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

ESD 1982-12-03

HEARING AID #G6H & G6T

Applicant Widex Hearing Aid Co., Inc.

K-Number K823431

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DTB 1982-12-03

PRODUCTS IMPLANTABLE PACING LEAD,TINED

Applicant Oscor, Inc.

K-Number K823446

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JSI 1982-12-03

MYCOTRIUM-GU

Applicant Hana Biologics, Inc.

K-Number K822736

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FQL 1982-12-03

ELASTIC COMPRESSION ANKLET

Applicant Podiatry Products Corp.

K-Number K823350

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LBM 1982-12-03

AUSTIN MODIFIED TOTAL OSSICULAR REPLACE

Applicant Treace Medical, Inc.

K-Number K823441

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JSJ 1982-12-03

MYCAREL AGAR MYCOBROTIC AGAR

Applicant Troy Biologicals, Inc.

K-Number K823308

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JJJ 1982-12-03

CAP-RIA 16

Applicant Capintec, Inc.

K-Number K823240

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LJE 1982-12-03

HEYER-SCHUTE UNIVERSAL URETERAL STENT

Applicant American Hospital Supply Corp.

K-Number K823418

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JSJ 1982-12-03

SCHAEDLER AGARS

Applicant Granite Diagnostics, Inc.

K-Number K823248

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N/A 1982-12-03

FLUSHING SOLUTION

Applicant Nobel Scientific Industries, Inc.

K-Number K823283

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GRA 1982-12-03

ANTIBODY TO MUMPS VIRUS IFA TEST

Applicant Electro-Nucleonics Laboratories, Inc.

K-Number K822826

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HCC 1982-12-03

CALMSET 3 TM

Applicant Thought Technology , Ltd.

K-Number K823146

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