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
device, monitoring, intracranial pressure
Product Code
GWM
Regulation Number
882.1620
Device Class
2
Premarket Reviews
Manufacturer
Decision
BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA S.A.
SUBSTANTIALLY EQUIVALENT
2
BRAINCARE DESENVOLVIMENTO E INOVAÇÃO TECNOLÓGICA S.A.
SUBSTANTIALLY EQUIVALENT
1
BRANCHPOINT TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
CMA MICRODIALYSIS AB
SUBSTANTIALLY EQUIVALENT
1
CODMAN & SHURTLEFF, INC
SUBSTANTIALLY EQUIVALENT
1
CODMAN & SHURTLEFF, INC.
SUBSTANTIALLY EQUIVALENT
1
DPCOM AS
SUBSTANTIALLY EQUIVALENT
1
HEMEDEX INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
INNERSPACE NEURO SOLUTIONS, INC.
SUBSTANTIALLY EQUIVALENT
1
INNERSPACE, INC
SUBSTANTIALLY EQUIVALENT
1
INNERSPACE, INC.
SUBSTANTIALLY EQUIVALENT
1
INTEGRA LIFESCIENCE CORPORTATION
SUBSTANTIALLY EQUIVALENT
1
INTEGRA LIFESCIENCES CORP.
SUBSTANTIALLY EQUIVALENT
2
INTEGRA LIFESCIENCES CORPORATION
SUBSTANTIALLY EQUIVALENT
2
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
SUBSTANTIALLY EQUIVALENT
2
INTRGRA LIFESCIENCES CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MEDOS INTERNATIONAL SARL
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
3
RAUMEDIC AG
SUBSTANTIALLY EQUIVALENT
5
SOPHYSA, SA
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
360
360
2015
486
486
2016
419
419
2017
439
439
2018
299
299
2019
260
260
2020
268
268
2021
211
211
2022
424
424
2023
746
746
2024
475
475
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
775
775
Break
494
494
Incorrect, Inadequate or Imprecise Result or Readings
466
466
Disconnection
391
391
Device Operates Differently Than Expected
254
254
Fracture
252
252
Device Displays Incorrect Message
192
192
Output Problem
168
168
Appropriate Term/Code Not Available
120
120
Leak/Splash
111
111
Unable to Obtain Readings
107
107
Low Readings
107
107
Incorrect Measurement
106
106
High Readings
99
99
Adverse Event Without Identified Device or Use Problem
91
91
Electrical /Electronic Property Problem
88
88
Use of Device Problem
78
78
Connection Problem
77
77
Device Operational Issue
70
70
Failure to Zero
70
70
Insufficient Information
70
70
Display or Visual Feedback Problem
66
66
Loose or Intermittent Connection
59
59
False Reading From Device Non-Compliance
57
57
Device Sensing Problem
56
56
Infusion or Flow Problem
54
54
No Display/Image
52
52
No Device Output
49
49
Device Inoperable
43
43
Device Dislodged or Dislocated
41
41
Failure to Read Input Signal
39
39
Defective Device
35
35
Complete Blockage
32
32
Improper Device Output
29
29
Signal Artifact/Noise
28
28
Failure to Power Up
28
28
Crack
27
27
Pressure Problem
27
27
Communication or Transmission Problem
26
26
Bent
23
23
Failure to Sense
22
22
Image Display Error/Artifact
20
20
Device Handling Problem
19
19
Defective Component
17
17
Occlusion Within Device
17
17
Difficult to Insert
17
17
Detachment Of Device Component
17
17
Battery Problem
17
17
Mechanical Problem
17
17
Mechanical Jam
16
16
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1482
1482
No Known Impact Or Consequence To Patient
1219
1219
No Information
499
499
No Consequences Or Impact To Patient
447
447
Insufficient Information
181
181
No Patient Involvement
172
172
No Code Available
119
119
Cerebrospinal Fluid Leakage
79
79
Failure of Implant
75
75
Injury
71
71
Unspecified Infection
57
57
Death
43
43
Device Embedded In Tissue or Plaque
30
30
Hematoma
23
23
Hemorrhage/Bleeding
21
21
Unspecified Tissue Injury
21
21
Complaint, Ill-Defined
18
18
Bacterial Infection
18
18
Foreign Body In Patient
15
15
Headache
15
15
Intracranial Hemorrhage
13
13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
Fever
12
12
Patient Problem/Medical Problem
10
10
Therapeutic Response, Decreased
10
10
Not Applicable
8
8
Neurological Deficit/Dysfunction
8
8
Brain Injury
6
6
Coma
6
6
Hydrocephalus
6
6
Vomiting
5
5
Hernia
4
4
Pain
4
4
Head Injury
4
4
Ambulation Difficulties
4
4
High Blood Pressure/ Hypertension
4
4
Edema
3
3
Malaise
3
3
Hemorrhage, Cerebral
3
3
Test Result
3
3
Hemorrhage, Subarachnoid
3
3
Therapeutic Effects, Unexpected
3
3
Meningitis
3
3
Swelling/ Edema
2
2
Aneurysm
2
2
Tissue Damage
2
2
Fall
2
2
Convulsion/Seizure
2
2
Pulmonary Embolism
2
2
Paralysis
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Codman & Shurtleff, Inc.
II
Mar-22-2012
2
Codman & Shurtleff, Inc.
II
Jan-11-2012
3
Codman & Shurtleff, Inc.
II
Apr-20-2011
4
Integra LifeSciences Corp
III
Feb-03-2012
5
Integra LifeSciences Corp.
I
Dec-14-2023
6
Integra LifeSciences Corp.
II
May-19-2023
7
Integra LifeSciences Corp.
I
Jul-22-2022
8
Integra LifeSciences Corp.
II
Oct-12-2019
9
Integra LifeSciences Corp.
II
Jun-18-2015
10
Integra LifeSciences Corp.
II
May-15-2015
11
Integra LifeSciences Corp.
II
Dec-18-2014
12
Integra LifeSciences Corp.
II
Nov-10-2014
13
Integra LifeSciences Corp.
II
May-30-2014
14
Integra LifeSciences Corp.
II
Dec-27-2013
15
Integra LifeSciences Corp.
II
Oct-23-2013
16
Integra LifeSciences Corp.
II
Mar-03-2011
17
Integra LifeSciences Corp.
II
Oct-28-2010
18
Integra LifeSciences Corp.
II
Apr-20-2010
19
Integra Limited
II
Oct-30-2013
20
Sophysa S.A.
II
May-15-2024
21
Spiegelberg Gmbh & Co. KG
II
Sep-26-2016
-
-