11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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syngo.via MI Workflows; Scenium; syngo MBF
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Medos International Sàrl·10886705032136·HD C-Mount Arthroscope/Sinuscope compatible wit...
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122315·KWire .094 x 9" (2.4x225mm)
MORELAND
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295123446·MORELAND REV INST MEDIAL OSTEOTOME 12mm
VISTAKON (SENOFILCON A) SOFT CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 2, 2025
GDC-10 SOFT 2D SR COIL
FDA Adverse Event
Injury
·NEUROVASCULAR DIV, BOSTON SCIENTIFIC CORP·Product code HCG·November 19, 2008
UNICEL® DXC 800 SYNCHRON® SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 10, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 23, 2013
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025