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
oximeter, reprocessed
Definition
same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product Code
NLF
Regulation Number
870.2700
Device Class
2
Premarket Reviews
Manufacturer
Decision
STRYKER SUSTAINABILITY SOLUTIONS
SUBSTANTIALLY EQUIVALENT
2
SURGICAL INSTRUMENT AND SAVINGS INC (DBA MEDLINE RENEWAL)
SUBSTANTIALLY EQUIVALENT
1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
11
11
2020
2
2
2021
1
1
2022
2
2
2023
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Defective Device
4
4
Temperature Problem
4
4
Defective Component
2
2
Patient Device Interaction Problem
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Adhesive Too Strong
2
2
Break
1
1
Unable to Obtain Readings
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Packaging Problem
1
1
Material Separation
1
1
Device Sensing Problem
1
1
Material Protrusion/Extrusion
1
1
No Device Output
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
10
10
Skin Inflammation/ Irritation
4
4
Inflammation
3
3
Burn(s)
2
2
Confusion/ Disorientation
1
1
Injury
1
1
Numbness
1
1
Insufficient Information
1
1
-
-