7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
RESTCUE CC
FDA 510(k)
FDA Class 2
·Physical Medicine
AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ADHESIVE 14
FDA 510(k)
FDA Class 2
·Dental
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·January 18, 2013
ENTRUST VR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·December 13, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 9, 2014
Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·March 25, 2015