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

CZW 1983-04-05

FIAX COMPLEMENT C3 TEST KIT

Applicant Intl. Diagnostic Technology

K-Number K830668

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CHD 1983-04-05

ACTIVATED URIC ACID

Applicant American Monitor Corp.

K-Number K830616

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GJS 1983-04-05

LIQUID THROMBOPLASTIN REAGENT

Applicant Helena Laboratories

K-Number K830331

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HQZ 1983-04-05

HANDPIECE SYSTEM I/A

Applicant Uxtra Corp.

K-Number K830413

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ILE 1983-04-05

OB HELP ARM

Applicant Lic-Orthion

K-Number K830842

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HQC 1983-04-05

IV STAND

Applicant Teknar, Inc.

K-Number K830474

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N/A 1983-04-04

MULTI-USER IMAGING AND ACQUISITION TERMINALS

Applicant Computer Design & Applications, Inc.

K-Number K837213

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N/A 1983-04-04

NOVO BMC LAB 22A BONE MINERAL CONTENT DETERMINATION IN THE AXIAL SKELETON

Applicant Novo Diagnostic Systems

K-Number K828574

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N/A 1983-04-04

BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEM

Applicant Biosound, Inc.

K-Number K837063

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N/A 1983-04-04

MODEL 920 ARGON LASER SYSTEM

Applicant Coherent Radiation Laboratories

K-Number K837235

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N/A 1983-04-04

MODEL XA-15 LASER SYSTEM FOR SURGERY

Applicant Xanar, Inc.

K-Number K837216

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N/A 1983-04-04

BRITT SURGICAL PHOTOCOAGULATOR SYSTEM

Applicant Britt Corp., Inc.

K-Number K837200

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