9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GENASIS HIPATH IHC FAMILY
FDA 510(k)
FDA Class 2
·Hematology
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925017375·LARGE APPLEBAUM INCUDO-STAPEDIAL JOINT PROSTHES...
DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN CEONCENTRATION
FDA 510(k)
FDA Class 2
·Anesthesiology
NOA III ENTERAL NUTRITION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
RADIAL JAW? 4
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FCL·June 3, 2013
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 27, 2011
CO-CR
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC., ORTHOPAEDIC DIV·Product code KWY·August 28, 2008
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
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·December 11, 2013