11 results
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18ms
·
Sources: EU EUDAMED, US FDA
SENTINOL -ORTHODONTIC ARCH WIRE
FDA 510(k)
FDA Class 1
·Dental
Signature
FDA UDI
SILEX MEDICAL, LLC·B3315851055·Heavy Cup Tooth Grasping Forceps
Signature
FDA UDI
SILEX MEDICAL, LLC·B331585105545·Long Heavy Cup Tooth Grasping Forceps
MINI OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K85055231·MINI OVATION® Base Rx 022 UL/5-5 CS HK
MINI OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K85055241·MINI OVATION® Base Rx 022 UL/5-5 CS-BC MHK
INTRABEAM SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE
FDA 510(k)
FDA Unclassified
·Unknown
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·February 12, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 29, 2012
SIMPLEX BONE CEMENT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS LIMERICK·Product code NDN·September 29, 2010
Siemens LANTIS 6.1 Oncology Information System with MEDOne Module, Linear Medical Accelerators; Product Numbers: 4503178, 5835991, 5851055; Product is manufactured by IMPAC Medical, Inc., Sunnyvale, CA. Medical charged-particle radiation therapy system.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·March 6, 2009