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TPLC
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Device
scaler, ultrasonic
Product Code
ELC
Regulation Number
872.4850
Device Class
2
Premarket Reviews
Manufacturer
Decision
CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO.,LTD
SUBSTANTIALLY EQUIVALENT
1
E.M.S ELECTRO MEDICAL SYSTEMS S.A
SUBSTANTIALLY EQUIVALENT
1
E.M.S ELECTRO MEDICAL SYSTEMS S.A.
SUBSTANTIALLY EQUIVALENT
1
ENGINEERED ENDODONTICS
SUBSTANTIALLY EQUIVALENT
1
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MICRON CORPORATION
SUBSTANTIALLY EQUIVALENT
1
SCHLUMBOHM GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
SONENDO, INC
SUBSTANTIALLY EQUIVALENT
1
SONENDO, INC.
SUBSTANTIALLY EQUIVALENT
1
TTBIO CORP.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2018
289
289
2019
302
302
2020
164
164
2021
166
166
2022
165
165
2023
37
37
Device Problems
MDRs with this Device Problem
Events in those MDRs
Overheating of Device
501
501
Break
413
413
Restricted Flow rate
275
275
Temperature Problem
69
69
No Flow
30
30
Infusion or Flow Problem
19
19
Improper Flow or Infusion
11
11
Material Fragmentation
10
10
Device Operates Differently Than Expected
8
8
Device Emits Odor
7
7
Insufficient Information
7
7
Fluid/Blood Leak
7
7
Insufficient Flow or Under Infusion
7
7
Unintended Electrical Shock
6
6
Component Missing
5
5
Excessive Heating
4
4
Noise, Audible
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Power Problem
3
3
Detachment of Device or Device Component
3
3
Patient-Device Incompatibility
3
3
Therapeutic or Diagnostic Output Failure
3
3
Defective Device
3
3
Mechanical Problem
3
3
Fracture
3
3
Detachment Of Device Component
3
3
Inaccurate Flow Rate
2
2
Leak/Splash
2
2
Loose or Intermittent Connection
2
2
Melted
2
2
Decrease in Pressure
2
2
Difficult to Remove
2
2
Sparking
2
2
Defective Component
2
2
Smoking
2
2
Appropriate Term/Code Not Available
2
2
Ejection Problem
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Material Integrity Problem
2
2
Moisture or Humidity Problem
2
2
Naturally Worn
1
1
Device Dislodged or Dislocated
1
1
Free or Unrestricted Flow
1
1
Output Problem
1
1
Material Twisted/Bent
1
1
Blocked Connection
1
1
Device Handling Problem
1
1
Activation Problem
1
1
Separation Problem
1
1
Device Stops Intermittently
1
1
Vibration
1
1
Obstruction of Flow
1
1
Material Separation
1
1
Product Quality Problem
1
1
Failure to Power Up
1
1
Device Maintenance Issue
1
1
Difficult to Insert
1
1
Intermittent Continuity
1
1
Corroded
1
1
Electrical /Electronic Property Problem
1
1
Thermal Decomposition of Device
1
1
Complete Blockage
1
1
Alarm Not Visible
1
1
Bent
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
615
615
No Clinical Signs, Symptoms or Conditions
390
390
No Known Impact Or Consequence To Patient
128
128
Insufficient Information
62
62
No Information
48
48
Foreign Body In Patient
16
16
Device Embedded In Tissue or Plaque
13
13
Burn(s)
8
8
Pain
6
6
Injury
4
4
Swelling
4
4
Burn, Thermal
4
4
Needle Stick/Puncture
3
3
Numbness
3
3
Tinnitus
2
2
Hemorrhage/Bleeding
2
2
No Code Available
2
2
No Patient Involvement
2
2
Patient Problem/Medical Problem
2
2
Bowel Perforation
1
1
Fluid Discharge
1
1
Electric Shock
1
1
Skin Burning Sensation
1
1
Unspecified Tissue Injury
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Laceration(s)
1
1
Undesired Nerve Stimulation
1
1
Skin Discoloration
1
1
Dyspnea
1
1
Airway Obstruction
1
1
Exposure to Body Fluids
1
1
Tissue Damage
1
1
Dysphasia
1
1
Sensitivity of Teeth
1
1
Sinus Perforation
1
1
Discomfort
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Sonendo Inc
II
Nov-14-2022
2
Sonendo Inc
II
May-28-2020
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