10 results
·
17ms
·
Sources: EU EUDAMED, US FDA
EMDS(TM) MAGNESIUM TESTPACKS, #67671/95
FDA 510(k)
FDA Class 1
·Clinical Chemistry
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190561·A/P Sizing and Distal Cutting Block 6deg Drill...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197536387·Balfour central blade
75x50mm
Kangaroo Feeding Tube with IRIS Technology
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ALTRA PRESS-FIT HIP SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·October 16, 2024
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 9, 2010
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·December 10, 2012
NOVATION ELEMENT FEMORAL STEM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code LPH·June 6, 2014
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025