9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EliA M2 Immunoassay
FDA 510(k)
FDA Class 2
·Immunology
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704512755·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515235090·Malis Style, Ti, BP Fcps, bay, 1.5 str mirror t...
CADSTREAM, VERSION 5.0
FDA 510(k)
FDA Class 2
·Radiology
GLIDECROSS SUPPORT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
MEDTRONIC MINIMED·Product code OYC·October 17, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·June 21, 2013
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
FDA Enforcement
Class II
·Terminated·Cardiovascular Systems Inc·May 31, 2017