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TPLC
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Device
nebulizer (direct patient interface)
Regulation Description
Nebulizer.
Product Code
CAF
Regulation Number
868.5630
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADHERIUM (NZ) LTD
SUBSTANTIALLY EQUIVALENT
4
AEROGEN LTD.
SUBSTANTIALLY EQUIVALENT
1
AIREHEALTH INC.
SUBSTANTIALLY EQUIVALENT
1
BREATHESUITE INC
SUBSTANTIALLY EQUIVALENT
1
DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO.LTD.
SUBSTANTIALLY EQUIVALENT
1
ENCHANT TEK CO. LTD.
SUBSTANTIALLY EQUIVALENT
1
EXCELLENTCARE MEDICAL (HUIZHOU) LTD.
SUBSTANTIALLY EQUIVALENT
1
FEELLIFE HEALTH INC.
SUBSTANTIALLY EQUIVALENT
1
FISHER & PAYKEL HEALTHCARE LIMITED
SUBSTANTIALLY EQUIVALENT
1
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
HCMED INNOVATIONS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MANKIND PHARMA LIMITED
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTIRES, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES LP
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, LP
SUBSTANTIALLY EQUIVALENT
1
MONAGHAN MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
OCHSNER CLINIC FOUNDATION
SUBSTANTIALLY EQUIVALENT
1
PARI RESPIRATORY EQUIPMENT, INC.
SUBSTANTIALLY EQUIVALENT
2
RECIPROCAL LABS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN HOMED MEDICAL DEVICE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN IVANKACA TECHNOLOGY CO., LTD
SUBSTANTIALLY EQUIVALENT
1
THAYER MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
THE RITEDOSE CORPORATION
SUBSTANTIALLY EQUIVALENT
1
TRUDELL MEDICAL INTERNATIONAL
SUBSTANTIALLY EQUIVALENT
2
VAPOTHERM INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
117
117
2021
161
161
2022
55
55
2023
107
107
2024
102
103
2025
78
78
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Deliver
110
110
Break
33
33
Connection Problem
30
30
Use of Device Problem
24
24
Mechanical Problem
22
22
Defective Device
20
20
Adverse Event Without Identified Device or Use Problem
18
18
Leak/Splash
18
18
Disconnection
17
17
Insufficient Information
16
16
Melted
15
15
Failure to Infuse
14
14
Improper Flow or Infusion
13
13
Output Problem
12
12
Fire
12
12
Therapeutic or Diagnostic Output Failure
12
12
Infusion or Flow Problem
11
11
Patient Device Interaction Problem
11
11
Fluid/Blood Leak
10
10
Smoking
10
10
Failure to Power Up
8
8
Insufficient Flow or Under Infusion
8
9
Appropriate Term/Code Not Available
8
8
Detachment of Device or Device Component
8
8
Overheating of Device
6
6
Component Missing
6
6
Electrical /Electronic Property Problem
6
6
Defective Component
6
6
Loose or Intermittent Connection
6
6
Gas/Air Leak
6
6
Unexpected Shutdown
6
6
Incorrect, Inadequate or Imprecise Result or Readings
5
5
Material Integrity Problem
5
5
No Flow
5
5
Degraded
5
5
Contamination
5
5
Thermal Decomposition of Device
5
5
Material Too Soft/Flexible
4
4
Temperature Problem
4
4
Sparking
4
4
Unexpected Therapeutic Results
4
4
Restricted Flow rate
4
4
Failure to Charge
4
4
Partial Blockage
4
4
Product Quality Problem
4
4
Material Rupture
3
3
Device Displays Incorrect Message
3
3
Pressure Problem
3
3
Device Emits Odor
3
3
Inaccurate Delivery
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
338
339
Insufficient Information
86
86
No Consequences Or Impact To Patient
52
52
No Known Impact Or Consequence To Patient
23
23
Low Oxygen Saturation
15
15
Dyspnea
15
15
No Patient Involvement
14
14
Unspecified Respiratory Problem
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Swelling/ Edema
6
6
Unintended Extubation
5
5
Aspiration/Inhalation
5
5
Chronic Obstructive Pulmonary Disease (COPD)
4
4
Respiratory Insufficiency
4
4
Dizziness
4
4
No Information
3
3
Headache
3
3
Cyanosis
3
3
Bacterial Infection
3
3
Asthma
3
3
Arrhythmia
3
3
Itching Sensation
3
3
Increased Respiratory Rate
3
3
Pneumonia
2
2
Pneumothorax
2
2
Rash
2
2
Pulmonary Hypertension
2
2
Cough
2
2
Airway Obstruction
2
2
Apnea
2
2
Muscle Weakness
2
2
Urinary Frequency
2
2
Fibrosis
2
2
Burn(s)
2
2
Chest Pain
2
2
Sore Throat
2
2
Bronchospasm
2
2
Hypersensitivity/Allergic reaction
2
2
Hypoxia
2
2
Unspecified Infection
2
2
High Pulmonary Arterial Wedge Pressure
2
2
Viral Infection
1
1
Wheezing
1
1
Ulcer
1
1
Respiratory Arrest
1
1
Heart Failure/Congestive Heart Failure
1
1
Partial thickness (Second Degree) Burn
1
1
Malaise
1
1
Missed Dose
1
1
Fungal Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
MEDLINE INDUSTRIES, LP - Northfield
I
Sep-14-2023
2
Smiths Medical ASD Inc.
II
Apr-29-2021
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