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

N/A 1983-01-24

MODEL ML-4000 OPHTHALMIC LASER WITH FIBER OPTIC DELIVERY SYSTEM

Applicant Meditec, Inc.

K-Number K837030

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DSP 1983-01-24

PERCOR INTRA-AORTIC BALLOON INSERTION

Applicant Datascope Corp.

K-Number K823342

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N/A 1983-01-24

VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER

Applicant Randwal Instrument Co., Inc.

K-Number K827577

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JHI 1983-01-24

GENESIS B-HCG

Applicant Armkel, LLC

K-Number K823753

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HGY 1983-01-24

MEDELA NAMUAL BREAST PUMP

Applicant Medela, Inc.

K-Number K823840

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KWH 1983-01-24

ZIMMER GREAT TOE

Applicant Zimmer, Inc.

K-Number K823405

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HDB 1983-01-24

MEDELA SUCTION PUMP

Applicant Medela, Inc.

K-Number K830012

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JDI 1983-01-21

SPECTRON PROTRUSIO CUP

Applicant Richard'S Medical Equip., Inc.

K-Number K823725

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ILT 1983-01-21

CARD HOLDER FOR QUADS

Applicant Fred Sammons, Inc.

K-Number K823657

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JKA 1983-01-21

MONOJECT SAMPLETTE CAPILLARY BLOOD COLL

Applicant Sherwood Medical Co.

K-Number K823836

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KNP 1983-01-21

SLIP-ON SANDALS FOR MEASURING SHORTNESS

Applicant Fred Sammons, Inc.

K-Number K823654

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IME 1983-01-21

THERMOELASTOMER HOT/COLD COMPRESS BK7186

Applicant Fred Sammons, Inc.

K-Number K823649

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