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

JJX 1981-10-06

C-PEPTIDE CONTROL PACK

Applicant Mallinckrodt Critical Care

K-Number K812690

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DTB 1981-10-06

INTERMEDICS POLY FLEX EPICARDIAL SUTURE

Applicant Intermedics, Inc.

K-Number K812221

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N/A 1981-10-06

MYOCATH CATOLOG NO. MCK-A

Applicant Sorensen Research

K-Number K812052

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CCL 1981-10-06

MONO 2 OXYGEN MONITOR

Applicant Kantron Cardiovascular, Inc.

K-Number K812587

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IQE 1981-10-06

PROSANA BELT

Applicant Bandwagon, Inc.

K-Number K812719

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DTB 1981-10-06

INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL

Applicant Intermedics, Inc.

K-Number K812245

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JKD 1981-10-06

RIA QUANT C-PEPTIDE KIT

Applicant Mallinckrodt Critical Care

K-Number K812689

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JTR 1981-10-06

GC DISK

Applicant Remel Co.

K-Number K812698

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JTN 1981-10-06

MEZLOCILLIN 75 MCG. SENSI-DISC

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K812571

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ELW 1981-10-06

G-C FIT-CHECKER IMPRESSION MATERIAL

Applicant G-C Intl. Corp.

K-Number K812679

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ELW 1981-10-06

EXAFLEX IMPRESSION MATERIAL

Applicant G-C Intl. Corp.

K-Number K812406

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N/A 1981-10-05

KORICLEAN

Applicant Trans World Agency, Inc.

K-Number K812176

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