9 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
FDA 510(k)
FDA Class 1
·Microbiology
K2-HF OPAQUE DENTIN, OD-B2, 50g.
FDA UDI
Yeti Dentalprodukte GmbH·EYET38626070·
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981144708·Modular Trial 16x14x7mm, 15 Deg Lordosis, w/ De...
POLYGRAFT BGS
FDA 510(k)
FDA Class 2
·Orthopedic
BeneVision Central Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 8, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 23, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 10, 2012
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015