Medical Device Manufacturer · US , Plymouth , MN

Sterilmed, Inc.

64 submissions · 64 cleared · Since 2001
64
Total
64
Cleared
0
Denied

Sterilmed, Inc. — FDA 510(k) Submissions

Sterilmed, Inc. has submitted 64 FDA 510(k) premarket notifications since 2001, of which 64 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Recording, Electrode, Reprocessed, Single-use Reprocessed Ultrasonic Surgical Instruments, Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed, Laparoscope, General & Plastic Surgery, Reprocessed, Reprocessed Intravascular Ultrasound Catheter . Use the specialty filter in the sidebar to narrow results.

64 devices
1–25 of 64
Reprocessed DECANAV? Electrophysiology Catheter; Reprocessed WEBSTER? Duo-Decapolar Electrophysiology Catheter
K240826 · NLH Catheter, Recording,... · Cardiovascular
Oct 2024 199d
Reprocessed ViewFlex? Xtra ICE Catheter
K190478 · OWQ Reprocessed Intravascular... · Cardiovascular
Nov 2019 260d
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
K190610 · NLQ Single-use Reprocessed... · General & Plastic Surgery
Aug 2019 157d
Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis
K182272 · NLQ Single-use Reprocessed... · General & Plastic Surgery
Apr 2019 236d
SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
K161700 · OWQ Reprocessed Intravascular... · Cardiovascular
Nov 2016 154d
Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)
K161086 · NUJ Electrosurgical, Cutting... · General & Plastic Surgery
Sep 2016 155d
Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter
K153006 · NLH Catheter, Recording,... · Cardiovascular
Jun 2016 253d
Reprocessed Steerable Introducer
K152090 · PNE Reprocessed Catheter... · Cardiovascular
Mar 2016 240d
Reprocessed Vessel Sealer
K152134 · NUJ Electrosurgical, Cutting... · General & Plastic Surgery
Jan 2016 168d
Reprocessed Electrophysiology Diagnostic Catheters
K150357 · NLH Catheter, Recording,... · Cardiovascular
Aug 2015 196d
Reprocessed Cordless Ultrasonic Dissection Device
K143562 · NLQ Single-use Reprocessed... · General & Plastic Surgery
May 2015 155d
Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider
K143260 · NUJ Electrosurgical, Cutting... · General & Plastic Surgery
Feb 2015 102d
REPROCESSED HARMONIC SHEAR
K132566 · NLQ Single-use Reprocessed... · General & Plastic Surgery
Jun 2014 303d
REPROCESSED CLOSURE SYSTEM
K133414 · NLM Laparoscope, General &... · General & Plastic Surgery
Jan 2014 76d
REPROCESSED VESSEL SEALER
K123096 · NUJ Electrosurgical, Cutting... · General & Plastic Surgery
Jan 2013 115d
REPROCESSED SURGICAL ELECTRIC INSTRUMENT
K120040 · NUJ Electrosurgical, Cutting... · General & Plastic Surgery
Oct 2012 274d
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K121158 · NLH Catheter, Recording,... · Cardiovascular
Aug 2012 112d
REPROCESSED ENDOSCOPIC TROCARS
K121240 · NLM Laparoscope, General &... · Gastroenterology & Urology
Jun 2012 48d
REPROCESSED FEMORAL COMPRESSION DEVICE
K120204 · NMF Clamp, Vascular, Reprocessed · Cardiovascular
Apr 2012 71d
REPROCESSED HARMONIC SCALPEL
K111794 · NLQ Single-use Reprocessed... · General & Plastic Surgery
Jan 2012 198d
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER
K110076 · OWQ Reprocessed Intravascular... · Cardiovascular
Aug 2011 219d
REPROCESSED ENDOSCOPIC TROCARS
K111002 · NLM Laparoscope, General &... · Gastroenterology & Urology
Jul 2011 98d
REPROCESSED PULSE OXIMETER SENSORS
K102560 · NLF Oximeter, Reprocessed · Anesthesiology
Feb 2011 164d
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K101789 · NLH Catheter, Recording,... · Cardiovascular
Aug 2010 52d
REPROCESSED PINS
K100707 · NDM Pin, Fixation, Threaded,... · Orthopedic
Jun 2010 105d
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