11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MATRIX HOLTER SYSTEM, MODEL M12
FDA 510(k)
FDA Class 2
·Cardiovascular
PYRAMESH® C Titanium Mesh
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490484565·PYRAMESH IMPL 17MMX22MMX30MM
PYRAMESH® C Titanium Mesh
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000855710·PYRAMESH IMPL 17MMX22MMX30MM
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106150·HOSKIN #30 COLIBRI FORCEPS
ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE
FDA 510(k)
FDA Unclassified
·Unknown
GC FUJICEM
FDA 510(k)
FDA Class 2
·Dental
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 10, 2013
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 12, 2011
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS CORP.·Product code LFR·May 19, 2008
SPEEDICATH COMPACT EVE
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code GBM·June 4, 2018
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018