8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
FOLDING LITTER SUPPORT, NSN6530-00-660-0034
FDA 510(k)
FDA Class 1
·General Hospital
PARIETEX POLYESTER MESH WITH INTRODUCER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ABCcolla Bone Graft
FDA 510(k)
FDA Class 2
·Orthopedic
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 15, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 29, 2014
DESARA
FDA Adverse Event
Injury
·CALDERA MEDICAL, INC.·Product code FTL·December 7, 2012
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024
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