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

GKL 1978-06-28

SYSTEM AUTO. BLOOD CELL COUNTER CC-110

Applicant Toa Medical Electronics USA, Inc.

K-Number K780910

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KPQ 1978-06-27

X-RAY SYSTEM

Applicant General X-Ray, Inc.

K-Number K780963

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HEM 1978-06-27

ULTRASONIC IMAGER

Applicant Air-Shields, Inc.

K-Number K780876

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IYX 1978-06-27

GAMMA CAMERA

Applicant Machlett Laboratories, Inc.

K-Number K780969

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IZL 1978-06-27

X-RAY FRAME HOLDER

Applicant Great Eastern Lumber Co., Inc.

K-Number K780999

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GKR 1978-06-22

SYSING AND HEMOGLOBIN REAGENT

Applicant Harleco

K-Number K780829

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GDW 1978-06-22

AUTO SUTURE DISPOSABLE STAPLING INSTRU.

Applicant United States Surgical, A Division of Tyco Healthc

K-Number K780695

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GBX 1978-06-22

IRRIGATION CATHETER

Applicant Shiley, Inc.

K-Number K780788

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FXX 1978-06-22

MASK, SURGEONS

Applicant Abco Dealers, Inc.

K-Number K780607

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JJJ 1978-06-22

IDI 200 GAMMA COUNTER

Applicant Iso-Data, Inc.

K-Number K780790

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GEI 1978-06-22

ELECTROSURGICAL GROUNDING PAD CABLE

Applicant Johnson & Johnson Professionals, Inc.

K-Number K780924

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IZF 1978-06-22

COMPUTERIZED AXIAL TOMOGRAPHY

Applicant Emi Medical, Inc.

K-Number K780995

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