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TPLC
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Device
apparatus, nitric oxide delivery
Regulation Description
Nitric oxide administration apparatus.
Product Code
MRN
Regulation Number
868.5165
Device Class
2
Premarket Reviews
Manufacturer
Decision
AIRGAS THERAPEUTICS
SUBSTANTIALLY EQUIVALENT
1
AIRGAS THERAPEUTICS LLC
SUBSTANTIALLY EQUIVALENT
1
INTERNATIONAL BIOMEDICAL
SUBSTANTIALLY EQUIVALENT
1
LINDE GAS & EQUIPMENT INC.
SUBSTANTIALLY EQUIVALENT
3
MALINCKRODT MANUFACTURING LLC
SUBSTANTIALLY EQUIVALENT
1
MALLINCKRODT MANUFACTURING LLC
SUBSTANTIALLY EQUIVALENT
4
PRAXAIR, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
199
199
2021
221
221
2022
115
115
2023
99
99
2024
138
138
2025
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Readings
203
203
Failure to Recalibrate
200
200
Intermittent Communication Failure
186
186
Inaccurate Delivery
111
111
Failure to Deliver
106
106
Loose or Intermittent Connection
24
24
Calibration Problem
22
22
Therapeutic or Diagnostic Output Failure
18
18
Device Sensing Problem
15
15
Failure to Calibrate
11
11
Defective Device
9
9
Output Problem
9
9
Excess Flow or Over-Infusion
8
8
Device Displays Incorrect Message
8
8
Incorrect, Inadequate or Imprecise Result or Readings
8
8
Medical Gas Supply Problem
7
7
Device Alarm System
7
7
Break
7
7
Unexpected Shutdown
6
6
Communication or Transmission Problem
6
6
Defective Component
5
5
Adverse Event Without Identified Device or Use Problem
4
4
Protective Measures Problem
4
4
Use of Device Problem
4
4
Battery Problem
4
4
Improper Flow or Infusion
4
4
Infusion or Flow Problem
4
4
Display or Visual Feedback Problem
3
3
Inaccurate Flow Rate
3
3
Complete Loss of Power
2
2
Failure to Sense
2
2
No Flow
2
2
Device-Device Incompatibility
2
2
Inappropriate or Unexpected Reset
2
2
Gas/Air Leak
2
2
Failure to Deliver Shock/Stimulation
2
2
Device Emits Odor
2
2
Insufficient Information
2
2
No Display/Image
2
2
Noise, Audible
2
2
Failure to Charge
2
2
False Alarm
1
1
Insufficient Flow or Under Infusion
1
1
Off-Label Use
1
1
Failure to Auto Stop
1
1
Improper or Incorrect Procedure or Method
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Complete Blockage
1
1
Gas Output Problem
1
1
Product Quality Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
622
622
No Known Impact Or Consequence To Patient
87
87
Low Oxygen Saturation
28
28
Insufficient Information
20
20
No Consequences Or Impact To Patient
13
13
Bradycardia
6
6
Low Blood Pressure/ Hypotension
5
5
Hypoxia
4
4
Tachycardia
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
High Pulmonary Arterial Wedge Pressure
2
2
Irritation
2
2
Cardiac Arrest
2
2
Dyspnea
2
2
Headache
2
2
Nausea
1
1
Underdose
1
1
Malaise
1
1
No Patient Involvement
1
1
Arrhythmia
1
1
Unspecified Respiratory Problem
1
1
Collapse
1
1
Diminished Pulse Pressure
1
1
Loss of consciousness
1
1
Pulmonary Dysfunction
1
1
Death
1
1
Overdose
1
1
Chemical Exposure
1
1
Pulmonary Hypertension
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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