14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Fusion Compact Navigation System
FDA 510(k)
FDA Class 2
·Neurology
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161121532470·Crossbar Acetabular Reamer - 47mm
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·October 9, 2017
NUCLEUS 22
FDA Adverse Event
Malfunction
·COCHLEAR LTD·Product code MCM·September 4, 2019
VASCUCOMP
FDA 510(k)
FDA Class 2
·Cardiovascular
VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·August 9, 2017
ATTAIN ABILITY PLUS
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·June 8, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 7, 2011
DUROM US ACETABAR COMPONENT 56/50 P
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·September 5, 2008
BD BACTEC¿ STANDARD ANAEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 8, 2022
AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.
FDA Enforcement
Class II
·Terminated·Vision Rt Inc·January 14, 2015
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023