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Boston Scientific

51 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UP recall (Z-1729-2020)Boston Scientific2020-04-01
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: recall (Z-1730-2020)Boston Scientific2020-04-01
Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UP recall (Z-1731-2020)Boston Scientific2020-04-01
Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN recall (Z-1732-2020)Boston Scientific2020-04-01
Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110 recall (Z-1733-2020)Boston Scientific2020-04-01
Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110 recall (Z-1734-2020)Boston Scientific2020-04-01
Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13 recall (Z-1735-2020)Boston Scientific2020-04-01
Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080 recall (Z-1736-2020)Boston Scientific2020-04-01
Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080 recall (Z-1737-2020)Boston Scientific2020-04-01
Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080 recall (Z-1738-2020)Boston Scientific2020-04-01
Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080 recall (Z-1739-2020)Boston Scientific2020-04-01
Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080 recall (Z-1740-2020)Boston Scientific2020-04-01
Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen c recall (Z-0935-2008)Boston Scientific2008-01-31
Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen c recall (Z-0936-2008)Boston Scientific2008-01-31
Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen c recall (Z-0937-2008)Boston Scientific2008-01-31
Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen c recall (Z-0938-2008)Boston Scientific2008-01-31
Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen c recall (Z-0939-2008)Boston Scientific2008-01-31
Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen c recall (Z-0940-2008)Boston Scientific2008-01-31
Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen c recall (Z-0941-2008)Boston Scientific2008-01-31
Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen c recall (Z-0942-2008)Boston Scientific2008-01-31
Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen c recall (Z-0943-2008)Boston Scientific2008-01-31
Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen c recall (Z-0944-2008)Boston Scientific2008-01-31
Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen c recall (Z-0945-2008)Boston Scientific2008-01-31
Boston Scientific mach 1 Guide Catheter, 8F, FCL 3.5 SH Femoral Curve Left 3.5, REF 34358- recall (Z-0103-2008)Boston Scientific2007-10-27
Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left 3.5, REF 34358-78, UPN H749343 recall (Z-0104-2008)Boston Scientific2007-10-27
Boston Scientific Medi-Tech Stainless Steel Greenfield Vena Cava Filter, order #50-400, lo recall (Z-0794-2007)Boston Scientific2007-05-10
Boston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, for the infusion of therapeutic recall (Z-0642-2007)Boston Scientific2007-03-21
Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Internal Mammary Cu recall (Z-0382-2007)Boston Scientific2007-02-07
Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Voda Left Curve, UP recall (Z-0383-2007)Boston Scientific2007-02-07
Boston Scientific Mach 1 Guide Catheter Femoral Approach, 7F, 0.081'', Multipurpose Curve, recall (Z-0384-2007)Boston Scientific2007-02-07
Boston Scientific Mach 1 Guide Catheter Femoral Approach, 8F, 0.091'', Amplatz Right Curve recall (Z-0385-2007)Boston Scientific2007-02-07
Boston Scientific Mach 1 Guide Catheter Femoral Approach, 8F, 0.091'', Amplatz Left Curve, recall (Z-0386-2007)Boston Scientific2007-02-07
Boston Scientific Mach 1 Guide Catheter Femoral Approach, 7F, 0.081'', Voda Left Curve, UP recall (Z-0387-2007)Boston Scientific2007-02-07
Boston Scientific Mach 1 Peripheral Guide Catheter, 6F, 55cm, LIMA Tip Shape, UPN # M00119 recall (Z-0388-2007)Boston Scientific2007-02-07
Boston Scientific PT2 Light Support Guide Wire 185cm J-Tip, Catalog Number 38931-01. Sold recall (Z-1538-06)Boston Scientific2006-09-29
Boston Scientific PT2 Light Support Guide Wire 300cm J-Tip, Catalog Number 38931-02 . Sold recall (Z-1539-06)Boston Scientific2006-09-29
Boston Scientific PT2 Moderate Support Guide Wire 185cm J-Tip, Catalog Number 38931-03 . S recall (Z-1540-06)Boston Scientific2006-09-29
Boston Scientific PT2 Moderate Support Guide Wire 300cm J-Tip, Catalog Number 38931-04. So recall (Z-1541-06)Boston Scientific2006-09-29
Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Sc recall (Z-1512-06)Boston Scientific2006-09-23
Boston Scientific IQ Guide Wire. Catalog No. 38950-010, 185 cm, Straight Tip, Single Pack. recall (Z-1213-06)Boston Scientific2006-07-12
Boston Scientific IQ Guide Wire. Catalog No. 38950-01J0, 185 cm, J-Tip, Single Pack. Steri recall (Z-1214-06)Boston Scientific2006-07-12
Boston Scientific IQ Guide Wire. Catalog No. 38950-020, 300 cm, Straight Tip, Single Pack. recall (Z-1215-06)Boston Scientific2006-07-12
Boston Scientific IQ Guide Wire. Catalog No. 38950-02J0, 300 cm, J-Tip, Single Pack. Catal recall (Z-1216-06)Boston Scientific2006-07-12
Boston Scientific IQ Guide Marker Wire. Catalog No. 38951-010, 185 cm, Straight Tip, Singl recall (Z-1217-06)Boston Scientific2006-07-12
Boston Scientific IQ Guide Marker Wire. Catalog No. 38951-01J0, 185 cm, J-Tip, Single Pack recall (Z-1218-06)Boston Scientific2006-07-12
Boston Scientific Wiseguide Guide Catheter 7F, .076 '', Femoral Approach, Manufactured for recall (Z-1102-06)Boston Scientific2006-06-10
Stainless Steel Greenfield Vena Cava Filter with 12 Fr / 4,0 mm FlexCarrier Capsule. For F recall (Z-0280-06)Boston Scientific2005-12-20
Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (R recall (Z-0112-06)Boston Scientific2005-11-01
Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Positio recall (Z-0064-06)Boston Scientific2005-10-19
Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075 recall (Z-0639-05)Boston Scientific2005-03-18
PeriVac brand Pericardial Fluid Aspiration Procedure Kit (Pericardiocentensis Kit), with P recall (Z-0071-04)Boston Scientific2003-10-30

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