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Boston Scientific Corporation

890 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/23/Metal Catalog Number : 45-544 recall (Z-1491-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/23/Plastic Catalog Number : 45-54 recall (Z-1492-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/23/Metal Catalog Number : 45-546 recall (Z-1493-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/23/Plastic Catalog Number : 45-547 recall (Z-1494-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/28/Metal Catalog Number : 45-548 recall (Z-1495-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/28/Plastic Catalog Number : 45-54 recall (Z-1496-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/28/Metal Catalog Number : 45-550 recall (Z-1497-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/28/Plastic Catalog Number : 45-551 recall (Z-1498-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/37/Metal Catalog Number : 45-552 recall (Z-1499-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/37/Plastic Catalog Number : 45-55 recall (Z-1500-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters -Kit/CPU/15/37/Metal Catalog Number: 45-554 recall (Z-1501-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/37/Plastic Catalog Number: 45-555 recall (Z-1502-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/50/Metal Catalog Number: 45-556 recall (Z-1503-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/50/Plastic Catalog Number: 45-557 recall (Z-1504-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/50/Metal Catalog Number: 45-558 recall (Z-1505-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/50/Plastic Catalog Number: 45-559 recall (Z-1506-05)Boston Scientific Corporation2005-09-02
Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC recall (Z-1507-05)Boston Scientific Corporation2005-09-02
Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC recall (Z-1508-05)Boston Scientific Corporation2005-09-02
Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC recall (Z-1509-05)Boston Scientific Corporation2005-09-02
Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC recall (Z-1510-05)Boston Scientific Corporation2005-09-02
Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC recall (Z-1511-05)Boston Scientific Corporation2005-09-02
Implantable Chest Ports With PASV Valve Technology - Single Lumen - PASV Port/6.6/SL/T/A C recall (Z-1512-05)Boston Scientific Corporation2005-09-02
Implantable Chest Ports With PASV Valve Technology -Single Lumen - PASV Port/6.6/SL/T/PA C recall (Z-1513-05)Boston Scientific Corporation2005-09-02
Implantable Chest Ports With PASV Valve Technology - Single Lumen - PASV Port/9.6/SL/T/A C recall (Z-1514-05)Boston Scientific Corporation2005-09-02
Implantable Chest Ports With PASV Valve Technology - Single Lumen - PASV Port/9.6/SL/T/PA recall (Z-1515-05)Boston Scientific Corporation2005-09-02
Implantable Chest Ports With PASV Valve Technology - Dual Lumen - PASV Port/10/DL/T/A Cata recall (Z-1516-05)Boston Scientific Corporation2005-09-02
Implantable Chest Ports With PASV Valve Technology - Dual Lumen - PASV Port/10/DL/T/PA Cat recall (Z-1517-05)Boston Scientific Corporation2005-09-02
Banana Peel™ Sheaths - 11/30 Catalog Number: 260201 recall (Z-1518-05)Boston Scientific Corporation2005-09-02
Banana Peel™ Sheaths - 12/30 Catalog Number: 260202 recall (Z-1519-05)Boston Scientific Corporation2005-09-02
Banana Peel™ Sheaths - 14/30 Catalog Number: 260203 recall (Z-1520-05)Boston Scientific Corporation2005-09-02
Banana Peel™ Sheaths - 16/30 Catalog Number: 260204 recall (Z-1521-05)Boston Scientific Corporation2005-09-02
Banana Peel™ Sheaths - 9/45 Catalog Number: 260300 recall (Z-1522-05)Boston Scientific Corporation2005-09-02
PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Cen recall (Z-1112-05)Boston Scientific Corporation2005-08-10
PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CK, Material Number M001PIC402CK0. recall (Z-1049-05)Boston Scientific Corporation2005-07-28
PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKIR, Material Number M001PIC402CKI recall (Z-1050-05)Boston Scientific Corporation2005-07-28
PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKMS, Material Number M001PIC402CKM recall (Z-1051-05)Boston Scientific Corporation2005-07-28
PICC Custom Kit GENESIS MEDICAL CENTER, 4.5F Dual Lumen , Catalog #60M120522. UPN M00160M1 recall (Z-1052-05)Boston Scientific Corporation2005-07-28
Vaxcel Plastic Low Profile Port (non-valved) chest port, with 6Fr Polyurethane Catheter, C recall (Z-0944-05)Boston Scientific Corporation2005-06-30
Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Silicone Catheter, Catalog #4 recall (Z-0945-05)Boston Scientific Corporation2005-06-30
Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Polyurethane Catheter, Catalo recall (Z-0946-05)Boston Scientific Corporation2005-06-30
Vaxcel Low Profile Port with PASV Valve and 6F Polyurethane Catheter. CATALOG NO. 45-233. recall (Z-0780-05)Boston Scientific Corporation2005-04-28
Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. CATALOG NO. 45-236, Ref. recall (Z-0781-05)Boston Scientific Corporation2005-04-28
Vaxcel Low Profile Port with PASV valve and 8F Polyurethane Catheter. CATALOG NO. 45-238, recall (Z-0782-05)Boston Scientific Corporation2005-04-28
VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen. Catalog #45-450, UPN recall (Z-0403-05)Boston Scientific Corporation2005-01-20
VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catal recall (Z-0404-05)Boston Scientific Corporation2005-01-20
VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catal recall (Z-0405-05)Boston Scientific Corporation2005-01-20
VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in kits, Catalo recall (Z-0406-05)Boston Scientific Corporation2005-01-20
VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen: CUSTOM KIT - GENESIS recall (Z-0407-05)Boston Scientific Corporation2005-01-20
PASV PICC CUSTOM KIT, 3F, single lumen - CHILDREN''S HEALTHCARE OF ATLANTA, Catalog # 60M1 recall (Z-0408-05)Boston Scientific Corporation2005-01-20
VAXCEL WITH PASV PICC, 3F, single lumen. CUSTOM KIT - UNIVERSITY OF NEW MEXICO HOSPITAL, C recall (Z-0409-05)Boston Scientific Corporation2005-01-20
PASV PICC, 3F, single lumen, CUSTOM KIT - VANDERBILT UNIVERSITY MEDICAL CENTER. Catalog #6 recall (Z-0410-05)Boston Scientific Corporation2005-01-20
Manual Biopsy Devices containing AIM system: Chiba Needle, 6 inch/15 cm, 22 gauge, Catalog recall (Z-1442-04)Boston Scientific Corporation2004-09-14
Manual Biopsy Devices containing AIM system: Chiba Needle, 8 inch/20 cm, 22 gauge, Cat. #4 recall (Z-1443-04)Boston Scientific Corporation2004-09-14
Manual Biopsy Devices containing AIM system: Crown Biopsy Needle: 6 inch/15 cm, 22 gauge, recall (Z-1444-04)Boston Scientific Corporation2004-09-14
Manual Biopsy Devices containing AIM system: Co-Axial Lung Biopsy Needle, 6 inch/15 cm, 22 recall (Z-1445-04)Boston Scientific Corporation2004-09-14
Express 2 Monorail Coronary Stent Systems (bare metal stents) - balloon expandable Express recall (Z-1121-04)Boston Scientific Corporation2004-07-27
Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm Ca recall (Z-0563-04)Boston Scientific Corporation2004-07-20
Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Mini Titanium port, Implantable P recall (Z-0731-04)Boston Scientific Corporation2004-07-20
Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD Titanium Port, Implantable Po recall (Z-0732-04)Boston Scientific Corporation2004-07-20
Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Low Profile PS port, Implantable recall (Z-0733-04)Boston Scientific Corporation2004-07-20
Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD PS port, Implantable Port Sys recall (Z-0734-04)Boston Scientific Corporation2004-07-20
VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (4 F recall (Z-0759-04)Boston Scientific Corporation2004-07-20
VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (5 F recall (Z-0760-04)Boston Scientific Corporation2004-07-20
Titanium Dual Lumen Implantable Port with PASV Valve and 10F Silicone Catheter. Catalog No recall (Z-0847-04)Boston Scientific Corporation2004-07-20
ASAP Channel Cut Biopsy System, 14 gauge Reference Number: 1250 recall (Z-1061-03)Boston Scientific Corporation2003-07-29
ASAP Channel Cut Biopsy System, 15 gauge Reference Number: 1390 recall (Z-1062-03)Boston Scientific Corporation2003-07-29
ASAP Channel Cut Biopsy System, 18 gauge Reference Number: 1394 recall (Z-1063-03)Boston Scientific Corporation2003-07-29
Fibered Platinum Coil, 0.035 Type, 4 mm x 30 mm Catalog no. 372403 recall (Z-1033-03)Boston Scientific Corporation2003-07-19
Fibered Platinum Coil, 0.035 Type, 9 mm x 60 mm Catalog no. 372906 recall (Z-1034-03)Boston Scientific Corporation2003-07-19
Wallstent Enteral Endoprothesis with Unistep Plus Delivery, 20 mm X 90 mm Catalog Number: recall (Z-1019-03)Boston Scientific Corporation2003-07-15
MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr recall (Z-0831-03)Boston Scientific Corporation2003-05-15
Polyflex Esophageal Stent 20/16mm x 90mm recall (Z-0818-03)Boston Scientific Corporation2003-05-14
Polyflex Esophageal Stent 20/16mm x 120mm recall (Z-0819-03)Boston Scientific Corporation2003-05-14
Polyflex Esophageal Stent 20/16mm x 150mm recall (Z-0820-03)Boston Scientific Corporation2003-05-14
Polyflex Esophageal Stent 23/18mm x 90mm recall (Z-0821-03)Boston Scientific Corporation2003-05-14
Polyflex Esophageal Stent 23/18mm x 120mm recall (Z-0822-03)Boston Scientific Corporation2003-05-14
Polyflex Esophageal Stent 23/18mm x 150mm recall (Z-0823-03)Boston Scientific Corporation2003-05-14
Polyflex Esophageal Stent 25/21mm x 90mm recall (Z-0824-03)Boston Scientific Corporation2003-05-14
Polyflex Esophageal Stent 25/21mm x 120mm recall (Z-0825-03)Boston Scientific Corporation2003-05-14
Polyflex Esophageal Stent 25/21mm x 150mm recall (Z-0826-03)Boston Scientific Corporation2003-05-14
Boston Scientific/Microvasive Open End Ureteral Catheter (4 Fr x 70 cm) Product Number: 40 recall (Z-0734-03)Boston Scientific Corporation2003-04-17
Boston Scientific/Microvasive Open End Ureteral Catheter (5 Fr x 70 cm) Product Number: 40 recall (Z-0735-03)Boston Scientific Corporation2003-04-17
Boston Scientific/Microvasive Open End Ureteral Catheter (7 Fr x 70 cm) Product Number: 40 recall (Z-0736-03)Boston Scientific Corporation2003-04-17
Boston Scientific/Microvasive Cone Tip Ureteral Catheter (5 Fr x 70 cm) Product Number: 40 recall (Z-0737-03)Boston Scientific Corporation2003-04-17
Boston Scientific/Microvasive Cone Tip Ureteral Catheter (6 Fr x 70 cm) Product Number: 40 recall (Z-0738-03)Boston Scientific Corporation2003-04-17
Boston Scientific/Microvasive Cone Tip Ureteral Catheter (7 Fr x 70 cm) Product Number: 40 recall (Z-0739-03)Boston Scientific Corporation2003-04-17
Boston Scientific/Microvasive Open End Ureteral Catheter (6 Fr x 70 cm) Product Number: 40 recall (Z-0740-03)Boston Scientific Corporation2003-04-17
Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/8.5 mm balloon Catalog # 45 recall (Z-0551-03)Boston Scientific Corporation2003-02-08
Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/11.5 mm balloon Catalog # 4 recall (Z-0552-03)Boston Scientific Corporation2003-02-08
Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon15.5 mm balloon Catalog # 45 recall (Z-0553-03)Boston Scientific Corporation2003-02-08
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Every clearance here is in the API, with alerts when new ones post.