6 results
·
37ms
·
Sources: EU EUDAMED, US FDA
CONFIRM CLEARLY
FDA Adverse Event
MIZUHO USA, INC·Product code LCX·January 31, 2007
Mizuho OSI Modular Table System; Product Usage: For use in orthopaedic surgery to provide support to a patient.
FDA Recall
Terminated
·Mizuho Orthopedic Systems Inc·Product code JEA·July 29, 2011
Coupler System II Mizuho Orthopedic Systems, Inc. Union City, CA 94587 The 5873 Coupler II is designed for use specifically with the Mizuho OSI Modular Base and the Spinal System Table Tops (AKA Jackson Spinal Table Top). The Coupler II mounts onto the Spinal Surgery Top by using the Spinal Top Adaptor Brackets. The 5873 Coupler II is used to allow positioning of a patient on the table utilizing either a skull clamp or horseshoe headrest for cranial stabilization or support during surgical procedures. The Coupler II can be accommodate either a radiolucent or aluminum skull clamp manufactured by Integra Life Sciences, referred to as a Mayfield clamp or the radiolucent or aluminum skull clamp referred to as the DORO which is manufactured by pro med instruments Inc.
FDA Recall
Terminated
·Mizuho Orthopedic Systems Inc·Product code FWZ·February 27, 2012
Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, Product Code 30136 and Confirm Clearly Refills Kits, Product Code 30138) Note: (1) Confirm Clearly Starter Kits: When sold in the U.S., the product consists of a reader and two disposable test sticks; when sold in Canada, the product consists of a reader and one disposable test stick (2) Confirm Clearly Refills Kits: The refill consists of three disposable test sticks.
FDA Recall
Terminated
·Mizuho USA, Inc.·Product code LCX·November 17, 2006
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
Promedics Medizinische Systeme GmbH
Importer
🇩🇪 Germany·12 Manufacturers