9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Eclipse System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171029281·PESSARY, RING #6, W/KNOB AND W/O SUPPORT, 3.25"
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012
MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F
FDA 510(k)
FDA Class 2
·Cardiovascular
QUANTA DIODE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZIMMER NATURAL NAIL 6.0MM CANCELLOUS SCREW
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSB·June 22, 2011
IPUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 6, 2013
MESH - COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·September 4, 2008
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017