8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COAGULATION CONTROL LEVEL 1 (NORMAL)
FDA 510(k)
FDA Class 2
·Hematology
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984129·anteriors; shade A3; mould 97
BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET
FDA 510(k)
FDA Class 2
·Cardiovascular
BILIBLANKET PHOTOTHERAPY DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 28, 2013
COLLEAGUE VOLUMETRIC INFUSOR PUMP-SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 10, 2011
1.4MM X 12.8MM FLUTED ROUTER
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·December 18, 2013
SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corp.·October 8, 2014