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

LCP 1981-09-16

GLYCOHEMOGLOBIN

Applicant Macomb Chemical Co.

K-Number K810958

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LCP 1981-09-16

ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S

Applicant Ortho Diagnostic Systems, Inc.

K-Number K811567

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KZL 1981-09-16

CIRCULATING CYTO-THERMS

Applicant Cryosan, Inc.

K-Number K812311

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FRN 1981-09-16

3M INFUSION SYSTEM

Applicant 3M Company

K-Number K812442

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GES 1981-09-16

MICRO BLADE II

Applicant Vxtra Corp.

K-Number K812526

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DSY 1981-09-16

MANUFACTURING PROCESS CHANGE

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K-Number K811441

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DXZ 1981-09-16

GORE-TEX CARDIOVASCULAR PATCH

Applicant W. L. Gore & Associates, Inc.

K-Number K811841

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DRT 1981-09-16

CARDIACMONITORS

Applicant Pulse Time Products, Ltd.

K-Number K811425

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IDM 1981-09-16

LKB-BROMMA 2188 ULTROTOME NOVA

Applicant Lkb Instruments, Inc.

K-Number K812158

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FJI 1981-09-16

KF-E SERIES OF HOLLOW FIBER DIALYZERS

Applicant Medisystems Corp.

K-Number K812353

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GQH 1981-09-16

CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM

Applicant Zeus Scientific, Inc.

K-Number K811671

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KPR 1981-09-16

KERMATH L/C ARM

Applicant Kermath Mfg. Corp.

K-Number K812332

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