8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
SIMPLEX X
FDA 510(k)
FDA Class 2
·Orthopedic
PEDIACYN ATOPIC DERMATITIS HYDROGEL
FDA 510(k)
FDA Unclassified
·Unknown
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 6, 2013
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·May 29, 2013
SYNCHRON CX9 ALX
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJC·June 17, 2011
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 1, 2014
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