9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
CATHETERIZATION PROCEDURE TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517356512·CoRoent Small Interlock Guide, 7mm DTS
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471162392·Comfort Hook™ Direct Bond Buccal Tube, Nonconve...
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Breast BI 7 MR Coil 1.5T Mammavention
FDA 510(k)
FDA Class 2
·Radiology
ADVANCE 1000 ADVANCE FRAME
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·May 6, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 3, 2014
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 10, 2012
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025