11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
FAIRBANKS BABY SCALE
FDA 510(k)
FDA Class 1
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743717·ACHIMED ACHILLES SUPP SAND II
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978956046·INSTRUMENT 8920812 12MM TAP
ZAVATION
FDA UDI
Zavation LLC·00842166152502·WHITNEY 14mmx16mm , 8deg , 12mm
DynaClip® Bone Staple
FDA 510(k)
FDA Class 2
·Orthopedic
RENAISSANCE
FDA 510(k)
FDA Class 2
·Neurology
HARMONIC SYNERGY* DISSECTING HOOK WITH TORQUE WRENCH
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 4, 2014
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·January 17, 2013
UNKNOWN DEPUY PINNACLE SHELL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·July 8, 2014
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013