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 1979-05-01

BEHIND-THE-EAR, MODEL H37D

Applicant Marcon Hearing Instruments, Inc.

K-Number K790727

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ESD 1979-05-01

MODEL H58-BEHIND-THE-EAR HEARING INSTR.

Applicant Marcon Hearing Instruments, Inc.

K-Number K790697

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ESD 1979-05-01

BEHIND-THE-EAR HEARING INSTRUMENT, H54

Applicant Marcon Hearing Instruments, Inc.

K-Number K790726

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GTZ 1979-05-01

SERO-STAT STREPTOCOCCUS TEST

Applicant Scott Laboratories, Inc.

K-Number K790492

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JSC 1979-05-01

PEPTONE-YEAST EXTRACT BROTH

Applicant Anaerobe Systems

K-Number K790625

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JHS 1979-05-01

DATA-ZYME CK CALORIMETRIC/UV PROCEDURE

Applicant Data Medical Associates, Inc.

K-Number K790343

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CIJ 1979-05-01

SZAMYL 6.5

Applicant Worthington Diagnostic Systems

K-Number K790474

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EJS 1979-05-01

GDC-685

Applicant Deringer-Ney, Inc.

K-Number K790641

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FPA 1979-04-30

EPIC D215

Applicant National Patent Development Corp.

K-Number K790574

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KLE 1979-04-30

VISIO-BOND

Applicant Espe GmbH (Us)

K-Number K790833

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KME 1979-04-30

INFANT SCALE DISPOSABLE LINER

Applicant Hydro-Med Products, Inc.

K-Number K790659

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FPB 1979-04-30

JELCO* DISC FILTER-0.2 MICRON

Applicant Jelco Laboratories

K-Number K790471

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