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

BZK 1983-03-07

RESPITRACE SYSTEM

Applicant Respitrace Corp.

K-Number K823782

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JJE 1983-03-07

PARAMAX ANALYTICAL SYS

Applicant American Dade

K-Number K830318

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N/A 1983-03-04

SYSTEM 900 TWO ROOM REMOTE FIBERS

Applicant Coherent Radiation Laboratories

K-Number K837125

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N/A 1983-03-04

UNKNOWN

Applicant Lasertek OY

K-Number K828326

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N/A 1983-03-04

MODELS EUROSUN 2400 AND 800

Applicant Eurosun Scaenda Sol

K-Number K837139

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N/A 1983-03-03

ULTRASCAN DIGITAL A/SYSTEM III

Applicant Cooper Lasersonics, Inc.

K-Number K828328

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KDI 1983-03-02

FH 101, FH 202 & FH 303 FIBER HEMOFILTER

Applicant Gambro, Inc.

K-Number K830284

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GZT 1983-03-02

BUDDE-HALO RETRACTOR

Applicant Ohio Medical Instrument Co., Inc.

K-Number K830332

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GTZ 1983-03-01

ABBOTT LABORATORIES STREP A EIA

Applicant Abbott Laboratories

K-Number K823569

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LJS 1983-03-01

NON-STERILE BROVIAC PARENTERAL ALIMI-

Applicant Evermed, Inc.

K-Number K830256

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EKM 1983-03-01

GUTTA PERCHA POINTS

Applicant North Pacific Dental, Inc.

K-Number K830114

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EMA 1983-03-01

ENDOMET

Applicant North Pacific Dental, Inc.

K-Number K830117

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