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. Orthopedic ✕

5 devices

1-5 of 5

Cleared Jun 25, 2010

REPROCESSED PINS

Orthopedic · 105d

Cleared Mar 02, 2009

REPROCESSED EXTERNAL FIXATION DEVICE

Orthopedic · 83d

Cleared Aug 18, 2008

REPROCESSED EXTERNAL FIXATION DEVICE

Orthopedic · 74d

Cleared Aug 13, 2008

REPROCESSED EXTERNAL FIXATION ACCESSORIES

Orthopedic · 92d

Cleared Nov 02, 2001

REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES

Orthopedic · 87d