Boston Scientific Corp - FDA 510(k) Cleared Devices
432
Total
411
Cleared
0
Denied
162 devices
Cleared
Jun 27, 2003
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
Gastroenterology & Urology
42d
Cleared
May 23, 2003
NAVIGATOR URETERAL ACCESS SHEATH SET
Gastroenterology & Urology
57d
Cleared
Apr 17, 2003
MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG...
Gastroenterology & Urology
30d
Cleared
Mar 25, 2003
BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
Gastroenterology & Urology
25d
Cleared
Mar 21, 2003
100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
Gastroenterology & Urology
67d
Cleared
Mar 17, 2003
MODIFICATION TO CONTOUR POLARIS URETERAL STENT
Gastroenterology & Urology
26d
Cleared
Oct 25, 2002
BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
Gastroenterology & Urology
161d
Cleared
Sep 13, 2002
URETERAL ACCESS SHEATH SET (UASS)
Gastroenterology & Urology
74d
Cleared
Sep 05, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
Gastroenterology & Urology
27d
Cleared
Aug 08, 2002
URETERAL STENT
Gastroenterology & Urology
267d
Cleared
Aug 02, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON...
Gastroenterology & Urology
200d
Cleared
Jul 09, 2002
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT
Gastroenterology & Urology
190d
Cleared
Apr 12, 2002
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS...
Gastroenterology & Urology
29d
Cleared
Nov 28, 2001
ULTRA-THIN SDS BALLOON DILATATION CATHETER
Gastroenterology & Urology
162d
Cleared
Nov 15, 2001
WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
Gastroenterology & Urology
91d
Cleared
Oct 24, 2001
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820,...
Gastroenterology & Urology
58d
Cleared
Oct 19, 2001
AUTOTOME RX MODEL # 4515, 4516
Gastroenterology & Urology
29d
Cleared
Oct 12, 2001
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM,...
Gastroenterology & Urology
45d
Cleared
Aug 24, 2001
VAXCEL DIALYSIS CATHETER
Gastroenterology & Urology
29d
Cleared
Jul 13, 2001
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
Gastroenterology & Urology
18d
Cleared
Apr 30, 2001
ALIEN RX MICRO CANNULA, MODEL 4530
Gastroenterology & Urology
27d
Cleared
Mar 27, 2001
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
Gastroenterology & Urology
26d
Cleared
Mar 22, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
Gastroenterology & Urology
92d
Cleared
Jan 22, 2001
CONTOUR POLARIS URETERAL STENT
Gastroenterology & Urology
20d
Cleared
Oct 12, 2000
NIR BILLIARY STENT SYSTEM
Gastroenterology & Urology
90d
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