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

DXY 1980-09-09

MEDTRONIC MODEL 2409

Applicant Medtronic Vascular

K-Number K800226

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EIA 1980-09-09

LITTLE GIANT I & II HANDPIECE CONTROL

Applicant Silverman'S

K-Number K801975

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N/A 1980-09-09

BREAKING CAST WIRE CAT.#1112-1115

Applicant Pollak (Intl.), Ltd.

K-Number K802008

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FAE 1980-09-09

AMS MALLEABLE OR JONAS SILICONE-SILVER

Applicant American Medical Systems, Inc.

K-Number K792724

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DXY 1980-09-09

BATTERY FOR #229-01 PULSE GENERATOR

Applicant Intermedics, Inc.

K-Number K802040

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BTO 1980-09-09

CUFFED TRACHEA TUBE FOR USE W/PERTRACH

Applicant Frederic J. Toye, M.D.

K-Number K801379

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JYJ 1980-09-09

RHINOMETER

Applicant Aztec Medical Products, Inc.

K-Number K801938

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HXK 1980-09-09

ACE FISCHER EXTERNAL FIXATION DEVICE

Applicant Ace Orthopedic Manufacturing Co.

K-Number K801594

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FSO 1980-09-09

VOCON MODEL VC526

Applicant Teknar, Inc.

K-Number K801314

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JSP 1980-09-09

TEST PANEL FOR PRESUMP. ID/BACT. ORG

Applicant Micro-Media Systems, Inc.

K-Number K801547

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CDL 1980-09-09

DATA-ZYME UREA NITROGEN, COLORIMETRIC

Applicant Data Medical Associates, Inc.

K-Number K801727

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FMC 1980-09-09

STERILE EXAMINATION GLOVE #5121-5126

Applicant Pollak (Intl.), Ltd.

K-Number K801998

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