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

GXB 1980-09-16

ALGESIOMETER

Applicant Rowan Products, Inc.

K-Number K801907

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LEJ 1980-09-16

RAMI ULTRAVIOLET A BOOTH

Applicant Rami-Tan

K-Number K801751

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GQN 1980-09-16

HSV BIO-BEAD TITRATION KIT

Applicant Litton Bionetics

K-Number K801721

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NAD 1980-09-16

PEDIBAND CAT.#195-197

Applicant Pollak (Intl.), Ltd.

K-Number K802021

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JJX 1980-09-16

SPINAL FLUID CONTROL(HUMAN)

Applicant Environmental Chemical Specialties

K-Number K801854

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JGS 1980-09-16

BECKMAN ELECTROLYTE-2 SODIUM/POTASSIUM

Applicant Beckman Instruments, Inc.

K-Number K801896

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KKX 1980-09-16

LAP SPONGES CAT.#801-850

Applicant Pollak (Intl.), Ltd.

K-Number K802001

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FLN 1980-09-16

I.V. SENTRY ALARM DEVICE

Applicant Pike Medical Co.

K-Number K802101

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CFT 1980-09-16

LACTI-QUANT

Applicant Nuclear Medical Laboratories, Inc.

K-Number K801849

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HQB 1980-09-16

SLIT LAMP ATTACHMENT

Applicant Cavitron Corp.

K-Number K801877

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GOL 1980-09-16

ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES)

Applicant Flow Laboratories, Inc.

K-Number K801098

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HOE 1980-09-16

BLEPHAROMETER

Applicant Aztec Medical Products, Inc.

K-Number K801937

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