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

FTC 1981-10-13

SUNLAMP

Applicant The Richmond Light Co.

K-Number K812446

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IYM 1981-10-13

ORTHO-THERM INFRARED SENSOR

Applicant Orthion Corp.

K-Number K812701

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DYB 1981-10-13

IMPLANTAID LEAD INTRODUCER #319-10 & 12

Applicant Intermedics, Inc.

K-Number K812502

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DXY 1981-10-13

KALOS-03

Applicant Biotronik Sales, Inc.

K-Number K812218

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FMF 1981-10-09

MDM ARTERIAL BLOOD GAS SYRINGE

Applicant Martell Medical Products, Inc.

K-Number K812560

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CFH 1981-10-09

LDH REAGENT SET

Applicant Anco Medical Reagents & Assoc.

K-Number K812836

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CIC 1981-10-09

TOTAL CALCIUM REAGENT SET

Applicant Anco Medical Reagents & Assoc.

K-Number K812835

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CAK 1981-10-08

HEMA 20 MICRON TRANSFUSION BLOOD FILTER

Applicant Abbott Laboratories

K-Number K812697

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FOH 1981-10-08

ADULT FLEXFLOAT

Applicant Pharmaquest Corp.

K-Number K812684

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GZB 1981-10-08

MEDTRONIC DUAL CHANNEL SPINAL CORD STIM

Applicant Medtronic Vascular

K-Number K812155

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JBQ 1981-10-08

ACA ANTITHROMBIN III TEST PACK

Applicant E.I. Dupont DE Nemours & Co., Inc.

K-Number K812627

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FTC 1981-10-08

SUNTANNING HOME UNIT

Applicant Tannhut

K-Number K812579

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