10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
FDA 510(k)
FDA Class 2
·Dental
CoRoent
FDA UDI
Nuvasive, Inc.·00887517300584·CoRoent® XLK, 18x18x45mm 10°
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074362540·SCREW 7221845 HA COATED CANN 8.5 X 45
STARDUST II, MODEL 1011176
FDA 510(k)
FDA Class 2
·Anesthesiology
SDX SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MECTALIF ANT - LAG
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024
LINOX TD 65/18
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code LWS·November 3, 2008
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·July 21, 2011
MICRO INCISION VACUUM PACK
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQC·July 9, 2013
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024