20 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Thermage CPT System and Accessories
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
THERMAGE CPT SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code GEI·November 12, 2020
THERMAGE CPT SYSTEM TIP
FDA Adverse Event
Injury
·SOLTA MEDICAL INC·Product code GEI·November 30, 2022
ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT
FDA 510(k)
FDA Class 2
·Dental
AVAIRA (ENFILCON A) CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·March 31, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·June 11, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·May 30, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·March 5, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·June 5, 2025
VERCISE GENUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·March 8, 2023
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·January 28, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·July 28, 2025
HUT EXT DR FINAL ASSY-REVERSE
FDA Adverse Event
Malfunction
·LIEBEL FLARSHEIM·Product code IXR·October 15, 2014
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 24, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 17, 2013
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·September 30, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·May 12, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·January 10, 2025
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017