13 results
·
25ms
·
Sources: EU EUDAMED, US FDA
NOMAD TM-3400
FDA 510(k)
FDA Class 2
·Neurology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994617774·LID 1850109 SCREW CADDY LID
Ceramco® iC
FDA UDI
Dentsply International Inc.·D00148501090·
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981123970·14x13x9mm, 7 Degree, No Profile Integrated Spacer
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011850109000·Standard Band, Tooth 13/23, Size 9
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·00889981123973·No Profile Spacer, 14x13x9mm, 7 Degree, Sterile
TRILLIUM BIOPUMP PLUS, MODEL BPX80T
FDA 510(k)
FDA Class 2
·Cardiovascular
Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology
FDA 510(k)
FDA Class 2
·General Hospital
NIM-ECLIPSE® CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 4, 2014
SAVVY
FDA Adverse Event
Malfunction
·CORDIS (A JOHNSON & JOHNSON COMPANY)·Product code LIT·October 12, 2012
TOTALCARE-TREAT SURFACE&SCALE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·September 28, 2010
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021