Medical Device Manufacturer · US , Rockland , MA

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

52 submissions · 52 cleared · Since 2004

Recent clearances: Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe, Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula, Hypodermic Needle-Pro EDGE Safety Device

View 52 510(k) Devices ↓

52

Total

52

Cleared

0

Denied

FDA 510(k) Regulatory Record - Smiths Medical Asd, Inc. Cardiovascular ✕

6 devices

1-6 of 6

Cleared Jul 26, 2018

Level 1 Convective Warmer

Cardiovascular · 29d

Cleared Nov 09, 2017

HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit,...

Cardiovascular · 87d

Cleared May 24, 2017

HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit,...

Cardiovascular · 191d

Cleared Jun 03, 2009

LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL...

Cardiovascular · 203d

Cleared Aug 01, 2006

LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET

Cardiovascular · 61d

Cleared Apr 27, 2004

SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000

Cardiovascular · 48d