11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER
FDA 510(k)
FDA Unclassified
·Unknown
K2-HF SHOULDER, SH-2 T powder, 20g.
FDA UDI
Yeti Dentalprodukte GmbH·EYET38622030·
POGO Automatic Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TINA-QUANT D-DIMER TEST SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
HARMONYCA LIDOCAINE, 2X1.25ML
FDA Adverse Event
Injury
·PANAXIA LTD·Product code LMH·July 22, 2025
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·June 10, 2014
TROCAR SLEEVE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GCJ·October 4, 2010
CAM TIGHTENER SHAFT
FDA Adverse Event
Malfunction
·DEPUY RAYNHAM·Product code LXH·December 7, 2012
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code JJE·January 26, 2023
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·March 22, 2023
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012