPHTHALMIC CAUTERY

Applicant Medical Products Development, Inc.

K-Number K801078

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LDE 1980-06-04

CONPHAR SPRAGUE RAPPAPORT STETHOSCOPE

Applicant Conphar, Inc.

K-Number K801184

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N/A 1980-06-04

SUN SCENE TAN BOOTH

Applicant Sun Scene International, Inc.

K-Number K800592

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