13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BruxZir Incisal Coloring Liquid
FDA 510(k)
FDA Class 2
·Dental
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776182731·Leksell-Stille Rong cvd DA
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780382782·Integra® Jarit® Leksell Rongeur, 9-1/4", 5mm Bi...
Ormco
FDA UDI
ORMCO CORPORATION·00889989055016·CRIMPABLE STOP 2MM 19 I.D. X 30 O.D. PK40
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573020607·INTRG WHISP-Z MBT 1BIC HK -12T 0A 018 LL
devemed
FDA UDI
devemed GmbH·04061644024698·Atraumatic tweezers, micro
"Cooley" 1.3 mm, str...
MAGNETOM ESSENZA WITH SYNGO MR D14
FDA 510(k)
FDA Class 2
·Radiology
L100 Go System
FDA 510(k)
FDA Class 2
·Neurology
CLP
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWY·November 7, 2008
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 16, 2013
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026