8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
EYE SPEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
NA
FDA UDI
Richard Wolf GmbH·04055207040263·HOOK PUNCH WITH SHOVEL Ø 3.4MM particularly su...
PRO X OTC 5
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 30, 2014
CANCELLOUSSCR Ø4 L20/8 SST
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·November 20, 2012
45MM ARTICNG
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 21, 2010
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018