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 1981-06-26

RIONET HEARING AID HB-69S

Applicant Rion Acoustic Instruments, Inc.

K-Number K811529

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EJH 1981-06-26

SUMMAR NON-PRECIOUS, CERAMIC ALLOY

Applicant Shofu Dental Corp.

K-Number K811013

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KQT 1981-06-26

SUCTION WOUND DRAINAGE DEVICE

Applicant The Urology Group

K-Number K810739

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EBC 1981-06-26

VISIO-SEAL

Applicant Espe-Premier Sales Co.

K-Number K811624

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EMA 1981-06-26

FUJI IONOMER TYPE I & II

Applicant G-C Intl. Corp.

K-Number K811521

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N/A 1981-06-26

K-FLEX

Applicant Sybron Corp.

K-Number K811519

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JSS 1981-06-26

SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K811434

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BTO 1981-06-26

SHILEY DISPOSABLE CANNULA TRACH. TUBE

Applicant Shiley, Inc.

K-Number K811447

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FPA 1981-06-26

LO-VOL I.V. SETS

Applicant Sea Medical Products, Inc.

K-Number K811561

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KNT 1981-06-26

ETHIX FEEDING TUBES POLYURETHANE/RADIOP.

Applicant Ethox Corp.

K-Number K811639

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CKG 1981-06-25

ACTH RADIOIMMUNOASSAY KIT

Applicant Immuno Nuclear Corp.

K-Number K811565

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JSJ 1981-06-25

PHENYETHYL ALCOHOL AGAR

Applicant Micro Media Laboratories

K-Number K811601

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