10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Nu-Edge Cobalt Chromium Brackets
FDA UDI
TP ORTHODONTICS INC·00192029045558·UR CUS W/HK
N/A
FDA UDI
Tyber Medical, LLC·M695M9302310·
Grasping forceps
FDA UDI
SOPRO-COMEG GmbH·04059082023090·
CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON
FDA 510(k)
FDA Class 2
·Cardiovascular
NON-CONTACT INFRARED THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·January 25, 2013
ECHELON*FLEX45
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 16, 2010
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Death
·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 11, 2014
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014