32 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices
FDA 510(k)
FDA Class 2
·Orthopedic
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189428·Apex Revision Knee System - Revision Tibia Ream...
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668101100·HELVESTON "GREAT BIG BARBIE" RETRACTOR 11MM
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189411·Apex Revision Knee System - Revision Tibia Ream...
OTOMAG BONE CONDUCTION HEARING SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CONDUCTOR CORONARY GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025
REZUM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·March 13, 2026
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·September 12, 2019
REZUM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·January 13, 2026
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 21, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 18, 2013
XEN 45 GTS
FDA Adverse Event
Injury
·ALLERGAN (IRVINE)·Product code KYF·February 11, 2022
XEN 45 GTS
FDA Adverse Event
Injury
·ALLERGAN (IRVINE)·Product code KYF·February 11, 2022
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025