19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dental Air Polishing Handpiece
FDA 510(k)
FDA Class 1
·Dental
Tyber Medical
FDA UDI
Tyber Medical, LLC·M695502P221548S1·PLIF 22mm x 8mm x 15mm x 4 °, TyPEEK, Sterile
Tyber Medical
FDA UDI
Tyber Medical, LLC·M695302P221548S1·PLIF 22mm x 8mm x 15mm x 4 °, PEEK, Sterile
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
FDA 510(k)
FDA Class 2
·Orthopedic
FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GMK SPHERE CEMENTLESS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MBH·May 25, 2026
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2024
GMK 3D METAL TIBIAL TRAY
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 12, 2025
GMK SPHERIKA CEMENTLESS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MBH·March 16, 2026
COBAS 6000 E601 MODULE
FDA Adverse Event
Malfunction
·HITACHI HIGH TECH. CORP.·Product code JJE·November 5, 2008
XCEL DILATING TIP TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·August 24, 2011
MERIDIAN FILTER SYSTEM- FEMORAL
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·July 1, 2013
GMK SPHERIKA CEMENTLESS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MBH·December 19, 2025
GMK SPHERIKA CEMENTLESS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MBH·December 24, 2025
GMK 3D METAL TIBIAL TRAY
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 11, 2025
MECTALIF ANT - LAG
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code PHX·January 27, 2025
GMK 3D METAL TIBIAL TRAY
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 29, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025