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TPLC
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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
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
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