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TPLC
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show TPLC since
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Device
flowmeter, blood, cardiovascular
Product Code
DPW
Regulation Number
870.2100
Device Class
2
Premarket Reviews
Manufacturer
Decision
COOK VASCULAR, INC.
SUBSTANTIALLY EQUIVALENT
1
DELTEX MEDICAL LIMITED
SUBSTANTIALLY EQUIVALENT
4
EM-TEC GMBH
SUBSTANTIALLY EQUIVALENT
1
FLOSONICS MEDICAL
SUBSTANTIALLY EQUIVALENT
2
FLOSONICS MEDICAL (R/A 1929803 ONTARIO CORP.)
SUBSTANTIALLY EQUIVALENT
2
HUNTLEIGH HEALTHCARE LTD
SUBSTANTIALLY EQUIVALENT
1
KOVEN TECHNOLOGY, INC.
SUBSTANTIALLY EQUIVALENT
1
LASER ASSOCIATED SCIENCES, INC.
SUBSTANTIALLY EQUIVALENT
2
MEDI-STIM ASA
SUBSTANTIALLY EQUIVALENT
1
MOOR INSTRUMENTS LTD.
SUBSTANTIALLY EQUIVALENT
1
OR-NIM MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
2
PERIMED AB
SUBSTANTIALLY EQUIVALENT
1
REMINGTON MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
3
RFPI
SUBSTANTIALLY EQUIVALENT
1
SYNOVIS MICRO COMPANIES ALLIANCE, INC.
SUBSTANTIALLY EQUIVALENT
1
TRANSONIC SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
2
VASAMED, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
8
8
2015
12
12
2016
1
1
2017
2
2
2019
3
3
2020
4
4
2021
6
6
2022
1
1
2023
2
2
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Displays Incorrect Message
14
14
Output Problem
5
5
Break
4
4
Pumping Stopped
3
3
Difficult to Open or Close
3
3
Defective Device
3
3
Insufficient Information
2
2
Device Operates Differently Than Expected
2
2
Out-Of-Box Failure
2
2
Structural Problem
2
2
Electrical /Electronic Property Problem
2
2
Device Sensing Problem
1
1
Inappropriate or Unexpected Reset
1
1
Noise, Audible
1
1
Leak/Splash
1
1
Disconnection
1
1
Fitting Problem
1
1
Device Alarm System
1
1
Crack
1
1
Therapeutic or Diagnostic Output Failure
1
1
Improper Flow or Infusion
1
1
Failure to Power Up
1
1
Protective Measures Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
14
14
No Clinical Signs, Symptoms or Conditions
10
10
No Patient Involvement
8
8
Insufficient Information
4
4
No Consequences Or Impact To Patient
4
4
No Information
2
2
Patient Problem/Medical Problem
1
1
Aneurysm
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corp.
II
May-10-2016
2
Baxter Healthcare Corporation
II
Jul-20-2023
3
Baxter Healthcare Corporation
II
Jul-29-2014
4
Escalon Medical Corp
II
Oct-22-2010
5
Medistim Asa
II
Feb-26-2018
6
Parks Medical Electronics, Inc
II
Dec-10-2012
7
Transonic Systems Inc
II
Sep-03-2015
8
Vascular Technology, Inc.
II
Sep-12-2018
9
Vascular Technology, Inc.
II
Jul-07-2014
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