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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
instrument, surgical, non-powered
Product Code
HAO
Regulation Number
882.4535
Device Class
1
Premarket Reviews
Manufacturer
Decision
SHENZHEN SHINEYARD MEDICAL DEVICE CO. LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
19
19
2020
7
7
2021
10
10
2022
10
10
2023
12
12
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
25
25
Material Integrity Problem
5
5
Detachment of Device or Device Component
5
5
Material Puncture/Hole
4
4
Material Fragmentation
4
4
Unsealed Device Packaging
3
3
Fracture
3
3
No Apparent Adverse Event
2
2
Material Split, Cut or Torn
1
1
Mechanical Problem
1
1
Incomplete or Missing Packaging
1
1
Physical Resistance/Sticking
1
1
Separation Failure
1
1
Unintended Movement
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Use of Device Problem
1
1
Material Twisted/Bent
1
1
Material Perforation
1
1
Device Damaged by Another Device
1
1
Packaging Problem
1
1
Explosion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
23
23
No Consequences Or Impact To Patient
18
18
Foreign Body In Patient
7
7
No Known Impact Or Consequence To Patient
5
5
Insufficient Information
5
5
Device Embedded In Tissue or Plaque
3
3
Hydrocephalus
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Patient Problem/Medical Problem
1
1
Injury
1
1
No Patient Involvement
1
1
-
-