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

CAF 1979-06-13

I.P.P.B. MANIFOLD & NEBULIZER, UNIVERSAL

Applicant Airlife, Inc.

K-Number K791042

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BTR 1979-06-13

ENDOTRACHEAL TUBES, LONG & SHORT TERM

Applicant Extracorporeal Medical Specialities, Inc.

K-Number K791046

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BTO 1979-06-13

TRACHEOSTOMY TUBES, SHORT AND LONG TERM

Applicant Extracorporeal Medical Specialities, Inc.

K-Number K791044

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DWP 1979-06-13

SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO

Applicant Shiley, Inc.

K-Number K790938

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N/A 1979-06-12

ESTERASE-CHLOROESTERASE, STAINING KIT

Applicant Eureka Laboratories, Inc.

K-Number K791092

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DXE 1979-06-11

ARTERIAL EMBOLECTOMY CATHETER (MODIFIED)

Applicant Shiley, Inc.

K-Number K790838

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LDQ 1979-06-11

SANDEE SANDING BLOCK

Applicant Dr. Bertram L. Steel

K-Number K790504

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KWP 1979-06-11

SANTA CASA DISTRACTOR

Applicant Depuy, Inc.

K-Number K791009

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DQX 1979-06-11

LEAD INTRODUCER SET

Applicant Introstat

K-Number K790882

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FMP 1979-06-11

CONTEX

Applicant Foam Tek, Inc.

K-Number K790995

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GBA 1979-06-11

ELECATH MULTI-PURPOSE ARTERIAL SURGER

Applicant Electro-Catheter Corp.

K-Number K790444

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DRX 1979-06-11

SMART BILECTRODES

Applicant Electronics For Medicine, Inc.

K-Number K791006

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