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
activated whole blood clotting time
Product Code
JBP
Regulation Number
864.7140
Device Class
2
Premarket Reviews
Manufacturer
Decision
SIENCO, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
26
26
2016
4
4
2017
16
16
2018
1
1
2019
15
15
2020
10
10
2021
9
9
2022
7
7
2023
17
17
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
67
67
Incorrect Or Inadequate Test Results
12
12
High Test Results
8
8
Overheating of Device
7
7
False Negative Result
5
5
False Positive Result
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Failure to Charge
2
2
Battery Problem
2
2
Device Operates Differently Than Expected
2
2
Device Dislodged or Dislocated
1
1
Charging Problem
1
1
Low Readings
1
1
Device Displays Incorrect Message
1
1
Break
1
1
Device Emits Odor
1
1
Off-Label Use
1
1
Smoking
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
24
24
No Clinical Signs, Symptoms or Conditions
23
23
No Information
18
18
Chest Pain
11
11
No Code Available
6
6
No Consequences Or Impact To Patient
5
5
Hemorrhage/Bleeding
4
4
Myocardial Infarction
4
4
Pain
3
3
Atrial Fibrillation
3
3
Angina
2
2
Peripheral Vascular Disease
2
2
Ventricular Tachycardia
2
2
ST Segment Elevation
1
1
Cardiomyopathy
1
1
Cellulitis
1
1
Cardiac Enzyme Elevation
1
1
Nausea
1
1
Shock
1
1
Respiratory Distress
1
1
Exposure to Body Fluids
1
1
Laceration(s)
1
1
Diabetic Ketoacidosis
1
1
Heart Failure/Congestive Heart Failure
1
1
Aortic Valve Stenosis
1
1
Arteriosclerosis/ Atherosclerosis
1
1
Coagulation Disorder
1
1
Dizziness
1
1
Aneurysm
1
1
High Blood Pressure/ Hypertension
1
1
Numbness
1
1
Swelling/ Edema
1
1
Hyperglycemia
1
1
Mitral Valve Prolapse
1
1
Dyspnea
1
1
Transient Ischemic Attack
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Point Of Care Inc.
II
Feb-16-2011
2
Abbott Point Of Care Inc.
II
Nov-17-2010
3
Abbott Point of Care Inc.
II
Feb-23-2010
4
International Technidyne Corp.
II
Aug-21-2009
-
-