11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
.22 & 1.2 MICRON IV FILTERS
FDA 510(k)
FDA Class 2
·General Hospital
QCT PRO 3D Volumetric Spine Software
FDA UDI
MINDWAYS SOFTWARE, INC.·B052QCTPROM0SS0·Convenience Kit consisting of
- QCT Bone Minera...
QCT PRO 3D Volumetric Spine System
FDA UDI
MINDWAYS SOFTWARE, INC.·B052QCTPROM3SS0·Convenience Kit consisting of
- QCT Bone Miner...
QCT Bone Mineral Density Analysis Software
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DIQCTPRO0·The method of Quantitative Computed Tomography ...
PATIENT EXAMINATION GLOVES (LATEX)
FDA 510(k)
FDA Class 1
·General Hospital
MANUAL RONGEUR
FDA 510(k)
FDA Class 1
·Orthopedic
9/10 COCR HEAD 28MM +6
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code JDI·June 25, 2014
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD/HUNTINGTON·Product code HQL·November 5, 2010
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 20, 2012
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Enforcement
Class II
·Ongoing·Abbott Point Of Care Inc.·September 24, 2025
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025