98 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Rosso
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Comprehensive SRS
FDA UDI
Biomet Orthopedics, LLC·00880304507876·
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551112396·HALO, 1203-5 VEST MEDIUM, LAMBSWOOL LINER, 1211...
Clavicle Plate 3.5mm
FDA UDI
I.T.S. GmbH·09120034305207·Clavicle Plate 3.5mm, 8-Hole
PONTO BONE ANCHORED HEARING SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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
TM RVS BASE PLT 25MM POST +2
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 25, 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·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
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 28, 2026
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
COMPREHENSIVE SEGMENTAL REVISION SYSTEM SEAS HUMERAL HEAD 48X19
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·June 1, 2018
COMPREHENSIVE SEGMENTAL REVISION SYSTEM MODULAR STEM - 10X75MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·June 1, 2018
TM REVERSE 36MM GLENOSPHERE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 25, 2025
COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 19, 2025