Medical Device Manufacturer · US , Plymouth , MN

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

64 submissions · 64 cleared · Since 2001

64

Total

64

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sterilmed, Inc. General & Plastic Surgery ✕

21 devices

1-12 of 21

Cleared Aug 15, 2019

Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology

General & Plastic Surgery · 157d

Cleared Apr 15, 2019

Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis

General & Plastic Surgery · 236d

Cleared Sep 20, 2016

Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm),...

General & Plastic Surgery · 155d

Cleared Jan 15, 2016

Reprocessed Vessel Sealer

General & Plastic Surgery · 168d

Cleared May 20, 2015

Reprocessed Cordless Ultrasonic Dissection Device

General & Plastic Surgery · 155d

Cleared Feb 23, 2015

Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider

General & Plastic Surgery · 102d

Cleared Jun 14, 2014

REPROCESSED HARMONIC SHEAR

General & Plastic Surgery · 303d

Cleared Jan 22, 2014

REPROCESSED CLOSURE SYSTEM

General & Plastic Surgery · 76d

Cleared Jan 25, 2013

REPROCESSED VESSEL SEALER

General & Plastic Surgery · 115d

Cleared Oct 05, 2012

REPROCESSED SURGICAL ELECTRIC INSTRUMENT

General & Plastic Surgery · 274d

Cleared Jan 11, 2012

REPROCESSED HARMONIC SCALPEL

General & Plastic Surgery · 198d

Cleared Jan 09, 2009

REPROCESSED HARMONIC SCALPEL

General & Plastic Surgery · 87d