Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

50 results for "NuMED, Inc."
1–24 of 50
Search insights Median review: 50d Cleared: 98% Top manufacturer: NuMED, Inc. Lead specialty: Cardiovascular
Cleared Jan 12, 2022
BIB Stent Placement Catheter
K213915 · NVM
NuMED, Inc.
Cardiovascular · 28d
Cleared Jul 19, 2021
Z-6 Atrioseptostomy Catheter
K211910 · DXF
NuMED, Inc.
Cardiovascular · 28d
Cleared May 27, 2021
BIB Stent Placement Catheter
K211134 · NVM
NuMED, Inc.
Cardiovascular · 41d
Cleared May 14, 2019
D'Vill Introducer
K190974 · DYB
NuMED, Inc.
Cardiovascular · 29d
Cleared Oct 20, 2017
D'Vill Introducer
K171206 · DYB
NuMED, Inc.
Cardiovascular · 178d
Cleared Sep 22, 2016
BIB Stent Placement Catheter
K161451 · NVM
NuMED, Inc.
Cardiovascular · 119d
Cleared Jun 20, 2016
REBOA Balloon Catheter
K160598 · MJN
NuMED, Inc.
Cardiovascular · 110d
Cleared May 20, 2016
BIB Stent Placement Catheter
K160889 · NVM
NuMED, Inc.
Cardiovascular · 50d
Cleared Aug 08, 2013
PTS-X SIZING BALLOON CATHETER
K131869 · MJN
NuMED, Inc.
Cardiovascular · 45d
Cleared Oct 04, 2012
Z-MED Z-MED II
K122012 · OZT
NuMED, Inc.
Cardiovascular · 86d
Cleared Aug 31, 2012
TYSHAK NUCLEUS
K121859 · DQY
NuMED, Inc.
Cardiovascular · 66d
Not Cleared Jun 11, 2012
NUCLEUS-X PTV CATHETER
DEN080015 · OZT
NuMED, Inc.
Cardiovascular · 1265d
Cleared Apr 29, 2011
PTS-X SIZING BALLOON CATHETER
K110903 · MJN
NuMED, Inc.
Cardiovascular · 29d
Cleared Dec 09, 2010
MULLINS-X PTV CATHETER
K102473 · OMZ
NuMED, Inc.
Cardiovascular · 101d
Cleared Oct 24, 2008
MULLINS-X, MODEL 250X
K082868 · DQY
NuMED, Inc.
Cardiovascular · 25d
Cleared Sep 26, 2008
MINI GHOST, MODEL: 507
K082524 · DQY
NuMED, Inc.
Cardiovascular · 24d
Cleared Jul 10, 2008
NUCLEUS-X, MODEL 230X
K081680 · DQY
NuMED, Inc.
Cardiovascular · 23d
Cleared Jul 28, 2005
MINI GHOST PTA CATHETER, MODEL 507
K051343 · DQY
NuMED, Inc.
Cardiovascular · 66d
Cleared Jul 28, 2005
BIB PTA BALLOON CATHETER
K050857 · NVM
NuMED, Inc.
Cardiovascular · 114d
Cleared Jun 18, 2004
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K040830 · DQO
NuMED, Inc.
Cardiovascular · 79d
Cleared Jun 10, 2004
NUMED PTS X SIZING BALLOON CATHETER
K041306 · MJN
NuMED, Inc.
Cardiovascular · 24d
Cleared May 06, 2004
NUMED MULLINS X PTA CATHETER
K041093 · DQY
NuMED, Inc.
Cardiovascular · 9d
Cleared Sep 25, 2003
NUMED TYSHAK MINI PEDIATRIC PTV CATHETER
K032591 · DQY
NuMED, Inc.
Cardiovascular · 34d
Cleared May 21, 2003
MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS
K030589 · DQY
NuMED, Inc.
Cardiovascular · 85d