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FDA 510(k) Applications Submitted by THOMAS HIRTE
FDA 510(k) Number
Submission Date
Device Name
Applicant
K180068
01/09/2018
ORISE Gel
Boston Scientific
K050304
02/08/2005
FX WIRE ADVANCED MEASUREMENT GUIDEWIRE
CONMED CORP.
K140630
03/11/2014
WALLFLEX BILIARY RX STENT SYSTEM
BOSTON SCIENTIFIC
K031186
04/15/2003
LUMINEXX ENDOSCOPIC BILIARY STENT
C.R. BARD, INC.
K141584
06/13/2014
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
Boston Scientific Corporation
K171809
06/19/2017
Epic Biliary Endoscopic Stent System
Boston Scientific Corporation
K963064
08/07/1996
ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
LABORIE MEDICAL TECH CORP.
DEN150040
08/28/2015
WallFlex Biliary RX Fully Covered Stent System RMV
BOSTON SCIENTIFIC
K122660
08/31/2012
RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
Boston Scientific Corporation
K112543
09/01/2011
WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM
Boston Scientific Corporation
K173400
10/31/2017
ORISE Tissue Retractor System
Boston Scientific
K033562
11/12/2003
FASTRAC GASTRIC ACCESS PORT KIT
C.R. BARD, INC.
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