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Boston Scientific Corporation

890 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxi recall (Z-0031-2009)Boston Scientific Corporation2008-10-02
iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston Scientifi recall (Z-1693-2008)Boston Scientific Corporation2008-09-23
Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917511, Ca recall (Z-2362-2008)Boston Scientific Corporation2008-09-21
Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917521, Ca recall (Z-2363-2008)Boston Scientific Corporation2008-09-21
Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917531, Ca recall (Z-2364-2008)Boston Scientific Corporation2008-09-21
Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917541, Ca recall (Z-2365-2008)Boston Scientific Corporation2008-09-21
iReview" Software (Accessory To) iLab Ultrasound Imaging System, Model Number: H7490001801 recall (Z-2006-2008)Boston Scientific Corporation2008-09-17
EndoVive Safety PEG Kits 24 F Universal Product Number (UPN): MOO56648 1 The product provi recall (Z-2236-2008)Boston Scientific Corporation2008-09-17
EndoVive Safety PEG Kits 20 F Universal Product Number (UPN): MOO566460 The product provid recall (Z-2237-2008)Boston Scientific Corporation2008-09-17
Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm REF 38928-1530 L recall (Z-2165-2008)Boston Scientific Corporation2008-08-26
Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm Made in recall (Z-2166-2008)Boston Scientific Corporation2008-08-26
Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System. recall (Z-2141-2008)Boston Scientific Corporation2008-08-13
Boston Scientific Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm, .070 in (internal di recall (Z-1300-2008)Boston Scientific Corporation2008-05-07
Boston Scientific Mach 1 peripheral Guide Catheter 6F, HS Hockey Stick, .070 in (internal recall (Z-1301-2008)Boston Scientific Corporation2008-05-07
Boston Scientific Mach 1 peripheral Guide Catheter 6F, MP Multipurpose 90cm, .070 in (inte recall (Z-1302-2008)Boston Scientific Corporation2008-05-07
Boston Scientific Mach 1 peripheral Guide Catheter 6F, RDC Renal double Curve, .070 in (in recall (Z-1303-2008)Boston Scientific Corporation2008-05-07
Boston Scientific Mach 1 peripheral Guide Catheter 7F, MP Multipurpose, .081 in (internal recall (Z-1304-2008)Boston Scientific Corporation2008-05-07
Boston Scientific Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve, .091 in (in recall (Z-1305-2008)Boston Scientific Corporation2008-05-07
Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Num recall (Z-0905-2008)Boston Scientific Corporation2008-04-30
Pathway Balloon Expandable Ureteral Access Sheath- 11/14/36, Ureteral dilator, Catalog Num recall (Z-0906-2008)Boston Scientific Corporation2008-04-30
Pathway Balloon Expandable Ureteral Access Sheath- 11/14/46, Ureteral dilator, Catalog Num recall (Z-0907-2008)Boston Scientific Corporation2008-04-30
Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator, Catalog Num recall (Z-0908-2008)Boston Scientific Corporation2008-04-30
Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator, Catalog Num recall (Z-0909-2008)Boston Scientific Corporation2008-04-30
Pathway Balloon Expandable Ureteral Access Sheath- 13/16/46, Ureteral dilator, Catalog Num recall (Z-0910-2008)Boston Scientific Corporation2008-04-30
Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator, Catalog Num recall (Z-0911-2008)Boston Scientific Corporation2008-04-30
Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog Num recall (Z-0912-2008)Boston Scientific Corporation2008-04-30
Pathway Balloon Expandable Ureteral Access Sheath- 12/15/46, Ureteral dilator, Catalog Num recall (Z-0913-2008)Boston Scientific Corporation2008-04-30
Boston Scientific, Imager II Angiographic Catheter, (Outer Carton Label): UPN M001315081, recall (Z-0279-2008)Boston Scientific Corporation2007-12-06
Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catal recall (Z-0109-2008)Boston Scientific Corporation2007-10-31
Boston Scientific Radial Jaw Large Capacity Biopsy Forceps, Sterile, 240 mm. Box of 20 U P recall (Z-0116-2008)Boston Scientific Corporation2007-10-31
Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. B recall (Z-0117-2008)Boston Scientific Corporation2007-10-31
Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. B recall (Z-0118-2008)Boston Scientific Corporation2007-10-31
Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391022, (5-Pack Carton L recall (Z-1159-2007)Boston Scientific Corporation2007-08-09
Boston Scientific Impulse Flextrusion Shaft 5F FL4 16391-22 H74916391222, (5-Pack Carton L recall (Z-1160-2007)Boston Scientific Corporation2007-08-09
Boston Scientific NexStent Monorail 5F Carotid Stent and Monorail Delivery System, Manufac recall (Z-1161-2007)Boston Scientific Corporation2007-08-09
Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064 recall (Z-0889-2007)Boston Scientific Corporation2007-06-05
HTA Console System, 110 Volt, Product Number: 56000 (HTA system is a software-controlled h recall (Z-0687-2007)Boston Scientific Corporation2007-03-31
HTA Console System, 230 Volt, English, Product Number: 560010 (HTA system is a software-co recall (Z-0688-2007)Boston Scientific Corporation2007-03-31
HTA Console System, 230 Volt, Product Number: 56001 DO- English Demonstration Evaluation U recall (Z-0689-2007)Boston Scientific Corporation2007-03-31
HTA Console System, 230 Volt , French, Product Number: 56001FO (HTA system is a software-c recall (Z-0690-2007)Boston Scientific Corporation2007-03-31
HTA Console System, 230 Volt , Italian, Product Number: 56001 IO (HTA system is a software recall (Z-0691-2007)Boston Scientific Corporation2007-03-31
Boston Scientific SpyGlass Visualization Probe Reference Number: 4603 UPN M00546030 recall (Z-0696-2007)Boston Scientific Corporation2007-03-31
Boston Scientific SpyGlass Ocular Reference Number: 4604 UPN M00546040 recall (Z-0697-2007)Boston Scientific Corporation2007-03-31
Boston Scientific SpyGlass Light Cable Reference Number: 4621 UPN M00546210 recall (Z-0698-2007)Boston Scientific Corporation2007-03-31
Boston Scientific SpyGlass Camera Ref Number: 4610 UPN M00546100 recall (Z-0699-2007)Boston Scientific Corporation2007-03-31
Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, UPN H965430100 recall (Z-0604-2007)Boston Scientific Corporation2007-03-13
Wallstent Endoscopic Biliary Endoprosthesis 8mm x 60mm, UPN H965430200 recall (Z-0605-2007)Boston Scientific Corporation2007-03-13
Wallstent Endoscopic Biliary Endoprosthesis 8mm x 80mm, UPN H965430300 recall (Z-0606-2007)Boston Scientific Corporation2007-03-13
Wallstent Endoscopic Biliary Endoprosthesis 10mm x 40mm, UPN H965430400 recall (Z-0607-2007)Boston Scientific Corporation2007-03-13
Wallstent Endoscopic Biliary Endoprosthesis 10mm x 60mm, UPN H965430500 recall (Z-0608-2007)Boston Scientific Corporation2007-03-13
Wallstent Endoscopic Biliary Endoprosthesis 10mm x 80mm, UPN H965430600 recall (Z-0609-2007)Boston Scientific Corporation2007-03-13
Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990 recall (Z-0122-2007)Boston Scientific Corporation2006-11-01
The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon wi recall (Z-0410-06)Boston Scientific Corporation2006-02-01
The Flextome Cutting Balloon Device consists of a balloon with 3 or 4 atherotomes (microsu recall (Z-0409-06)Boston Scientific Corporation2006-01-31
Vaxcel Implantable Vascular Access System - Titanium Mini Port with 7F Polyurethane Cathet recall (Z-0340-06)Boston Scientific Corporation2006-01-06
Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston Scienti recall (Z-0341-06)Boston Scientific Corporation2006-01-06
Silicone Central Venous Catheters with PASV Valve and Polyester Cuff - 7F. Boston Scientif recall (Z-0342-06)Boston Scientific Corporation2006-01-06
Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV valve and 6.6F Silic recall (Z-0343-06)Boston Scientific Corporation2006-01-06
Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV Valve and 6.6F Silic recall (Z-0344-06)Boston Scientific Corporation2006-01-06
TLC Self -Retaining Retractor System-Single Product Code: 820-175 recall (Z-0257-06)Boston Scientific Corporation2005-12-01
TLC Self -Retaining Retractor System-5/box Product Number:820-176 recall (Z-0258-06)Boston Scientific Corporation2005-12-01
TLC Retractor and Single Step Pelvic Drape (contains 1 Product Code 820-175) Product Code: recall (Z-0259-06)Boston Scientific Corporation2005-12-01
Precision Twist Transvaginal Sling Kit with Non-Absorbable, Polybutester Monofilament Sutu recall (Z-0260-06)Boston Scientific Corporation2005-12-01
Precision Tack Transvaginal Sling Kit with Non-Absorbable, Braided Polyester Suture (conta recall (Z-0261-06)Boston Scientific Corporation2005-12-01
Capio CL Kit Transvaginal Suture Capturing Device (1TLC Retractor box ) Product Code: 831- recall (Z-0262-06)Boston Scientific Corporation2005-12-01
Precision Tack Transvaginal Sling Kit with Non-Absorbable, Polybustester Monofilament Sutu recall (Z-0263-06)Boston Scientific Corporation2005-12-01
Precision Tack Transvaginal Sling Kit with Non-Absorbable, Braided Polyester Suture (conta recall (Z-0264-06)Boston Scientific Corporation2005-12-01
Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS recall (Z-0040-06)Boston Scientific Corporation2005-10-28
Enteryx Injector Single Pack Order Number: M00572650-US and M00572630 -OUS recall (Z-0041-06)Boston Scientific Corporation2005-10-28
Hemashield Vantage Vascular Graft. Vascular graft prosthesis. recall (Z-1459-05)Boston Scientific Corporation2005-09-28
Banana Peel™ Sheaths BP/9/15 Catalog Number: 20-606 recall (Z-1461-05)Boston Scientific Corporation2005-09-02
Banana Peel™ Sheaths BP/11/15 Catalog Number: 20-607 recall (Z-1462-05)Boston Scientific Corporation2005-09-02
Banana Peel™ Sheaths BP/12/15 Catalog Number: 20-608 recall (Z-1463-05)Boston Scientific Corporation2005-09-02
Banana Peel™ Sheaths BP/14/15 Catalog Number: 20-609 recall (Z-1464-05)Boston Scientific Corporation2005-09-02
Banana Peel™ Sheaths BP/16/15 Catalog NUmber : 20-610 recall (Z-1465-05)Boston Scientific Corporation2005-09-02
Banana Peel™ Sheaths BP/9/30 Catalog Number : 20-612 recall (Z-1466-05)Boston Scientific Corporation2005-09-02
Banana Peel™ Sheaths BP/11/30 Catalog Number : 20-613 recall (Z-1467-05)Boston Scientific Corporation2005-09-02
Banana Peel™ Sheaths BP/12/30 Catalog Number : 20-614 recall (Z-1468-05)Boston Scientific Corporation2005-09-02
Banana Peel™ Sheaths BP/14/30 Catalog Number : 20-615 recall (Z-1469-05)Boston Scientific Corporation2005-09-02
Banana Peel™ Sheaths BP/16/30 Catalog Number : 20-616 recall (Z-1470-05)Boston Scientific Corporation2005-09-02
Banana Peel™ Sheaths BP/9/45 Catalog Number : 20-618 recall (Z-1471-05)Boston Scientific Corporation2005-09-02
Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Mini/T/PU/6/1.1/ recall (Z-1472-05)Boston Scientific Corporation2005-09-02
Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Mini/T/PU/8/1.6/ recall (Z-1473-05)Boston Scientific Corporation2005-09-02
Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Mini/T/PU/8/1.6/ recall (Z-1474-05)Boston Scientific Corporation2005-09-02
Vaxcel Chest Ports - Mini/T/PU/6/1.1/1.9/63 Catalog Number : 45-303 recall (Z-1475-05)Boston Scientific Corporation2005-09-02
Vaxcel Chest Ports - Mini/T/PU/7/1.3/2.2/63 Catalog Number : 45-305 recall (Z-1476-05)Boston Scientific Corporation2005-09-02
Vaxcel Chest Ports - Mini/T/S/8/1.5/2.6/63 Catalog Number : 45-310 recall (Z-1477-05)Boston Scientific Corporation2005-09-02
Vaxcel Chest Ports - Standard/T/PU/9/1.8/2.8/63 Catalog Number : 45-315 recall (Z-1478-05)Boston Scientific Corporation2005-09-02
Vaxcel Chest Ports - Standard/T/S/8/1.5/2.6/63 Catalog Number : 45-320 recall (Z-1479-05)Boston Scientific Corporation2005-09-02
Vaxcel Chest Ports - Standard/PS/S/8/1.5/2.6/63 Catalog Number : 45-340 recall (Z-1480-05)Boston Scientific Corporation2005-09-02
Vaxcel Chest Ports - Standard/PS/PU/9/1.8/2.8/63 Catalog Number : 45-360 recall (Z-1481-05)Boston Scientific Corporation2005-09-02
Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/T/PU/8/ recall (Z-1482-05)Boston Scientific Corporation2005-09-02
Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/T/S/8/1 recall (Z-1483-05)Boston Scientific Corporation2005-09-02
Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/PS/PU/8 recall (Z-1484-05)Boston Scientific Corporation2005-09-02
Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/PS/S/8/ recall (Z-1485-05)Boston Scientific Corporation2005-09-02
Vaxcel Chronic Dialysis Catheter - Catheter/PU/14/23/Plastic Catalog Number : 45-520 recall (Z-1486-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/19/Metal Catalog Number : 45-540 recall (Z-1487-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/19/Plastic Catalog Number : 45-54 recall (Z-1488-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/19/Metal Catalog Number : 45-542 recall (Z-1489-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/19/Plastic Catalog Number : 45-543 recall (Z-1490-05)Boston Scientific Corporation2005-09-02
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Every clearance here is in the API, with alerts when new ones post.