3 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·November 18, 2015
Stryker brand Cart with Isolation Transformer, Model Numbers: 240-099-001, 240-099-001K, 240-099-011, 240-099-011K, 240-099-020, 240-099-020K, 240-099-050, 240-099-072. 240-099-001, 240-099-001K, 240-099-011, 240-099-011K, 240-099-020, 240-099-020K, 240-099-050, 240-099-072, Product is manufactured and distributed by Stryker Endoscopy San Jose, CA The product is indicated for use in the carts include an isolation transfer and a power cord for connecting the transformer to an electrical outlet as means of providing power to the cart for the equipment it houses.
FDA Recall
Terminated
·Stryker Endoscopy·Product code GCJ·April 16, 2010
Guardian Services, Part Number 0240-009-430 with Part Numbers: 0240-030-004 and/or 0240-030-002, 0240-030-008 (Net Practice). The intended us of Guardian is to act as a medical data backup and disaster recovery plan.
FDA Recall
Terminated
·Stryker Imaging·Product code LMB·July 31, 2009