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Boston Scientific Corp

85 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube. recall (Z-0402-2016)Boston Scientific Corp2015-12-10
IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM recall (Z-1209-2015)Boston Scientific Corp2015-03-02
IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog nu recall (Z-0580-2015)Boston Scientific Corp2014-12-10
RF Ablation System Foot Switch, used with the EPT-1000 RF Generator, Foot Switch Model Num recall (Z-0973-2011)Boston Scientific Corp2011-01-27
CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation System, Model Number M recall (Z-1156-2010)Boston Scientific Corp2010-03-17
Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast recall (Z-0175-2010)Boston Scientific Corp2009-11-11
Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For ti recall (Z-1876-2009)Boston Scientific Corp2009-09-09
Boston Scientific, LeVeen Needle Electrode, 25 cm, 5.0 cm, sterile; REF M001262170. For ti recall (Z-1877-2009)Boston Scientific Corp2009-09-09
Convoy Advanced Delivery Sheath Kit, Model Numbers: M0045660ST0, M0045661ST0, M0045662ST0, recall (Z-1071-2009)Boston Scientific Corp2009-04-09
Soft Tip Sheath Multipurpose Introducing Sheath Kit, Model Numbers: M00456600, M00456610, recall (Z-1072-2009)Boston Scientific Corp2009-04-09
Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 20 recall (Z-1010-2009)Boston Scientific Corp2009-03-11
Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 30 recall (Z-1011-2009)Boston Scientific Corp2009-03-11
Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 11.5 mm, 5. recall (Z-1012-2009)Boston Scientific Corp2009-03-11
Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile X recall (Z-0911-2009)Boston Scientific Corp2009-01-28
Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile Xyl recall (Z-0912-2009)Boston Scientific Corp2009-01-28
Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free, sterile, recall (Z-0913-2009)Boston Scientific Corp2009-01-28
Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with pre-fille recall (Z-0914-2009)Boston Scientific Corp2009-01-28
RF Ablation System Foot Switch. (Can be used with Boston Scientific Maestro 3000 and EPT-1 recall (Z-0858-2009)Boston Scientific Corp2009-01-14
Boston Scientific Easy Core Biopsy Device, 18 ga. x 21 cm, sterile, latex free. Boston Sci recall (Z-0487-2009)Boston Scientific Corp2009-01-12
Boston Scientific Easy Core Biopsy Device, 18 ga. x 15 cm, sterile, latex free. Boston Sci recall (Z-0488-2009)Boston Scientific Corp2009-01-12
Boston Scientific Easy Core Biopsy Device, 15 ga. x 15 cm, sterile, latex free. Boston Sci recall (Z-0489-2009)Boston Scientific Corp2009-01-12
Boston Scientific Easy Core Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston Sci recall (Z-0490-2009)Boston Scientific Corp2009-01-12
Boston Scientific TruPath Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston Scien recall (Z-0491-2009)Boston Scientific Corp2009-01-12
Boston Scientific TruPath Biopsy Device, 18 ga. x 15 cm, sterile, latex free. Boston Scien recall (Z-0492-2009)Boston Scientific Corp2009-01-12
Boston Scientific TruPath Biopsy Device, 18 ga. x 21 cm, sterile, latex free. Boston Scien recall (Z-0493-2009)Boston Scientific Corp2009-01-12
Boston Scientific Easy Core Biopsy System, 15 ga. x 15 cm, sterile, latex free. Boston Sci recall (Z-0494-2009)Boston Scientific Corp2009-01-12
Boston Scientific Easy Core Biopsy System, 18 ga. x 15 cm, sterile, latex free. Boston Sci recall (Z-0495-2009)Boston Scientific Corp2009-01-12
Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile. The device is recall (Z-2091-2008)Boston Scientific Corp2008-09-16
Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile. The device is recall (Z-2092-2008)Boston Scientific Corp2008-09-16
Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/15 cm, sterile. The device is recall (Z-2093-2008)Boston Scientific Corp2008-09-16
Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/25 cm, sterile. The device is recall (Z-2094-2008)Boston Scientific Corp2008-09-16
Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile, Boston Scienti recall (Z-1913-2008)Boston Scientific Corp2008-09-11
Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile, Boston Scienti recall (Z-1914-2008)Boston Scientific Corp2008-09-11
Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/15 cm, sterile, Boston Scienti recall (Z-1915-2008)Boston Scientific Corp2008-09-11
Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/25 cm, sterile, Boston Scienti recall (Z-1916-2008)Boston Scientific Corp2008-09-11
Boston Scientific Flexima Biliary Stent System, 200 cm long, .035" (0.89 mm), sterile, Bos recall (Z-2105-2008)Boston Scientific Corp2008-09-11
Boston Scientific SteeroCath-T Ablation Catheter. This catheter is indicated for general i recall (Z-1617-2008)Boston Scientific Corp2008-08-30
Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific Cor recall (Z-1618-2008)Boston Scientific Corp2008-08-30
Boston Scientific ACCUSTICK II Introducer System with .038 inch Stainless Steel J Tip and recall (Z-0328-2008)Boston Scientific Corp2007-12-07
Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0 recall (Z-1191-2007)Boston Scientific Corp2007-08-22
Vaxcel Implantable Vascular Access System -Titanium Standard Port With 9F Polyurethane Cat recall (Z-0745-2007)Boston Scientific Corp2007-04-14
Vaxcel Implantable Vascular Access System - Plastic Standard Port With 9F Polyurethane Cat recall (Z-0746-2007)Boston Scientific Corp2007-04-14
Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Poly recall (Z-0630-2007)Boston Scientific Corp2007-03-15
Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Sili recall (Z-0631-2007)Boston Scientific Corp2007-03-15
Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; R recall (Z-0081-2007)Boston Scientific Corp2006-10-28
Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneou recall (Z-1499-06)Boston Scientific Corp2006-09-13
Boston Scientific Vesica Sling Kits with Drill-In Anchor System sterile, for single use on recall (Z-1308-06)Boston Scientific Corp2006-08-02
Boston Scientific Vesica Drill-In Bone Locator; sterile, single use only; REF/Catalog no. recall (Z-1309-06)Boston Scientific Corp2006-08-02
Boston Scientific Urovac Bladder Evacuator, sterile, single use only; REF/Catalog no. 730- recall (Z-1300-06)Boston Scientific Corp2006-07-27
Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-3 recall (Z-1238-06)Boston Scientific Corp2006-07-13
Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, distal balloo recall (Z-1109-06)Boston Scientific Corp2006-06-27
Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, distal balloo recall (Z-1110-06)Boston Scientific Corp2006-06-27
Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 20 mm cut wire, proximal ballo recall (Z-1111-06)Boston Scientific Corp2006-06-27
Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, proximal ball recall (Z-1112-06)Boston Scientific Corp2006-06-27
Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 30 mm cut wire, proximal ballo recall (Z-1113-06)Boston Scientific Corp2006-06-27
Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, proximal ball recall (Z-1114-06)Boston Scientific Corp2006-06-27
Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 90 cm, 1.9 Fr., st recall (Z-0510-06)Boston Scientific Corp2006-02-08
Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 120 cm, 1.9 Fr., s recall (Z-0511-06)Boston Scientific Corp2006-02-08
Chilli II Cooled Ablation Cathether, Model M00490310 recall (Z-0473-06)Boston Scientific Corp2006-02-04
Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 220 cm, package recall (Z-0376-06)Boston Scientific Corp2006-01-11
Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 90 cm, package o recall (Z-0377-06)Boston Scientific Corp2006-01-11
Boston Scientific brand LeVeen Needle Electrode, 5.0/13/15; Model number M001262160, Ref 2 recall (Z-1541-05)Boston Scientific Corp2005-09-14
Boston Scientific brand LeVeen Needle Electrode, 5.0/13/25; Model number M001262170,Ref 26 recall (Z-1542-05)Boston Scientific Corp2005-09-14
Boston Scientific brand Concerto Bipolar Needle Electrode, sterile, latex free, Model M001 recall (Z-1456-05)Boston Scientific Corp2005-08-31
''NAMIC Custom Angiographic Kit'' sold under the following labels: (1) Medical University recall (Z-1393-05)Boston Scientific Corp2005-08-24
EMCEE OBTURATOR (7F) for use with 8F Sheath, REF #92580008, packaged in individual labeled recall (Z-1021-05)Boston Scientific Corp2005-07-20
Boston Scientific brand Low Profile PEG (percutaneous endoscopic gastrostomy tubes) Kit, 1 recall (Z-0962-05)Boston Scientific Corp2005-07-07
Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 20 F recall (Z-0963-05)Boston Scientific Corp2005-07-07
Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 20 F recall (Z-0964-05)Boston Scientific Corp2005-07-07
Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 24 F recall (Z-0965-05)Boston Scientific Corp2005-07-07
Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 24 F recall (Z-0966-05)Boston Scientific Corp2005-07-07
Boston Scientific brand pull Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit, recall (Z-0967-05)Boston Scientific Corp2005-07-07
Boston Scientific brand pull Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit, recall (Z-0968-05)Boston Scientific Corp2005-07-07
Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 1 recall (Z-0969-05)Boston Scientific Corp2005-07-07
Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 2 recall (Z-0970-05)Boston Scientific Corp2005-07-07
Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 2 recall (Z-0971-05)Boston Scientific Corp2005-07-07
Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 2 recall (Z-0972-05)Boston Scientific Corp2005-07-07
NAMIC Custom Angiographic Kit, Left Heart Kit - . Model #H749651947220. Catalog # 65194722 recall (Z-0302-05)Boston Scientific Corp2004-12-09
NAMIC Custom Angiographic Kit, Left Heart Kit. - . Model #: H7496019054110. Catalog #60190 recall (Z-0303-05)Boston Scientific Corp2004-12-09
Product in clear plastic pouch labeled: Boston Scientific MEDI-TECH *** VASCULAR DILATOR * recall (Z-0842-04)Boston Scientific Corp2004-07-20
Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 5 cm, sterile, single use on recall (Z-1102-04)Boston Scientific Corp2004-07-20
Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 10 cm, sterile, single use o recall (Z-1103-04)Boston Scientific Corp2004-07-20
Boston Scientific/MEDI-TECH brand Fascial Dilator, 8 FR(2.7 mm), sterile, single use only, recall (Z-1104-04)Boston Scientific Corp2004-07-20
Boston Scientific/MEDI-TECH brand Fascial Dilator, 10 FR (3.3 mm), sterile, single use onl recall (Z-1105-04)Boston Scientific Corp2004-07-20
Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter wi recall (Z-1106-04)Boston Scientific Corp2004-07-20

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Every clearance here is in the API, with alerts when new ones post.