41 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HTx Disposable Hysteroscope System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Comprehensive® SRS
FDA UDI
Biomet Orthopedics, LLC·00880304540422·
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551112389·HALO, 1203-5 VEST MEDIUM, LAMBSWOOL LINER, 1211...
REGAL MOTOTRIZED 3 WHEELED VEHICLE
FDA 510(k)
FDA Class 2
·Physical Medicine
ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·November 7, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·May 23, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·March 25, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·October 28, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·December 12, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 4, 2025
CRYOMAZE
FDA Adverse Event
Malfunction
·MEDTRONIC ATS MEDICAL·Product code OCL·August 1, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·July 8, 2013
COMPR SRS MOD RGX AUG - SM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·March 20, 2019
COMPR SRS SEAS HMRL HEAD 48X19
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·March 20, 2019
COMPR SRS MOD STEM - 6X75MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·March 20, 2019
COMPR SRS TUMOR BDY - 61MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·March 20, 2019