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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, monitoring, intracranial pressure
Product CodeGWM
Regulation Number 882.1620
Device Class 2


Premarket Reviews
ManufacturerDecision
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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