12 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Bright Tray
FDA UDI
ORMCO CORPORATION·00889989059724·BRIGHT TRAY-UPPER-SIZE 10-PURPLE-PK 20
ELMED
FDA UDI
ELMED INCORPORATED·00842180134935·ELMED REUSABLE MONOPOLAR ELECTRODES - LOOP ELEC...
HEMOSTAT ROCHESTER-OCHSNER 6 1/4" (16CM) CURVED
FDA UDI
W.H. Holden, Inc.·D9281400410·
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319704462·Kelly Hemostatic Forceps 7" (18cm), curved
4.0MHZ PENCIL PROBE 10'
FDA UDI
PARKS MEDICAL ELECTRONICS, INC.·00816787020571·
SHEATHES STERILE ULTRASOUND GEL
FDA 510(k)
FDA Class 2
·Radiology
NIO 3MP MEDICAL GRAYSCALE DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 3, 2014
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING·Product code FJI·May 29, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 25, 2011
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