8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
OCULASE 514 OPHTHALMIC ARGON LASER
FDA 510(k)
FDA Class 2
·Ophthalmic
K133532
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·February 2, 2021
ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ALARIS SYSTEM WITH GUARDRAILS SUITE MX
FDA 510(k)
FDA Class 2
·General Hospital
530G INSULIN PUMP
FDA Adverse Event
Injury
·Product code OZO·May 27, 2014
ANCHOR C 7MM INSERTER
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code ODP·October 29, 2012
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·September 14, 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