10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NuVasive BASE Interfixated Titanium System
FDA 510(k)
FDA Class 2
·Orthopedic
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·December 31, 2014
SCHWERT
FDA UDI
A. Schweickhardt GmbH & Co. KG·E89617059206E0·Surgical curette for microapical surgery
2,0 mm...
SMALL BONE WEDGE
FDA 510(k)
FDA Class 2
·Orthopedic
3.7MM/5.0MM DYNAMIC LOCKING SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 21, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 14, 2013
VICKS
FDA Adverse Event
Other
·KAZ, INC.·Product code KFZ·September 24, 2014
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025