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

HHD 1982-06-25

REGULAR MAXITHINS PADS & SUPER MAXITHINS

Applicant Tampax, Inc.

K-Number K821800

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ESD 1982-06-25

SERIES M PUSH-PULL INPUT COMPRESSION

Applicant Maico Hearing Instruments, Inc.

K-Number K821760

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EKX 1982-06-25

J. MORITA FLEX M-3 TORX HARDPIECE

Applicant Pacific Dental Corp.

K-Number K821739

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N/A 1982-06-25

ADVANCE C-REACTIVE PROTEIN (CRP) ASSAY

Applicant Syva Co.

K-Number K821815

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JPC 1982-06-25

QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL

Applicant Isolab, Inc.

K-Number K820630

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FJI 1982-06-25

ERIKA HPF 50 DIALYZER

Applicant Erika, Inc.

K-Number K821587

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CFR 1982-06-25

ULTRACHEM E-GLU #64976&65040

Applicant Emd Chemicals, Inc.

K-Number K821475

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CDX 1982-06-25

ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT

Applicant Amf Biological and Diagnostics Co.

K-Number K821554

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KLQ 1982-06-25

MACRO-VUE CARD TEST, AMIKACIN

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K821771

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DSH 1982-06-25

MEDILAC #SR4 & SR 40

Applicant Spelna, Inc.

K-Number K820256

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GAA 1982-06-25

INJECTION ASPIRATING NEEDLES

Applicant American Endoscopy, Inc.

K-Number K821697

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DRT 1982-06-25

PHYSIOLOGICAL DISPLAY SYSTEM, MODEL 1000

Applicant Novametrix Medical Systems, Inc.

K-Number K821720

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