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

JTO 1982-02-04

RAPID STREP

Applicant Dms Laboratories

K-Number K813610

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HQE 1982-02-04

ULTRASONIC FRAGMENTOR

Applicant Fibra Sonics, Inc.

K-Number K813389

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KGX 1982-02-04

COMFEEL PROTECTIVE SHEET

Applicant Telecam Medical Devices

K-Number K820018

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JWX 1982-02-04

STAPH TRAC

Applicant Dms Laboratories

K-Number K813614

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ITG 1982-02-04

ULTRACAST WATERLESS SYNTHETIC RESIN CAST

Applicant Zimmer, Inc.

K-Number K813052

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JSC 1982-02-04

CHL

Applicant Dms Laboratories

K-Number K813615

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JCM 1982-02-04

SICKLE-CHECK

Applicant Diagnostic Technology, Inc.

K-Number K820037

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GAZ 1982-02-04

PLEUROFIX THORACENTESIS KIT

Applicant Burron Medical Products, Inc.

K-Number K820004

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HZJ 1982-02-04

MODIFIED EA 50

Applicant Surgipath

K-Number K820027

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NAB 1982-02-04

TONSIL SPONGES

Applicant Stan-Pak Ent.

K-Number K820095

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KSA 1982-02-04

HEMATOLOGY CALIBRATOR S-CAL

Applicant Coulter Electronics, Inc.

K-Number K813375

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NAB 1982-02-04

ROLLER GAUZE

Applicant Stan-Pak Ent.

K-Number K820098

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