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

KLK 1982-08-16

CRITIKON OXYGEN MONITOR, MODEL 8030

Applicant Critikon Company, LLC

K-Number K821936

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KDC 1982-08-16

KAM SUCKER

Applicant The Anspach Effort, Inc.

K-Number K822065

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JYE 1982-08-16

ENT CHISELS

Applicant Kelleher Corp.

K-Number K822165

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GXY 1982-08-16

EMPI SINGLE USE

Applicant Empi

K-Number K822224

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FLL 1982-08-16

EXACON THERMOMETER SYSTEM 8000

Applicant Sat Export Engineering & Trading

K-Number K821555

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KBJ 1982-08-16

BECKMAN ADENOID CURRETTE

Applicant Kelleher Corp.

K-Number K822189

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KAD 1982-08-16

VARIOUS TYPES OF ENT ELEVATORS

Applicant Kelleher Corp.

K-Number K822270

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LEH 1982-08-16

VANCOMYCIN FLUORESCENT IMMUNOASSAY

Applicant American Diagnostic Corp.

K-Number K822308

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FJH 1982-08-12

CF 1211 CAPILLARY FLOW DIALYZER CODE

Applicant Travenol Laboratories, S.A.

K-Number K822395

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JPZ 1982-08-12

GILCHEM Y-GT REAGENT

Applicant Gilford Diagnostics

K-Number K822149

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JES 1982-08-12

TOM'S NATURALLY WAXED FLOSSING TAPE

Applicant Tom'S of Maine, Inc.

K-Number K821685

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ESD 1982-08-12

DANAVOS CUSTOM EAR

Applicant Deravox, Inc.

K-Number K821991

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