9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
FDA 510(k)
FDA Class 2
·Radiology
Riofoto™ Mirrors
FDA UDI
Ortho Organizers, Inc.·00190707055783·Riofoto™ Photo Mirror Buccal (Wide)
OPTI® B-Lac Cassette
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
FDA 510(k)
FDA Class 2
·Ophthalmic
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 14, 2014
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 31, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 29, 2013
5MM HEX FLEXIBLE SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·September 16, 2024
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021