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Numed Inc

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
49
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1754-2025Class IIBIB Balloon in Balloon Dilatation Catheter. Model Number: 420April 21, 2025
Z-0510-2019Class IIMulti-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for uOctober 17, 2018
Z-0511-2019Class IIMulti-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for uOctober 17, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K213915BIB Stent Placement CatheterJanuary 12, 2022
K211910Z-6 Atrioseptostomy CatheterJuly 19, 2021
K211134BIB Stent Placement CatheterMay 27, 2021
K190974D'Vill IntroducerMay 14, 2019
K171206D'Vill IntroducerOctober 20, 2017
K161451BIB Stent Placement CatheterSeptember 22, 2016
K160598REBOA Balloon CatheterJune 20, 2016
K160889BIB Stent Placement CatheterMay 20, 2016
K131869PTS-X SIZING BALLOON CATHETERAugust 8, 2013
K122012Z-MED Z-MED IIOctober 4, 2012
K121859TYSHAK NUCLEUSAugust 31, 2012
DEN080015NUCLEUS-X PTV CATHETERJune 11, 2012
K110903PTS-X SIZING BALLOON CATHETERApril 29, 2011
K102473MULLINS-X PTV CATHETERDecember 9, 2010
K082868MULLINS-X, MODEL 250XOctober 24, 2008
K082524MINI GHOST, MODEL: 507September 26, 2008
K081680NUCLEUS-X, MODEL 230XJuly 10, 2008
K050857BIB PTA BALLOON CATHETERJuly 28, 2005
K051343MINI GHOST PTA CATHETER, MODEL 507July 28, 2005
K040830PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERSJune 18, 2004