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

DXG 1980-11-24

NARCO AIR-SHEILDS SYS. 100 MONITOR SYS

Applicant Narco Air-Shields

K-Number K802800

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EBF 1980-11-24

HELIOSIT

Applicant Vivadent (Usa), Inc.

K-Number K802683

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FAP 1980-11-24

ROBERTSON OBTURATION MONITOR INSUFFLA

Applicant Endotek Corp.

K-Number K802374

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KGX 1980-11-24

PLASTIC ADHESIVE BANDAGE

Applicant Dyn-A-Med Products

K-Number K802764

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CDX 1980-11-24

SERUM T4 BY ENZYME IMMUNOASSAY

Applicant Worthington Diagnostic Systems

K-Number K802573

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EMA 1980-11-24

KETAC-CEM IN REF. TO K802048

Applicant Espe Dental Products

K-Number K802819

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LCR 1980-11-24

CYBREX TOBRAMYCIN

Applicant Abbott Laboratories

K-Number K802668

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DIF 1980-11-24

IN VITRO DIAGNOSTIC STANDARDS

Applicant Supelco, Inc.

K-Number K802278

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CCN 1980-11-21

VITAMIN B12 FOLATE RADIOASSAY

Applicant Corning Medical & Scientific

K-Number K802037

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DYG 1980-11-20

SWAN GANZ CATHETER PLACEMENT KIT

Applicant Stanco Medical, Inc.

K-Number K802288

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DQY 1980-11-20

RIGHT ATRIAL LINE KIT

Applicant Stanco Medical, Inc.

K-Number K802287

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HTT 1980-11-19

CARBIDE CUTTING INSTRUMENT/INTRAARTICU

Applicant The Anspach Effort, Inc.

K-Number K802598

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