13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OSSEOFLEX SB
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257142530·20-30 MFW VITALITY CALF CT CHOC VII
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257125410·20-30 MV FOR MEN CLSC CALF STD BROWN VII
PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TEM 3000 HEAD COIL
FDA 510(k)
FDA Class 2
·Radiology
INCLUSIVE MINI IMPLANT O-BALL 3.0 MMD X 13 MML
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 29, 2024
Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 6, 2019
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 3, 2013
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 27, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008
NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.
FDA Enforcement
Class II
·Terminated·Nidek Inc·September 4, 2013
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·September 24, 2014