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

DSP 1983-02-18

INTRA-AORTIC BALLOON SYSTEM

Applicant Smec, Inc.

K-Number K823739

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EFN 1983-02-18

STERILE COTTON ROLLS #3, 1 1/2

Applicant Veratex Corp.

K-Number K830175

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EMA 1983-02-18

SELFAST

Applicant North Pacific Dental, Inc.

K-Number K830107

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N/A 1983-02-18

SUTURE NEEDLES

Applicant Feuerstein Produktions

K-Number K823229

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N/A 1983-02-17

EXPANDED PTFE PROSTHESIS BLOOD ACCES

Applicant C.R. Bard, Inc.

K-Number K823748

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CAW 1983-02-17

DE VO/44 OXYGEN CONCENTRATOR #444

Applicant The Devilbiss Co.

K-Number K830174

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KOC 1983-02-16

KF-101-07 DIALYZER

Applicant Extracorporeal Medical Specialities, Inc.

K-Number K822337

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KOC 1983-02-16

KF-101-10 DIALYZER

Applicant Extracorporeal Medical Specialities, Inc.

K-Number K822338

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LHL 1983-02-16

DIRECT FA CONJUGATE FOR LEGIONELLA SPP

Applicant Zeus Technologies

K-Number K822859

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KOC 1983-02-16

KF-101-13 DIALYZER

Applicant Extracorporeal Medical Specialities, Inc.

K-Number K822339

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LBI 1983-02-16

MICROELISA MINIREADER II

Applicant Dynatech Corp.

K-Number K830200

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FFX 1983-02-15

MOTILITY CATHETERS

Applicant Mui Scientific

K-Number K823701

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