Medical Device Manufacturer · US , Plymouth , MN

Sterilmed, Inc. - FDA 510(k) Cleared Devices

64 submissions · 64 cleared · Since 2001

Recent clearances: Reprocessed DECANAV™ Electrophysiology Catheter, Reprocessed ViewFlex™ Xtra ICE Catheter, Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology

64

Total

64

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sterilmed, Inc. Anesthesiology ✕

4 devices

1-4 of 4

Cleared Feb 18, 2011

REPROCESSED PULSE OXIMETER SENSORS

Anesthesiology · 164d

Cleared Nov 03, 2009

REPROCESSED PULSE OXIMETER SENSORS

Anesthesiology · 90d

Cleared Sep 23, 2004

MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS

Anesthesiology · 146d

Cleared Mar 28, 2003

REPROCESSED PULSE OXIMETER SENSORS

Anesthesiology · 591d