42 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780743·LEVAMED ACTIVE ANKLE SUP SLVR L II
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551112334·HALO, 1203-5 VEST MEDIUM, LAMBSWOOL LINER, 1211...
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0112220·Tap, 4.75mm Cortical, SNI1
OneLIF™
FDA UDI
Novapproach Spine LLC·G07001332112220·Retention Plate, Oblique-Only, Large, 12 mm - 2...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112220·Tap, 4.75mm Cannulated, Fixed Sleeve
PORTABELL, MODEL 4200
FDA 510(k)
FDA Class 1
·Dental
MRI-Q 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
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
COMPREHENSIVE SEGMENTAL REVISION SYSTEM MODULAR RGX AUG - SMALL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·June 1, 2018
COMPR SRS IC SEG - 120MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·March 20, 2019