11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MIM-Ablation
FDA 510(k)
FDA Class 2
·Radiology
Symmetry Ribbon
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482045732·Symmetry® Retractor, Ribbon, Malleable, 2 1/2 i...
UNICEM
FDA 510(k)
FDA Class 2
·Dental
ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·November 24, 2025
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·November 3, 2014
PENTA SURGICAL LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 16, 2011
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013
VERCISE CARTESIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·November 22, 2024
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
FDA Enforcement
Class II
·Ongoing·GE Healthcare Finland Oy·July 3, 2024