11 results
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18ms
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Sources: EU EUDAMED, US FDA
LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
A.R.T.™FEMORAL NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868005428·
Cameron-Miller
FDA UDI
CAMERON-MILLER INC·B3702609460·
CZ-S2000
FDA 510(k)
FDA Class 2
·Dental
4.0 and 6.5 Cancellous Bone Screw and Washer
FDA 510(k)
FDA Class 2
·Orthopedic
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·Product code NBW·September 11, 2012
STAPLE, IMPLANTABLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 19, 2014
COMPOUNDERS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code NEP·September 23, 2011
SURGICAL MESH
FDA Adverse Event
Injury
·CALDERA MEDICAL, INC.·Product code FTL·July 23, 2013
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013