16 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WISE Cortical Strip (WCS)
FDA 510(k)
FDA Class 2
·Neurology
NEXT Coarse Kid's Variety Prophy Paste Box 200
FDA UDI
Preventech·D024221123·NEXT Coarse Kid's Variety Prophy Paste Box of 2...
Luna
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205004093·Luna Opal MB Mini .022 LL5 D/HK (-17°T +2°A)
BIOFUSIONARY BEBE
FDA 510(k)
FDA Class 2
·Physical Medicine
BACT/ALERT SN CULTURE BOTTLE
FDA 510(k)
FDA Class 1
·Microbiology
Widex
FDA UDI
Widex A/S·05706069810028·Widex EVOKE E-FS (Autumn Beige ) 220, Telecoil,...
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
AEYE-DS RETINA SCREENING
FDA Adverse Event
Injury
·AEYE HEALTH INC.·Product code PIB·January 22, 2025
ESSURE
FDA Adverse Event
Malfunction
·CONCEPTUS, INC.·Product code HHS·October 23, 2008
URETEX SUP URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·May 15, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 24, 2011
BACT/ALERT I NST 100 BTLS - 259785
FDA Adverse Event
Malfunction
·BIOMÉRIEUX INC.·Product code MDB·March 4, 2024
BAB FLEXIBLE FABRIC BANDAGES
FDA Adverse Event
Injury
·KENVUE·Product code KGX·November 1, 2024
BAB FLEXIBLE FABRIC BANDAGES
FDA Adverse Event
Injury
·KENVUE·Product code KGX·November 1, 2024
TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Surgical Vision Inc·March 10, 2021
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026