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

KRZ 1983-07-28

CALIBRATION STANDARD-HEMOGLOBIN

Applicant United Diagnostics, Inc.

K-Number K831814

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GWF 1983-07-28

COMPACT FOUR

Applicant Nicolet Biomedical Instruments

K-Number K831896

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IEO 1983-07-28

TISSUE-TEK V.I.P. 100/200

Applicant Miles Laboratories, Inc.

K-Number K831313

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EIH 1983-07-28

SAVE-A-BAKE PORCELAIN POLISH

Applicant Denpac Corp.

K-Number K831483

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PPM 1983-07-28

SODIUM HYPOCHLORITE 3%

Applicant Omega Medical Diagnostics

K-Number K831620

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JCY 1983-07-28

SILCATH CENTRAL CATHETER TRAY W/18 GA

Applicant Argon Medical Corp.

K-Number K831453

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FLE 1983-07-27

PORTABLE AUTOCLAVES

Applicant Arnold & Sons

K-Number K830931

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EBH 1983-07-26

SOLARCRYL CUSTOM TRAY MATERIAL

Applicant Solar Dental Co., Inc.

K-Number K831293

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FAH 1983-07-26

COAXIAL BALLOON URETHRAL DILATOR

Applicant Thomas J. Fogarty, M.D.

K-Number K831384

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LIB 1983-07-26

MICROELISA COMP

Applicant Organon Teknika Corp.

K-Number K831658

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EFQ 1983-07-26

GAUZE CONVERSION CLASS I-NON-STERILE

Applicant Winn Hirsch & Assoc.

K-Number K832214

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EKA 1983-07-26

FR ROOT CANAL SEALER

Applicant Shizai Corp.

K-Number K830764

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