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TPLC
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Device
nebulizer (direct patient interface)
Product Code
CAF
Regulation Number
868.5630
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADHERIUM (NZ) LTD
SUBSTANTIALLY EQUIVALENT
9
AEROGEN LTD.
SUBSTANTIALLY EQUIVALENT
1
AIREHEALTH INC.
SUBSTANTIALLY EQUIVALENT
1
BREATHESUITE INC
SUBSTANTIALLY EQUIVALENT
1
COGNITA LABS, LLC
SUBSTANTIALLY EQUIVALENT
1
DONGGUAN SIMZO ELECTRONIC TECHNOLOGY 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
1. K230602
Hudson RCI® TurboMist™ Nebulizer System
MEDLINE INDUSTRIES, INC
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, LP
SUBSTANTIALLY EQUIVALENT
1
MICROBASE TECHNOLOGY CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MONAGHAN MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
OCHSNER CLINIC FOUNDATION
SUBSTANTIALLY EQUIVALENT
1
PARI RESPIRATORY EQUIPMENT, INC.
SUBSTANTIALLY EQUIVALENT
2
QINGDAO FUTURE MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
RECIPROCAL LABS CORPORATION
SUBSTANTIALLY EQUIVALENT
2
SHENZHEN HOMED MEDICAL DEVICE CO,.LTD.
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
4
VAPOTHERM INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
162
162
2019
185
185
2020
117
117
2021
161
161
2022
55
55
2023
104
104
2024
37
37
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Deliver
190
190
Connection Problem
70
70
Leak/Splash
63
63
Disconnection
46
46
Break
40
40
Fluid/Blood Leak
23
23
Fitting Problem
23
23
Mechanical Problem
21
21
Defective Device
19
19
Use of Device Problem
17
17
Electrical /Electronic Property Problem
17
17
Improper Flow or Infusion
17
17
Output Problem
15
15
Infusion or Flow Problem
14
14
Gas/Air Leak
14
14
Material Rupture
14
14
Fire
13
13
No Flow
13
13
Therapeutic or Diagnostic Output Failure
13
13
Insufficient Information
13
13
Patient Device Interaction Problem
12
12
Detachment of Device or Device Component
11
11
Defective Component
11
11
Adverse Event Without Identified Device or Use Problem
9
9
Appropriate Term/Code Not Available
7
7
Smoking
7
7
Degraded
7
7
Loose or Intermittent Connection
6
6
Overheating of Device
6
6
Failure to Power Up
6
6
Inaccurate Delivery
6
6
Obstruction of Flow
6
6
Unexpected Shutdown
6
6
Material Integrity Problem
5
5
Sparking
5
5
Improper or Incorrect Procedure or Method
5
5
Component Missing
5
5
Incorrect, Inadequate or Imprecise Result or Readings
5
5
Melted
5
5
Contamination
5
5
Product Quality Problem
4
4
Insufficient Flow or Under Infusion
4
4
Device Operates Differently Than Expected
4
4
Manufacturing, Packaging or Shipping Problem
3
3
Noise, Audible
3
3
Off-Label Use
3
3
Device Displays Incorrect Message
3
3
Charging Problem
3
3
Corroded
3
3
Display or Visual Feedback Problem
3
3
Thermal Decomposition of Device
3
3
Device Emits Odor
3
3
Burst Container or Vessel
2
2
Detachment Of Device Component
2
2
Malposition of Device
2
2
Incomplete or Missing Packaging
2
2
Decrease in Pressure
2
2
Material Split, Cut or Torn
2
2
Packaging Problem
2
2
Pressure Problem
2
2
Protective Measures Problem
2
2
Temperature Problem
2
2
No Pressure
2
2
Electrical Shorting
2
2
Failure to Shut Off
2
2
Device Contamination with Chemical or Other Material
2
2
Complete Loss of Power
2
2
Separation Problem
2
2
Excessive Heating
1
1
Incomplete or Inadequate Connection
1
1
Human-Device Interface Problem
1
1
Device-Device Incompatibility
1
1
Difficult to Open or Close
1
1
Device Ingredient or Reagent Problem
1
1
Device Markings/Labelling Problem
1
1
Material Twisted/Bent
1
1
Mechanics Altered
1
1
Moisture or Humidity Problem
1
1
Power Problem
1
1
Device Handling Problem
1
1
Activation Failure
1
1
Failure to Eject
1
1
Physical Resistance/Sticking
1
1
Device Fell
1
1
Explosion
1
1
Inappropriate Audible Prompt/Feedback
1
1
Device Damaged Prior to Use
1
1
Unexpected Therapeutic Results
1
1
Unstable
1
1
Material Puncture/Hole
1
1
Difficult to Remove
1
1
Material Too Rigid or Stiff
1
1
Material Separation
1
1
Patient-Device Incompatibility
1
1
Battery Problem
1
1
Difficult or Delayed Activation
1
1
Chemical Problem
1
1
Contamination /Decontamination Problem
1
1
Communication or Transmission Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
244
244
No Consequences Or Impact To Patient
231
231
No Known Impact Or Consequence To Patient
93
93
No Patient Involvement
80
80
Insufficient Information
61
61
Low Oxygen Saturation
12
12
Dyspnea
11
11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
No Information
8
8
Unspecified Respiratory Problem
7
7
Respiratory Distress
6
6
Aspiration/Inhalation
5
5
Unintended Extubation
5
5
Swelling/ Edema
4
4
Asthma
4
4
Headache
3
3
Apnea
3
3
No Code Available
3
3
Dizziness
3
3
Bronchospasm
3
3
High Pulmonary Arterial Wedge Pressure
2
2
Urinary Frequency
2
2
Sore Throat
2
2
Increased Respiratory Rate
2
2
Fibrosis
2
2
Cough
2
2
Pulmonary Hypertension
2
2
Respiratory Insufficiency
2
2
Arrhythmia
2
2
Airway Obstruction
2
2
Bacterial Infection
2
2
Bradycardia
2
2
Burn(s)
2
2
Cardiopulmonary Arrest
2
2
Chest Pain
2
2
Cyanosis
2
2
Death
2
2
Hypersensitivity/Allergic reaction
2
2
Hypoxia
2
2
Unspecified Infection
2
2
Itching Sensation
2
2
Pneumonia
2
2
Pneumothorax
2
2
Pulmonary Edema
1
1
Rash
1
1
Laceration(s)
1
1
Occlusion
1
1
Peeling
1
1
Low Blood Pressure/ Hypotension
1
1
Ulcer
1
1
Right Ventricular Dysfunction
1
1
Tachycardia
1
1
Burning Sensation
1
1
Hot Flashes/Flushes
1
1
Abrasion
1
1
Hemorrhage/Bleeding
1
1
Fatigue
1
1
Wheezing
1
1
Respiratory Arrest
1
1
Heart Failure/Congestive Heart Failure
1
1
Skin Inflammation/ Irritation
1
1
Sleep Dysfunction
1
1
Eye Burn
1
1
Burn, Thermal
1
1
Underdose
1
1
Electric Shock
1
1
Missed Dose
1
1
Chemical Exposure
1
1
Decreased Respiratory Rate
1
1
Superficial (First Degree) Burn
1
1
Patient Problem/Medical Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
MEDLINE INDUSTRIES, LP - Northfield
I
Sep-14-2023
2
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
I
Feb-04-2019
3
SANRAI INTERNATIONAL LLC
II
Mar-26-2019
4
Smiths Medical ASD Inc.
II
Apr-29-2021
5
Valeant Pharmacueticals International
II
Jan-17-2018
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