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TPLC
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Device
transmitters and receivers, physiological signal, radiofrequency
Product Code
DRG
Regulation Number
870.2910
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOINTELLISENSE INC.
SUBSTANTIALLY EQUIVALENT
1
BIOLNTELLISENSE INC.
SUBSTANTIALLY EQUIVALENT
1
BRAVEHEART WIRELESS, INC.
SUBSTANTIALLY EQUIVALENT
1
CARETAKER MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
COMARCH HEALTHCARE SA
SUBSTANTIALLY EQUIVALENT
1
ELASTIC CARE INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
ERGOLINE GMBH
SUBSTANTIALLY EQUIVALENT
1
GRAFTWORX, INC. DBA ALIO
SUBSTANTIALLY EQUIVALENT
1
HMICRO, INC.
SUBSTANTIALLY EQUIVALENT
1
ISANSYS LIFECARE LTD
SUBSTANTIALLY EQUIVALENT
1
LIFESIGNALS, INC.
SUBSTANTIALLY EQUIVALENT
2
MC10 INC.
SUBSTANTIALLY EQUIVALENT
1
MORTARA INSTRUMENT INC
SUBSTANTIALLY EQUIVALENT
1
PHILIPS MEDICAL SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
SIBEL INC.
SUBSTANTIALLY EQUIVALENT
2
SIGKNOW BIOMEDICAL CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
SYNERGEN TECHNOLOGY LABS LLC
SUBSTANTIALLY EQUIVALENT
1
VITALCONNECT, INC.
SUBSTANTIALLY EQUIVALENT
4
VITLS INC.
SUBSTANTIALLY EQUIVALENT
1
VIVALNK, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
166
166
2019
70
70
2020
82
82
2021
107
107
2022
44
44
Device Problems
MDRs with this Device Problem
Events in those MDRs
Communication or Transmission Problem
214
214
Thermal Decomposition of Device
76
76
Failure to Power Up
47
47
Output Problem
29
29
Adverse Event Without Identified Device or Use Problem
24
24
Intermittent Communication Failure
17
17
Loss of Power
16
16
Computer Software Problem
14
14
Signal Artifact/Noise
11
11
Application Program Problem
10
10
Power Problem
7
7
Incorrect, Inadequate or Imprecise Result or Readings
7
7
Smoking
7
7
Overheating of Device
6
6
Appropriate Term/Code Not Available
6
6
Device Issue
6
6
Sparking
5
5
Protective Measures Problem
5
5
Incomplete or Inadequate Connection
5
5
Device Operational Issue
4
4
Break
4
4
Device Alarm System
4
4
Charred
3
3
No Display/Image
3
3
Temperature Problem
3
3
Device Emits Odor
3
3
Radio Signal Problem
3
3
Unintended Application Program Shut Down
3
3
Radiofrequency Interference (RFI)
2
2
Wireless Communication Problem
2
2
Unintended Electrical Shock
2
2
Incorrect Interpretation of Signal
2
2
Operating System Becomes Nonfunctional
2
2
Display or Visual Feedback Problem
2
2
Melted
2
2
Connection Problem
2
2
Device Difficult to Maintain
1
1
Complete Loss of Power
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Electrical /Electronic Property Problem
1
1
Moisture Damage
1
1
Material Rupture
1
1
High Readings
1
1
Device Displays Incorrect Message
1
1
Biocompatibility
1
1
No Audible Alarm
1
1
Filtration Problem
1
1
Incorrect Measurement
1
1
Patient Data Problem
1
1
Application Program Version or Upgrade Problem
1
1
Application Security Problem
1
1
Device Operates Differently Than Expected
1
1
Material Separation
1
1
Telemetry Discrepancy
1
1
Image Display Error/Artifact
1
1
Application Program Problem: Parameter Calculation Error
1
1
Power Conditioning Problem
1
1
Device Inoperable
1
1
Improper or Incorrect Procedure or Method
1
1
Defective Component
1
1
Device Sensing Problem
1
1
Improper Alarm
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
208
208
No Known Impact Or Consequence To Patient
183
183
No Consequences Or Impact To Patient
68
68
No Information
27
27
Death
4
4
No Patient Involvement
4
4
Insufficient Information
3
3
Partial thickness (Second Degree) Burn
2
2
Contact Dermatitis
2
2
Electric Shock
2
2
Unspecified Tissue Injury
1
1
Hypoxia
1
1
Shock
1
1
Tissue Damage
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Nihon Kohden America Inc
II
Mar-02-2021
2
Vitalconnect Inc.
II
Jul-10-2020
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