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

N/A 1983-01-07

LASER PHOTOCOAGULATOR

Applicant American Laser Corp.

K-Number K827819

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FAP 1983-01-07

URETHRAL PRESSURE PROFILE & TEMP. MODUL

Applicant Nihon Kohden America, Inc.

K-Number K823561

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JXA 1983-01-07

RAPID BACTERIURIA SCREENING TEST

Applicant Analytical Luminescence Laboratory, Inc.

K-Number K820126

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CAI 1983-01-07

DISPOSABLE NON-REBREATHING ANES. CIRCUIT

Applicant Marquest Medical Products, Inc.

K-Number K823714

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CIX 1983-01-07

COBAS STANDARDS FOR ALBUMIN

Applicant Hoffmann-La Roche, Inc.

K-Number K823575

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GZJ 1983-01-07

WRIGHT CARE

Applicant Dow Corning Wright

K-Number K823497

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KDI 1983-01-07

COBE HEMOCONCENTRATOR 1.3

Applicant Cobe Laboratories, Inc.

K-Number K823338

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HRQ 1983-01-07

VASCU-STATT APPROXIMATOR

Applicant Scanlan Intl., Inc.

K-Number K823694

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BSO 1983-01-07

EPIDURAL CATHETER

Applicant Rsp, Inc.

K-Number K823702

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LJG 1983-01-07

ATS GRAM STAIN CONTROL SLIDE

Applicant Alpha-Tec Systems, Inc.

K-Number K823704

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JTN 1983-01-07

AZLOCILLIN 75MCG SENSI-DISC

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K823800

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JHT 1983-01-07

CK-ISOZYME U.V. REAGENT SET

Applicant Gelman Sciences, Inc.

K-Number K823550

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