8 results
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26ms
·
Sources: EU EUDAMED, US FDA
COLOTRAK OCCULT BLOOD TEST
FDA 510(k)
FDA Class 2
·Hematology
LOW PROFILE LUTHER SAFETY HUBER
FDA 510(k)
FDA Class 2
·General Hospital
SENSILIGHT MINI
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GOLD PROBE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code KNS·May 30, 2014
BARD GROSHONG NXT CLEARVUE
FDA Adverse Event
BARD ACCESS SYSTEM INC.·Product code DQY·October 11, 2012
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·September 21, 2010
VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS Chemistry Systems typically used in hospital laboratories. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. 510(k) #: K845027 (18 January 1985). Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CHI·October 9, 2006
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