8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
DART ALPHA-AMYLASE REAGENT SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040
FDA 510(k)
FDA Class 2
·Anesthesiology
F&P Optiflow Flow Diverter
FDA 510(k)
FDA Class 2
·Anesthesiology
DEPUY ASR XL FEM IMP SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·May 27, 2014
SPIROS CONNECTOR
FDA Adverse Event
Other
·ICU MEDICAL, INC.·Product code FPA·June 1, 2010
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·November 15, 2012
ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·August 14, 2019
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