8 results
·
24ms
·
Sources: EU EUDAMED, US FDA
PATIENT MOVER(TM)
FDA 510(k)
FDA Class 2
·Physical Medicine
Patterson
FDA UDI
PATTERSON DENTAL SUPPLY, INC.·D6620708715821·FILE, PULP CANAL, ENDODONTIC
HOLESTEROL DELTA TEST ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NEO Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 13, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 15, 2010
DESARA SLING
FDA Adverse Event
Injury
·CALDERA MEDICAL, INC.·Product code FTL·December 7, 2012
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