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Boston Scientific Scimed

44 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire recall (Z-0440-06)Boston Scientific Scimed2006-01-25
Mach 1 6F Kimny Guide Catheter. Catalog No. 34356-583. Sterilized with ethylene oxide gas. recall (Z-0432-06)Boston Scientific Scimed2006-01-24
Mach 1 6F JR 3.5 Guide Catheter. Catalog No. 34356-685. Sterilized with ethylene oxide gas recall (Z-0433-06)Boston Scientific Scimed2006-01-24
Stainless Steel Greenfield Vena Cava Filter with 12 Fr. / 4,0 mm FlexCarrier Capsule. Cata recall (Z-0299-06)Boston Scientific Scimed2005-12-23
Titanium Greenfield Vena Cava Filter with 12 Fr./4,0 mm Introducer System. Catalog no. M00 recall (Z-0300-06)Boston Scientific Scimed2005-12-23
PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M0020001938 recall (Z-0931-05)Boston Scientific Scimed2005-06-25
RunWay 6F Cardiovascular Guide Catheter. recall (Z-0454-05)Boston Scientific Scimed2005-01-28
WALLSTENT Endoprostheses with UNISTEP Plus Delivery System. recall (Z-1340-04)Boston Scientific Scimed2004-08-13
Impulse 5F 145 (degree) Multipack Angiographic Catheters, Catalog Number H749163913011 recall (Z-0729-04)Boston Scientific Scimed2004-07-20
TAXUS Express Paclitaxel-Eluting MONORAIL Coronary Stent System (3.5 x 32mm). On August 5, recall (Z-1052-04)Boston Scientific Scimed2004-07-20
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip recall (Z-0030-04)Boston Scientific Scimed2003-10-15
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip recall (Z-0031-04)Boston Scientific Scimed2003-10-15
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Ti recall (Z-0032-04)Boston Scientific Scimed2003-10-15
Boston Scientific Medi-Tech Imager II 5F Selective Angiographic Catheter recall (Z-1189-03)Boston Scientific Scimed2003-08-29
Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm / 1.5 cm /90 cm (balloon width recall (Z-1096-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference Catalo recall (Z-1097-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/90 cm, Reference Catal recall (Z-1098-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/ 2.0 cm/90 cm, Reference Catal recall (Z-1099-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/90 cm, Reference Catal recall (Z-1100-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.5 mm/ 2.0 cm/90 cm, Reference Catal recall (Z-1101-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 1.5 cm/90 cm, Reference Catal recall (Z-1102-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 2.0 cm/90 cm, Reference Catal recall (Z-1103-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/ 1.5 cm/150 cm, Reference Cata recall (Z-1104-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/ 2.0 cm/150 cm, Reference Cata recall (Z-1105-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/150 cm, Reference Cata recall (Z-1106-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 2.0 cm/150 cm, Reference Cata recall (Z-1107-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/ 1.5 cm/150 cm, Reference Cata recall (Z-1108-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.5 mm/ 2.0 cm/150 cm, Reference Cata recall (Z-1109-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/150 cm, Reference Cata recall (Z-1110-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.5 mm/ 1.5 cm/150 cm, Reference Cata recall (Z-1111-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 2.0 cm/150 cm, Reference Cata recall (Z-1112-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/2.0 cm/150 cm, Reference Catal recall (Z-1113-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/2.0 cm/150 cm, Reference Catal recall (Z-1114-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/1.5 cm/90 cm, Reference Catalo recall (Z-1115-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference Catalo recall (Z-1116-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/1.5 cm/90 cm, Reference Catalo recall (Z-1117-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/2.0 cm/90 cm, Reference Catalo recall (Z-1118-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/2.0 cm/90 cm, Reference Catalo recall (Z-1119-03)Boston Scientific Scimed2003-08-12
Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/2.0 cm/90 cm, Reference Catalo recall (Z-1120-03)Boston Scientific Scimed2003-08-12
Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog recall (Z-1123-03)Boston Scientific Scimed2003-08-12
Boston Scientific Scimed Radius Monorail 4.0 mm x 31 mm Stent Systems, Catalog Number H749 recall (Z-0776-03)Boston Scientific Scimed2003-04-22
Boston Scientific Scimed Radius 3.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the recall (Z-0777-03)Boston Scientific Scimed2003-04-22
Boston Scientific Scimed Radius 4.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the recall (Z-0778-03)Boston Scientific Scimed2003-04-22
Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Num recall (Z-0711-03)Boston Scientific Scimed2003-04-09

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