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TPLC
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2024
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Device
apparatus, nitric oxide delivery
Product Code
MRN
Regulation Number
868.5165
Device Class
2
Premarket Reviews
Manufacturer
Decision
AIRGAS THERAPEUTICS
SUBSTANTIALLY EQUIVALENT
1
INTERNATIONAL BIOMEDICAL
SUBSTANTIALLY EQUIVALENT
1
LINDE GAS & EQUIPMENT INC.
SUBSTANTIALLY EQUIVALENT
2
MALLINCKRODT MANUFACTURING LLC
SUBSTANTIALLY EQUIVALENT
3
PRAXAIR, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
144
144
2020
199
199
2021
221
221
2022
115
115
2023
99
99
2024
15
15
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Readings
162
162
Failure to Recalibrate
159
159
Intermittent Communication Failure
156
156
Inaccurate Delivery
133
133
Failure to Deliver
109
109
Calibration Problem
34
34
Therapeutic or Diagnostic Output Failure
32
32
Device Alarm System
28
28
Failure to Calibrate
27
27
Device Displays Incorrect Message
23
23
Excess Flow or Over-Infusion
21
21
Loose or Intermittent Connection
20
20
Device Sensing Problem
15
15
Protective Measures Problem
14
14
Defective Device
14
14
Break
12
12
Incorrect, Inadequate or Imprecise Result or Readings
11
11
Output Problem
10
10
Medical Gas Supply Problem
7
7
Defective Component
7
7
Display or Visual Feedback Problem
7
7
Inaccurate Flow Rate
6
6
No Flow
6
6
Communication or Transmission Problem
6
6
Unexpected Shutdown
5
5
Appropriate Term/Code Not Available
5
5
Infusion or Flow Problem
5
5
Battery Problem
5
5
Improper Flow or Infusion
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Use of Device Problem
4
4
Failure to Sense
3
3
Failure to Deliver Shock/Stimulation
3
3
Device Emits Odor
2
2
Loss of Power
2
2
Insufficient Flow or Under Infusion
2
2
High Test Results
2
2
Power Problem
2
2
Charging Problem
2
2
Noise, Audible
2
2
Complete Loss of Power
1
1
Insufficient Information
1
1
Inadequate Instructions for Non-Healthcare Professional
1
1
Failure to Auto Stop
1
1
Gas/Air Leak
1
1
Pressure Problem
1
1
Temperature Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Application Program Problem
1
1
Precipitate in Device or Device Ingredient
1
1
Off-Label Use
1
1
Product Quality Problem
1
1
Unable to Obtain Readings
1
1
Improper or Incorrect Procedure or Method
1
1
Output above Specifications
1
1
Fluid/Blood Leak
1
1
Gas Output Problem
1
1
Electrical /Electronic Property Problem
1
1
No Display/Image
1
1
Circuit Failure
1
1
Complete Blockage
1
1
False Alarm
1
1
Low Audible Alarm
1
1
No Audible Alarm
1
1
Signal Artifact/Noise
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
497
497
No Known Impact Or Consequence To Patient
182
182
No Consequences Or Impact To Patient
37
37
No Patient Involvement
24
24
Low Oxygen Saturation
22
22
Insufficient Information
19
19
Bradycardia
6
6
Hypoxia
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Low Blood Pressure/ Hypotension
3
3
Tachycardia
2
2
No Information
2
2
Irritation
2
2
Dyspnea
2
2
Headache
2
2
Cardiac Arrest
1
1
Death
1
1
Nausea
1
1
Overdose
1
1
Pulmonary Dysfunction
1
1
High Pulmonary Arterial Wedge Pressure
1
1
Underdose
1
1
Chemical Exposure
1
1
Diminished Pulse Pressure
1
1
Malaise
1
1
Collapse
1
1
Loss of consciousness
1
1
Pulmonary Hypertension
1
1
Unspecified Respiratory Problem
1
1
Arrhythmia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Mallinckrodt, LLC.
II
Sep-13-2022
2
NOXBOX LTD
I
Jun-09-2023
3
Vero Biotech, LLC
II
Dec-15-2023
4
Vero Biotech, LLC
I
Sep-30-2021
5
Vero Biotech, LLC
I
Jun-23-2021
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