11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITEK 2 AST-ST TIGECYCLINE
FDA 510(k)
FDA Class 2
·Microbiology
Oticon
FDA UDI
Oticon A/S·05707131256430·NERA, BTE 13 WL 85 DBL
CADSTREAM
FDA 510(k)
FDA Class 2
·Radiology
CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CANTATA 2.9 SUPERSELECTIVE MICROCATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·September 14, 2017
4.5MM LCP® CONDYLAR PLATE 8 HOLES/206MM-RIGHT
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HRS·May 29, 2013
CARELINK PROGRAM W/TELEMETRY C
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·June 16, 2011
INSIGNIA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014
Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE HI-FI SUTURE
FDA Adverse Event
Malfunction
·CONMED CORPORATION·Product code MBI·April 23, 2019
FUSION 8MM-40CM UNSUPP PERIPHERAL GRAFT
FDA Adverse Event
Malfunction
·MAQUET CV·Product code DSY·February 8, 2017
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