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

DHX 1980-09-26

CLINETICS PCA COLUMN

Applicant Clinetics Corp.

K-Number K801306

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JQW 1980-09-26

MICROLAB M-MICROPROCESSOR DILUTER/DISP

Applicant Hamilton Co.

K-Number K801913

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GJA 1980-09-26

FIBRI QUIK

Applicant General Diagnostics

K-Number K802117

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FMZ 1980-09-26

ISOLETTE INCUBATOR C-100

Applicant Narco Air-Shields

K-Number K802126

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FJI 1980-09-26

RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D.

Applicant Renal Systems, Inc.

K-Number K801825

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LCP 1980-09-26

HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH

Applicant Helena Laboratories

K-Number K800857

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ELW 1980-09-26

DENTLOID

Applicant U.S. Shizai Corp.

K-Number K802189

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DSI 1980-09-26

ECG RECALL & EDIT PRODUCT VERSION-A3601

Applicant General Electric Co.

K-Number K802103

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LBW 1980-09-26

HEMOCATH I KIDNEY DIALYSIS CATHETER

Applicant Medical Components, Inc.

K-Number K801968

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KGX 1980-09-26

3M HI-STRENGTH MED. TAPE #1534

Applicant 3M Company

K-Number K802242

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BTT 1980-09-26

2C 7140 HEATED HUMIDIFER CANNISTER

Applicant Travenol Laboratories, S.A.

K-Number K802145

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IYN 1980-09-26

EDP 1200 SECTOR SCANNER OPTION

Applicant Unirad Corp.

K-Number K801656

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