Medical Device Manufacturer · US , Keene , NH

Smiths Industries Medical Systems, Inc. - FDA 510(k) Cleared Devices

22 submissions · 19 cleared · Since 1993

Recent clearances: FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED, REGIONAL ANESTHESIA TRAYS, PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE

22

Total

19

Cleared

0

Denied

FDA 510(k) Regulatory Record - Smiths Industries Medical Systems, Inc. General Hospital ✕

8 devices

1-8 of 8

Cleared Oct 18, 1996

SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)

General Hospital · 43d

Cleared Sep 01, 1995

WALLACE IV CANNULA

General Hospital · 806d

Cleared Sep 01, 1995

General Hospital · 806d

Cleared Aug 25, 1994

SHARPSAFE CAT NO. 4105, 4115 AND 4120

General Hospital · 64d

Cleared Feb 28, 1994

SHARPSAFE, CAT. NO. 4126

General Hospital · 87d

Cleared Feb 28, 1994

SHARPSAFE, CAT. NO. 4125

General Hospital · 87d

Cleared Feb 15, 1994

EXTRACORPOREAL TEMPERATURE SENSOR

General Hospital · 89d

Cleared Feb 04, 1994

SHARPSAFE CAT. NO. 4127

General Hospital · 73d