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

KPE 1983-03-01

DELMED IV CONTAINER

Applicant Delmed, Inc.

K-Number K830450

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LJT 1983-03-01

VASCULAR-ACCESS-PORT

Applicant Norfolk Medical Products, Inc.

K-Number K830000

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KMK 1983-03-01

FREHAN INC. I.V. FILTER HOLDER

Applicant Saxnor Corp.

K-Number K830300

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DGC 1983-03-01

DENSITOMETRIC INHALENT PROFILE SLLER

Applicant Mast Immunosystems

K-Number K830164

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JXA 1983-03-01

BAC-T-SCREEN BACTERIURIA DETECTION DEV

Applicant Marion Laboratories, Inc.

K-Number K823850

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FRN 1983-03-01

SECURA IV VOLUMETRIC INFUSION PUMP

Applicant Diatek, Inc.

K-Number K830355

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HSB 1983-03-01

INTRAMEDULLARY ROD

Applicant The Deca Co.

K-Number K830087

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GIF 1983-03-01

OSMOCEL +

Applicant Hematology Marketing Assoc.

K-Number K830188

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HWT 1983-03-01

3M OSTEOTOMY GUIDE

Applicant 3M Company

K-Number K830360

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EMR 1983-03-01

CIMPAT

Applicant North Pacific Dental, Inc.

K-Number K830109

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GZK 1983-03-01

TIGER PULSE

Applicant Bertone & Assoc.

K-Number K830325

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FPA 1983-03-01

PORT-LOCK

Applicant Norfolk Medical Products, Inc.

K-Number K823845

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