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Boston Scientific Corporation

890 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradi recall (Z-0900-2014)Boston Scientific Corporation2014-01-30
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Nu recall (Z-0719-2014)Boston Scientific Corporation2014-01-11
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Nu recall (Z-0720-2014)Boston Scientific Corporation2014-01-11
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product N recall (Z-0721-2014)Boston Scientific Corporation2014-01-11
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Nu recall (Z-0722-2014)Boston Scientific Corporation2014-01-11
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Nu recall (Z-0723-2014)Boston Scientific Corporation2014-01-11
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used recall (Z-0724-2014)Boston Scientific Corporation2014-01-11
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M recall (Z-0710-2014)Boston Scientific Corporation2014-01-10
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: recall (Z-0711-2014)Boston Scientific Corporation2014-01-10
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN : recall (Z-0712-2014)Boston Scientific Corporation2014-01-10
Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalo recall (Z-0440-2014)Boston Scientific Corporation2013-12-04
Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog recall (Z-0441-2014)Boston Scientific Corporation2013-12-04
Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog recall (Z-0442-2014)Boston Scientific Corporation2013-12-04
Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The P recall (Z-2137-2013)Boston Scientific Corporation2013-09-03
Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x recall (Z-2138-2013)Boston Scientific Corporation2013-09-03
Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M00 recall (Z-1748-2013)Boston Scientific Corporation2013-07-17
RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Produc recall (Z-1671-2013)Boston Scientific Corporation2013-07-10
NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M006 recall (Z-1672-2013)Boston Scientific Corporation2013-07-09
NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: recall (Z-1673-2013)Boston Scientific Corporation2013-07-09
LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), ( recall (Z-0079-2013)Boston Scientific Corporation2012-10-18
Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, monopolar, electrosurg recall (Z-0080-2013)Boston Scientific Corporation2012-10-18
Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended f recall (Z-0081-2013)Boston Scientific Corporation2012-10-18
Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Po recall (Z-1850-2012)Boston Scientific Corporation2012-06-21
Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner P recall (Z-1851-2012)Boston Scientific Corporation2012-06-21
Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inner P recall (Z-1852-2012)Boston Scientific Corporation2012-06-21
Boston Scientific, IMAGER II Urology Torque Catheter, Sterilized with ethylene oxide gas. recall (Z-1393-2012)Boston Scientific Corporation2012-04-11
Boston Scientific, IMAGER II Angiographic Catheter, Sterilized with ethylene oxide gas. Ma recall (Z-1394-2012)Boston Scientific Corporation2012-04-11
Boston Scientific Soloist Single Needle Electrode: 18 cm long, 16 gauge, Sterile, packaged recall (Z-1319-2012)Boston Scientific Corporation2012-03-28
Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, Manufa recall (Z-0264-2012)Boston Scientific Corporation2011-11-21
Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002 Us recall (Z-3215-2011)Boston Scientific Corporation2011-09-16
Katzen" Infusion Wire, 0.035 in x 180 cm, UPN Product No. M001461930, RED Catalog No. 46-1 recall (Z-3053-2011)Boston Scientific Corporation2011-08-23
The Resolution II Clip, 155 cm size and 235 cm size, Boxes of 1, 10, and 20 clips consists recall (Z-3056-2011)Boston Scientific Corporation2011-08-22
Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repai recall (Z-2931-2011)Boston Scientific Corporation2011-08-03
Boston Scientific, WALLSTENT" Endoprosthesis & WALLSTENT" RP Endoprosthesis, Self Expandin recall (Z-2832-2011)Boston Scientific Corporation2011-07-15
Boston Scientific, WALLGRAFT OVER-THE-WIRE, Tracheobronchial Endoprosthesis, Made in IRELA recall (Z-2833-2011)Boston Scientific Corporation2011-07-15
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0510 recall (Z-2469-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0512 recall (Z-2470-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0515 recall (Z-2471-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0518 recall (Z-2472-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0520 recall (Z-2473-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0540 recall (Z-2474-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0560 recall (Z-2475-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0580 recall (Z-2476-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0602 recall (Z-2477-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0610 recall (Z-2478-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0612 recall (Z-2479-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0615 recall (Z-2480-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0618 recall (Z-2481-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0620 recall (Z-2482-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0640 recall (Z-2483-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0660 recall (Z-2484-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0680 recall (Z-2485-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0702 recall (Z-2486-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0710 recall (Z-2487-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0712 recall (Z-2488-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0715 recall (Z-2489-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0718 recall (Z-2490-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0720 recall (Z-2491-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0740 recall (Z-2492-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0760 recall (Z-2493-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0780 recall (Z-2494-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0802 recall (Z-2495-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0810 recall (Z-2496-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0812 recall (Z-2497-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0815 recall (Z-2498-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0818 recall (Z-2499-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0820 recall (Z-2500-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0840 recall (Z-2501-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0860 recall (Z-2502-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-0880 recall (Z-2503-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-4050 recall (Z-2504-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0502 recall (Z-2505-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0510 recall (Z-2506-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0512 recall (Z-2507-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0515 recall (Z-2508-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0518 recall (Z-2509-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0520 recall (Z-2510-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0540 recall (Z-2511-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0560 recall (Z-2512-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0580 recall (Z-2513-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0602 recall (Z-2514-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0610 recall (Z-2515-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0612 recall (Z-2516-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0615 recall (Z-2517-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0618 recall (Z-2518-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0620 recall (Z-2519-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0640 recall (Z-2520-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0660 recall (Z-2521-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0680 recall (Z-2522-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0702 recall (Z-2523-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0710 recall (Z-2524-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0712 recall (Z-2525-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0715 recall (Z-2526-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0718 recall (Z-2527-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0720 recall (Z-2528-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0740 recall (Z-2529-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0760 recall (Z-2530-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0780 recall (Z-2531-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0802 recall (Z-2532-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0810 recall (Z-2533-2011)Boston Scientific Corporation2011-06-16
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Every clearance here is in the API, with alerts when new ones post.