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

JJX 1980-10-10

ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO

Applicant Beckman Instruments, Inc.

K-Number K802068

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KGO 1980-10-10

VIALON SURGEON'S GLOVES

Applicant Rivefain Corp.

K-Number K802027

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JHJ 1980-10-10

PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO

Applicant Intl. Diagnostic, Inc.

K-Number K802343

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KMS 1980-10-10

CO2 COLOR REAGENT & CO2 SAMPLE DILUENT

Applicant Panmed, Inc.

K-Number K802162

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N/A 1980-10-06

HYCEL TRIGYCERIDE II TEST

Applicant Hycel, Inc.

K-Number K802422

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IMD 1980-10-03

HOT CYCLE, A CHEMICAL TYPE HOT PACK

Applicant Signal West

K-Number K802252

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DRT 1980-10-03

CT-1600 DIGITAL PULSE RATE MONITOR

Applicant Industrial & Biomedical Sensors Corp.

K-Number K802204

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GWQ 1980-10-03

MINGOGRAF EEG10

Applicant Siemens Corp.

K-Number K802296

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DXC 1980-10-03

VESSEL RETRACTOR, #600732

Applicant Bentley Laboratories, Inc.

K-Number K802244

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KPX 1980-10-03

BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO

Applicant B C Medical , Ltd.

K-Number K801950

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BZC 1980-10-03

INFANT VENTILATORY MEASUREMENT SYSTEM

Applicant Medical Graphics Corp.

K-Number K801497

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DXY 1980-10-03

SORIN PULSE GENERATOR, MODEL #LIT-214

Applicant Bentley Laboratories, Inc.

K-Number K801640

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