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

CDP 1983-06-30

ISO-SEP SYSTEM

Applicant Berwick Medical Products, Inc.

K-Number K831434

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ERA 1983-06-30

AUDIOSCOPE #23000 W/71123 CHARGING STAND

Applicant Welch Allyn, Inc.

K-Number K831709

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EBC 1983-06-30

DELTON LIGHT CURING PIT & FISSURE

Applicant Johnson & Johnson Professionals, Inc.

K-Number K831380

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JHJ 1983-06-30

E.P.T. PLUS TM

Applicant Warner-Lambert Co.

K-Number K831535

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DIF 1983-06-30

TRI-LEVEL TDM CONTROL & I II III

Applicant Ortho Diagnostic Systems, Inc.

K-Number K831500

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DQY 1983-06-30

CORONARY GUIDING CATHETER-MODIFIED

Applicant Advanced Cardiovascular Systems, Inc.

K-Number K831563

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HRX 1983-06-30

ARTHROSCOPY KNIVES/PROBES/BENDING TOOL

Applicant Richards Manufacturer Co.

K-Number K831656

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FJK 1983-06-30

PLASMA THERAPY TUBESET-E100 SERIES

Applicant Parker Hannifin Corp.

K-Number K831747

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EFQ 1983-06-29

SUTURE KITS STERILIZED W/GAMA RADIATION

Applicant South Mountain Medical

K-Number K831806

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N/A 1983-06-28

SATURNE I LINEAR ACCELERATOR

Applicant Cgr Medical Corp.

K-Number K837412

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N/A 1983-06-28

UNKNOWN

Applicant Elscint, Inc.

K-Number K837355

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N/A 1983-06-28

ALCYON ROTATIONAL COBALT THERAPY

Applicant Cgr Medical Corp.

K-Number K837465

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