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
perineometer
Product Code
HIR
Regulation Number
884.1425
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADVANCED TACTILE IMAGING INC.
SUBSTANTIALLY EQUIVALENT
1
ADVANCED TACTILE IMAGING, INC.
SUBSTANTIALLY EQUIVALENT
1
ANALYTICA LTD
SUBSTANTIALLY EQUIVALENT
1
ANALYTICA LTD.
SUBSTANTIALLY EQUIVALENT
1
APIMEDS, INC
SUBSTANTIALLY EQUIVALENT
1
BIOINFINITY (M) SDN. BHD.
SUBSTANTIALLY EQUIVALENT
1
BIOINFINITY (M)SDN.BHD.
SUBSTANTIALLY EQUIVALENT
1
KAMABRY, INC., DBA INNER PEACE FOR WOMEN
SUBSTANTIALLY EQUIVALENT
1
ORELLE CORPORATION LTD
SUBSTANTIALLY EQUIVALENT
1
PELVITAL USA, INC.
SUBSTANTIALLY EQUIVALENT
5
PLUS EV HOLDINGS DBA INTIMATE ROSE
SUBSTANTIALLY EQUIVALENT
1
RALSTON GROUP
SUBSTANTIALLY EQUIVALENT
1
REGULATORY INSIGHT, INC.
SUBSTANTIALLY EQUIVALENT
1
REMENDIUM LABS, LLC
SUBSTANTIALLY EQUIVALENT
1
RENOVIA INC.
SUBSTANTIALLY EQUIVALENT
4
X6 INNOVATIONS
SUBSTANTIALLY EQUIVALENT
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Ralston Group
II
Jul-26-2019
-
-