8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
GLAUCOMA-SCOPE
FDA 510(k)
FDA Class 2
·Ophthalmic
STENTUBE LACRIMAL INTUBATION SET
FDA 510(k)
FDA Unclassified
·Unknown
MODIFICATION TO ALPHA DX SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INFUSOMAT SPACE
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·May 19, 2014
BREAST IMPLANT STYLE 330
FDA Adverse Event
Malfunction
·ALLERGAN·Product code FWM·November 14, 2010
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 14, 2013
Axiom Aristos FX and FX Plus System Intended use: Stationary x-ray system
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code KPR·February 17, 2011
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015