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

DGC 1983-05-09

IGE-QUANT DIAGNOSTIC TEST KIT

Applicant Leeco Diagnostics, Inc.

K-Number K831208

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KNT 1983-05-09

ENTERAL DELIVERY SET

Applicant Biosearch Medical Products, Inc.

K-Number K831168

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BTR 1983-05-09

TRACHEAL TUBE W/ILLUMINATING LOCATER

Applicant Mallinckrodt Critical Care

K-Number K830631

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DRE 1983-05-09

VESSEL DILATOR

Applicant Medrad, Inc.

K-Number K831190

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ELB 1983-05-09

AIR BURBINE HANDPIECE-DENTAL SCALING

Applicant Taco Dental, Inc.

K-Number K831037

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DTB 1983-05-09

POROUS TIP ENDOCARDIAL LEAD

Applicant Daig Corp.

K-Number K830743

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BTK 1983-05-09

HEAD STRAP

Applicant Medovations, Inc.

K-Number K831008

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DOY 1983-05-09

VASCULAR CATHETER

Applicant Medrad, Inc.

K-Number K831191

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KLT 1983-05-09

CARBAMEZEPINE REAGENT TEST KIT

Applicant Beckman Instruments, Inc.

K-Number K831222

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FPA 1983-05-09

CUSTOM IV SET

Applicant Custom Medical, Inc.

K-Number K830182

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JDI 1983-05-09

HARRIS A.R. C. ACETABULAR CUP

Applicant Howmedica Corp.

K-Number K830857

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EMA 1983-05-09

SEPTOPACK

Applicant North Pacific Dental, Inc.

K-Number K830113

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