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

DYB 1983-04-28

CORONARY GUIDING CATHETER

Applicant Advanced Cardiovascular Systems, Inc.

K-Number K830829

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JSM 1983-04-28

P & T MEDIUM

Applicant American Micro Scan

K-Number K831059

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JDO 1983-04-28

COMPRESSION SYSTEM

Applicant Kirschner Medical Corp.

K-Number K831076

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N/A 1983-04-28

DIGIRAD CFR 2000 RADIOGRAPHIC FILM CASSETTE

Applicant Digirad Corp.

K-Number K828562

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LDD 1983-04-28

DEFIBRILLATOR VPD 545

Applicant Life Science Instrumentation, Inc.

K-Number K831056

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LDD 1983-04-28

VPD540 DEFIBRILLATOR

Applicant Life Science Instrumentation, Inc.

K-Number K822617

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HLX 1983-04-28

CONTRAST SENSITIVITY EQUIPMENT

Applicant Cadwell Laboratories, Inc.

K-Number K830770

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KNX 1983-04-28

MALE EXTERNAL CATHETER

Applicant Post Medical, Inc.

K-Number K830946

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FPA 1983-04-28

I.V. SETS WALRUS BRAND VARIOUS CONFIGUR-

Applicant Medical Parameters, Inc.

K-Number K830755

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FPA 1983-04-28

MINI-VOL EXTENSION SET

Applicant Beech Medical, Inc.

K-Number K831087

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OCZ 1983-04-28

LOOP RETRIEVER

Applicant Van-Tec, Inc.

K-Number K830802

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EMA 1983-04-28

DENTA PLAST

Applicant Denta, Inc.

K-Number K830440

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