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

EJK 1980-11-12

REOLIT

Applicant Vivadent (Usa), Inc.

K-Number K802685

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KDC 1980-11-12

SI-14

Applicant Kmi Medical, Inc.

K-Number K801908

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EAY 1980-11-12

DEN-MAT FIBER OPTIC HALOGEN LIGHT

Applicant Den-Mat Corp.

K-Number K802716

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ETD 1980-11-12

OTOLOGICAL VENTILATION TUBES

Applicant Santa Barbara Medco, Inc.

K-Number K802638

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FMC 1980-11-12

SUTURE WOUND TRAY MILFORD WHITTINSVILLE

Applicant American Medical Disposable, Inc.

K-Number K802386

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DRX 1980-11-12

EXTERNAL JUGULAR CVP CATHERIZATION KIT

Applicant Willson

K-Number K802576

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GXI 1980-11-12

VAXIOM FAMILY OF RF LESION PROBES & ELEC

Applicant Progress Mankind Technology

K-Number K802243

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EWO 1980-11-12

TINNITUS RESEARCH AUDIOMETER

Applicant Starkey Laboratories, Inc.

K-Number K802560

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IGG 1980-11-12

PLEASCENT OR FORMA-SCENT

Applicant Meridian Diagnostics, Inc.

K-Number K802506

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FXX 1980-11-12

SURGICAL FACE MASK

Applicant Louis M. Gerson Co., Inc.

K-Number K802373

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HKX 1980-11-12

AO NON-CONTACT II TONOMETER

Applicant American Optical Corp.

K-Number K802419

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KNX 1980-11-12

URINARY DRAINAGE UNT

Applicant Diamed Division Ill. Tool Works, Inc.

K-Number K802664

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