Medical Device Manufacturer · US , Plymouth , MN

Smiths Medical Ads, Inc.

2 submissions · 2 cleared · Since 2017

Total

Cleared

Denied

Smiths Medical Ads, Inc. — FDA 510(k) Submissions

Smiths Medical Ads, Inc. has submitted 2 FDA 510(k) premarket notifications since 2017, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Pump, Infusion, Pca, Tube, Tracheostomy (w/wo Connector) . Use the specialty filter in the sidebar to narrow results.

2 devices

1–2 of 2

BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube

K173384 · BTO Tube, Tracheostomy (w/wo... · Anesthesiology

Apr 2018 162d

CADD?- Solis Ambulatory Infusion Pump with Wireless Communication; CADD?-Solis Infusion Pump, Model 2110; PharmGuard? Administrator Medication Safety Software; CADD? Administration Sets; Wireless Communication Module (CM)

K170982 · MEA Pump, Infusion, Pca · General Hospital

Aug 2017 143d

Data Source

FDA 510(k) public files . 174,402 total devices indexed.

Smiths Medical Ads, Inc.

Smiths Medical Ads, Inc. — FDA 510(k) Submissions

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