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

FRN 1983-03-31

WINDSOR MEDICAL, INC. 50-01-028

Applicant Windsor Medical, Inc.

K-Number K830544

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GAX 1983-03-31

TOURNIQUET/LATEX TOURNIQUET

Applicant Primeline Industries, Inc.

K-Number K830467

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FMF 1983-03-31

SUBCLAVIAN INSERTION KIT

Applicant Cunningham Woodland, Inc.

K-Number K823527

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CAE 1983-03-31

WILLIAMS AIRWAY INTUBATOR

Applicant Williams Airway Intubator

K-Number K830767

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N/A 1983-03-31

MEDICATED ADHESIVE STRIP

Applicant Cederroth, Inc. USA

K-Number K823057

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LIF 1983-03-31

RENALIN (TENTATIVE

Applicant Renal Systems, Inc.

K-Number K830575

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DSF 1983-03-31

DUAL CHANNEL RECORDER #78574A

Applicant Hewlett-Packard Co.

K-Number K830315

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DXN 1983-03-31

AMBULATORY BLOOD PRESSURE MONITOR

Applicant Vita-Stat Medical Services, Inc.

K-Number K830368

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FRN 1983-03-31

PUMP PALL AMBULATORY INSULIN INFUSION

Applicant Biomedical Devices, Inc.

K-Number K830605

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LKH 1983-03-31

COMBION SKIN TEST

Applicant Nicholas H. Maganias

K-Number K830688

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DWL 1983-03-31

VENES ANTI EMBOLISM STOCKINGS

Applicant Futuro Div. Jung Corp.

K-Number K830696

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HIS 1983-03-31

PRIME

Applicant Ansell, Inc.

K-Number K830691

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