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

DTB 1978-12-15

LEAD, TIMED PACING, IMPLANTABLE

Applicant Daig Corp.

K-Number K782004

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GBA 1978-12-15

TUBE, LEATHERMAN/IMBRUCE

Applicant National Catheter Co. Div. Mallinckrodt

K-Number K781665

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GYB 1978-12-15

OMNIPREP

Applicant Weaver & Co.

K-Number K781989

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GZJ 1978-12-14

STIMULATOR, MODEL 7727

Applicant Medtronic Vascular

K-Number K782075

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BZG 1978-12-14

AIRFLOMETER

Applicant Glaxo Australia Ply. , Ltd.

K-Number K780894

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DXH 1978-12-13

TRANSMITTER, MODEL 9406 AND 9401

Applicant Medtronic Vascular

K-Number K781986

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BWF 1978-12-13

SPIROCARE 108-B

Applicant Marion Laboratories, Inc.

K-Number K782016

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CBK 1978-12-13

VENTILATOR, MINILUNG

Applicant Thompson Respiration Products, Inc.

K-Number K781160

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IRP 1978-12-12

COMPRESSION DEVICES, LIMB

Applicant Alba-Waldensian, Inc.

K-Number K781964

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EYN 1978-12-12

IRRIGATION TRAY

Applicant Intermed, Inc.

K-Number K781748

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DPS 1978-12-12

MONITOR/MINI SCOPE

Applicant Ipco Corp.

K-Number K781679

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GCY 1978-12-12

FLAT SILICONE DRAIN

Applicant Davol, Inc.

K-Number K782026

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