9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
INFLUENZA MAB TEST/INFLUENZA B TEST
FDA 510(k)
FDA Class 1
·Microbiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526799370·MANUMED ACTIVE WRIST RIGHT SILVER L
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132140·Trial, TLIF, 27L OB CRV 7Deg, 14mm
CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A
FDA 510(k)
FDA Class 2
·Radiology
TLINK DATA MANAGEMENT SYSTEM (DMS)
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 14, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-REDWOOD CITY·Product code MGB·December 2, 2010
INGENIO
FDA Adverse Event
Death
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 3, 2014
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024