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

JSM 1982-11-16

CHLAMYDIA TRANSETTEE 1 & 3

Applicant Spectrum Co.

K-Number K823179

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DDB 1982-11-16

QUANTIMETRIC 2 CERULOPLASMIN ASSAY

Applicant Kallestad Laboratories, Inc.

K-Number K823107

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JSF 1982-11-16

MACATE BROTH

Applicant Granite Diagnostics, Inc.

K-Number K823000

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N/A 1982-11-16

CHANNEL BACK

Applicant J.G. Shuman Assoc.

K-Number K823093

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JIT 1982-11-16

KM - KAL 1

Applicant Kmn Products, Inc.

K-Number K823024

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ITI 1982-11-16

HITCH HIKER

Applicant Amigo Sales, Inc.

K-Number K823117

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KRZ 1982-11-16

CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT

Applicant Interscience, Inc.

K-Number K822327

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GZJ 1982-11-16

THE EMD TENZ PAIN CONTROL SYSTEM

Applicant Electro Medical Development

K-Number K822841

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JIT 1982-11-16

KM-KAL L6

Applicant Kmn Products, Inc.

K-Number K823023

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JTC 1982-11-16

DISPOSABLE DISPENSE MANIFOLD

Applicant Dynatech Laboratories, Inc.

K-Number K823218

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ITI 1982-11-16

SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER

Applicant Kinetic Concepts, Inc.

K-Number K823175

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BZK 1982-11-16

BEAR VM-90 VENTILATION MONITOR

Applicant Bear Medical Systems, Inc.

K-Number K822912

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