Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
syringe, irrigating (non dental)
Regulation Description
Irrigating syringe.
Product Code
KYZ
Regulation Number
880.6960
Device Class
1
Premarket Reviews
Manufacturer
Decision
SAFKAN, INC.
SUBSTANTIALLY EQUIVALENT
1
1. K201877
OtoSet- Ear Cleaning System
MDR Year
MDR Reports
MDR Events
2020
88
88
2021
41
41
2022
11
11
2023
14
14
2024
106
106
2025
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Contamination with Chemical or Other Material
65
65
Leak/Splash
27
27
Appropriate Term/Code Not Available
20
20
Contamination /Decontamination Problem
20
20
Suction Problem
17
17
Contamination
15
15
Break
13
13
Fluid/Blood Leak
13
13
Mechanical Problem
11
11
Detachment of Device or Device Component
8
8
Device Damaged Prior to Use
7
7
Physical Resistance/Sticking
6
6
Device Markings/Labelling Problem
6
6
Defective Component
4
4
Defective Device
4
4
Suction Failure
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Packaging Problem
4
4
Connection Problem
4
4
Failure to Deliver
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Material Separation
3
3
Output Problem
3
3
Tear, Rip or Hole in Device Packaging
3
3
Decrease in Suction
3
3
Insufficient Information
3
3
Crack
3
3
Infusion or Flow Problem
2
2
Moisture Damage
2
2
Device Contaminated During Manufacture or Shipping
2
2
Use of Device Problem
2
2
Material Integrity Problem
2
2
Material Split, Cut or Torn
2
2
Therapeutic or Diagnostic Output Failure
2
2
Unsealed Device Packaging
1
1
Biocompatibility
1
1
Failure to Clean Adequately
1
1
Ejection Problem
1
1
Patient Device Interaction Problem
1
1
Volume Accuracy Problem
1
1
Partial Blockage
1
1
Filling Problem
1
1
Pressure Problem
1
1
Inability to Irrigate
1
1
Device Contamination with Body Fluid
1
1
Material Too Soft/Flexible
1
1
Display Difficult to Read
1
1
Failure to Seal
1
1
Melted
1
1
Loose or Intermittent Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
150
150
No Known Impact Or Consequence To Patient
59
59
No Patient Involvement
38
38
No Consequences Or Impact To Patient
20
20
Insufficient Information
11
11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Unspecified Infection
3
3
Foreign Body In Patient
3
3
Exposure to Body Fluids
2
2
Fever
2
2
Pain
2
2
Bacterial Infection
1
1
Low Blood Pressure/ Hypotension
1
1
Muscle Weakness
1
1
Pelvic Inflammatory Disease
1
1
Discomfort
1
1
Meningitis
1
1
Fungal Infection
1
1
Thrombosis/Thrombus
1
1
Unspecified Kidney or Urinary Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health 200, LLC
I
Feb-16-2024
2
MEDLINE INDUSTRIES, LP - Northfield
II
Sep-30-2024
3
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-10-2023
-
-