Bio Protech, Inc. is one of 12913 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bio Protech, Inc. - FDA 510(k) Cleared Devices
Recent clearances: EvaQMax Smoke Evacuation System, Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes, Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
17
Total
17
Cleared
0
Denied
Bio Protech, Inc. has 17 FDA 510(k) cleared medical devices. Based in Sparks, US.
Historical record: 17 cleared submissions from 2002 to 2019. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Bio Protech, Inc. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Bio Protech USA, Inc., Underwriters Laboratories, Inc. and Entela, Inc..
FDA 510(k) Regulatory Record - Bio Protech, Inc.
17 devices
Cleared
Aug 29, 2019
EvaQMax Smoke Evacuation System
General Hospital
30d
Cleared
Jun 03, 2016
Disposable Concentric Needle electrodes, Disposable Monopolar Needle...
Neurology
238d
Cleared
Mar 21, 2016
Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
Neurology
158d
Cleared
Jul 16, 2015
PROPENCIL Smoke Pencil
General & Plastic Surgery
260d
Cleared
Nov 17, 2014
CUTANEOUS ELECTRODES
Neurology
108d
Cleared
Sep 13, 2011
REUSABLE STIMULATING ELECTRODES
Neurology
133d
Cleared
Nov 24, 2010
MAX-IF1000
Neurology
301d
Cleared
Nov 30, 2009
MAXEMS, MODELS 1000 AND 2000
Physical Medicine
216d
Cleared
Nov 25, 2009
PROPENCIL ESU PENCIL
General & Plastic Surgery
82d
Cleared
Nov 24, 2009
PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C
General & Plastic Surgery
76d
Cleared
Nov 07, 2008
TELECTRODE WET GEL ECG ELECTRODE
Cardiovascular
14d
Cleared
Feb 07, 2008
PROSTIM 1000/2000
Neurology
62d