7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
RF-1 CIRCUIT
FDA 510(k)
FDA Class 2
·Radiology
STAT/LYTE ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver
FDA 510(k)
FDA Class 2
·Orthopedic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 13, 2014
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·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