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Smiths Industries Medical Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
22
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K972385FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFEDJanuary 20, 1998
K965017REGIONAL ANESTHESIA TRAYSMarch 14, 1997
K962175PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBEJanuary 17, 1997
K962931SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KITOctober 21, 1996
K963570SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)October 18, 1996
K960429PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULAMay 2, 1996
K953485SIMS CPAP SYSTEMOctober 26, 1995
K953483SIMS BLUE LINE ENDOBRONCHIAL TUBEOctober 24, 1995
K932947WALLACE Y-CANSeptember 1, 1995
K932946WALLACE IV CANNULASeptember 1, 1995
K952516PRO-VENT, LINE DRAW, PULSATORJuly 14, 1995
K945777PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGESDecember 22, 1994
K935927CONCORD/PORTEX EPIDURAL CATHETERSSeptember 9, 1994
K942937SHARPSAFE CAT NO. 4105, 4115 AND 4120August 25, 1994
K936133PERCUTANEOUS TRACHEOSTOMY KITMarch 23, 1994
K935776SHARPSAFE, CAT. NO. 4126February 28, 1994
K935777SHARPSAFE, CAT. NO. 4125February 28, 1994
K935603EXTRACORPOREAL TEMPERATURE SENSORFebruary 15, 1994
K935628SHARPSAFE CAT. NO. 4127February 4, 1994
K936134BERMAN AIRWAYJanuary 28, 1994