11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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syngo®.via (version VB10A)
FDA 510(k)
FDA Class 2
·Radiology
AGXO
FDA UDI
Oticon A/S·05707131280930·H160V2, BTE 13 WL 100 STG AGXO
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ABREU, MODEL 700
FDA 510(k)
FDA Class 2
·General Hospital
ENSITE CLASSIC SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code DQK·February 9, 2010
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·September 23, 2016
SYNCHRO2-14 SUPPORT STRAIGHT 215CM
FDA Adverse Event
Malfunction
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 14, 2023
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 6, 2013
TOTAL ASR FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·June 29, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015