Nonin Medical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Nonin Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Nonin OTC Pulse Oximeter Model 3250, H500 Multi-Sensing Oximetry System, Pulse Oximeter
50
Total
50
Cleared
0
Denied
Nonin Medical, Inc. has 50 FDA 510(k) cleared anesthesiology devices. Based in White Bear Lake, US.
Latest FDA clearance: Nov 2024. Active since 1986.
Browse the complete list of FDA 510(k) cleared anesthesiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Covance by Labcorp as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Nonin Medical, Inc.
50 devices
Cleared
Nov 13, 2024
Nonin OTC Pulse Oximeter Model 3250
Anesthesiology
1279d
Cleared
Jun 29, 2020
H500 Multi-Sensing Oximetry System
Anesthesiology
258d
Cleared
Dec 20, 2019
Pulse Oximeter
Anesthesiology
210d
Cleared
May 02, 2019
SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model...
General & Plastic Surgery
58d
Cleared
CT
May 11, 2018
Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor
Anesthesiology
252d
Cleared
Dec 23, 2016
Model X-100C CO-Met™ Oximetry System
Anesthesiology
326d
Cleared
Aug 05, 2016
Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors...
Anesthesiology
128d
Cleared
Aug 27, 2015
SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg,...
Cardiovascular
101d
Cleared
Jul 07, 2014
PULSE OXIMETER
Anesthesiology
98d
Cleared
Feb 21, 2014
SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM
Anesthesiology
204d
Cleared
Sep 11, 2013
PULSE OXIMETER
Anesthesiology
152d
Cleared
May 14, 2012
MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
Cardiovascular
195d
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