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

CAW 1981-05-05

MODEL RXO2 OXYGEN RICH AIR SUPPLY

Applicant Greene & Kellogg, Inc.

K-Number K811155

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JSG 1981-05-05

FLUID THIOGLYCOLLATE MEDIUM

Applicant Acumedia Manufacturers, Inc.

K-Number K811047

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JSI 1981-05-05

HEKTOEN ENTERIC AGAR

Applicant Acumedia Manufacturers, Inc.

K-Number K811131

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FJG 1981-05-05

CYBER 80 HEMODIALYZER

Applicant Cyberex Corp.

K-Number K810837

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JSI 1981-05-05

XLD AGAR

Applicant Acumedia Manufacturers, Inc.

K-Number K811042

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GPT 1981-05-05

DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT

Applicant Bartels Immunodiagnostic Supplies, Inc.

K-Number K810856

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ELC 1981-05-05

ROOT CANAL KIT

Applicant Dentsply Intl.

K-Number K811023

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BTO 1981-05-05

MONTGOMERY SILICONE TRACHEAL T-TUBE

Applicant Boston Medical Products, Inc.

K-Number K810978

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HAM 1981-05-01

NDM DIATEMP INFANT ELECTROSURG. DISP. P.

Applicant Ndm Corp.

K-Number K810920

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DBE 1981-05-01

ANTISMOOTH MUSCLE ANTIBODY TEST SYS

Applicant Immuno-Products Industries

K-Number K810983

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N/A 1981-05-01

POLYETHYLENE MEDULLARY PLUG

Applicant Arthur A. Checchi, Inc.

K-Number K811060

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JSG 1981-05-01

TRYPTIC SOY AGAR W/LECITHIN & TWEEN 80

Applicant Acumedia Manufacturers, Inc.

K-Number K811052

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